Please Forward to @AndersonCooper and Others Who are Dismissing the Suffering of Thousands of Gardasil Injured Girls


ATTN: IMPORTANT INFORMATION ABOUT HPV VACCINE

Thirteen samples  of Gardasil from several countries and states within the USA were recently tested and 100% found to be contaminated with recombinant HPV DNA. The potential health consequences are serious, including autoimmunity and malignancies. Elsewhere on our site, can be found copies of press releases, and a letter to Commissioner Hamburg.

With the news release about Gardasil contamination with recombinant HPV DNA, more information about serious health risks has emerged from VAERS databases. As this issue has become national news becasue of Michele Bachmann’s remarks in the debate, we thought readers should have access to what the media is not telling them – than HPV vaccine contamination does cause severe adverse reactions, and many of them cause cognitive decline.

Please view the attachment regarding Gardasil injury reports. If you have received a Gardasil vaccine and are experiencing any of these symptoms, PLEASE GET TESTED FOR ANTI NUCLEAR ANTIBODY AND REPORT TO VAERS. Your reports could make a difference to other girls and boys who may consider risking their lives and or health by taking this vaccine.


25% of girls in recommended age groups have received this vaccine.

A search of the VAERS database for:

Gardasil & ANA positive

ANA is:

http://en.wikipedia.org/wiki/Anti-nuclear_antibody

http://arthritis.about.com/od/diagnostic/a/ana.htm
Antinuclear antibodies <http://arthritis.about.com/cs/diagnostic/g/ana.htm> are a unique group of autoantibodies that have the ability to attack structures in the nucleus of cells. The nucleus of a cell contains genetic material referred to as DNA (deoxyribonucleic acid).

There is an ANA (antinuclear antibody) test which can be performed on a patient’s blood sample as part of the diagnostic process to detect certain autoimmune diseases.

Alum+DNA makes Gardasil an anti-DNA vaccine.

This is just a sample of VAERS reports (Also, please note the case at the end: Guillan Bare Syndrome). Many many Gardasil girls suffer from arthralgias and lupus-like syndromes. Not all are tested for ANA. I think there would be more ANA+ cases if all girls affected got tested. I think this is the most likely explanation as to the potential impacts of HPV DNA contamination in Gardasil.

Also note that Sydney, the girl from Canada who tested positive for vaccine-strain HPV DNA, also came down with severe arthralgia following Gardasil.

The attached doc is 30 pages long, but highlighted are the most relevant info so it takes no longer than 5-10 minutes to scan through it.
VAERS ID

Results are sorted in by-variable order

Serious            Primary Reports

276825-1         Not Serious     Primary           1          1.35%  “Information has been received from a physician concerning his daughter, a female patient, with a penicillin allergy, who on 15-DEC-2006 was vaccinated with the first dose, 0.5ml, IM, of Gardasil. There was no concomitant medication. On approximately 15-JAN-2007 (“” one month later””) the physician’s daughter experienced “”numbness and pain in her right foot and leg.”” The physician reported that his daughter was examined by both a neurologist and a rheumatologist, and was not certain if she was “”experiencing significant disability,”” but was waiting to see if the numbness and pain resolved. The physician reported there was “”some improvement.”” Additional information has been requested. 01-Jan-2007 magnetic resonance imaging, Negative, 01-Jan-2007 serum C-reactive protein test, Negative, 01-Jan-2007 serum antinuclear antibodies test, Positive”

Total   1          1.35%

Total   1          1.35%

278150-1         Not Serious     Primary           1          1.35%  (1) Headache. (2) Numbness on arms and legs, (3) Joint swelling and pain (Elbows, wrist, (4) Hives and Macucopapular rash on arms and legs. Menactra verified.

Total   1          1.35%

Total   1          1.35%

279239-1         Not Serious     Primary           1          1.35%  Information has been received from a physician concerning a 19 year old female patient who was vaccinated with a dose of Gardasil. The patient experienced joint pain after getting the injection. Unspecified medical attention was sought. Patient’s outcome was unknown. Additional information has been requested. 07/06/07 This is in follow-up to report(s) previously submitted on 5/14/2007. Initial and follow up information by telephone has been received from a physician concerning a 19 year old female patient who was vaccinated with a first and second dose of GARDASIL. The patient experienced joint pain after getting her second injection. Follow up information from the physician indicated that the patient had a positive ANA and an increased sed rate and he was trying to rule out the possibility of lupus. The physician requested additional information about GARDASIL and lupus and whether or not the patient should receive her third injection. On 30-APR-2007 the patient recovered. Additional information has been requested.

Total   1          1.35%

Total   1          1.35%

279329-1         Serious            Primary           1          1.35%  Information has been received from a physician concerning a 15 year old female with no pertinent medical history or known drug reactions or allergies who on 03-JAN-2007 was vaccinated with Gardasil 0.5 ml injection. In February 2007, the patient experienced heavy menstrual bleeding, nose bleeds and eye problems and was hospitalized for four days (admittance and discharge dates not reported), and while hospitalized was diagnosed with Evans syndrome. The patient needed a blood transfusion. The patient’s Evans syndrome persisted. There was no product quality complaint. Additional information has been requested. 06/06/07-records received from facility for DOS 5/7-5/10/07. DC DX: Evan’s Syndrome, immune thrombocytopenia and anemia. Prolonged episode of epistaxis. HX: Nosebleeds frequently since age of 3 or 4. In last 4 weeks have increased in frequency 6-7 times per day, harder to stop. Prior to admission nosebleed from 21:30 through 9:30 with nausea and bloody emeses. HX of bruising easily. Menses 3 days longer in duration and heavier with clotting and clumps. Petechia on lower extremities, more tired or fatigued. Feels faints if she stands up too quickly. Black out this morning. Fell. Follow up visits 5/17/07: Impression Evan’s Syndrome, Strong family history of autoimmunity. Abnormal labs including positive ANA, low complement.

Total   1          1.35%

Total   1          1.35%

288225-1         Not Serious     Primary           1          1.35%  “Joint pains- hands and feet noted 6/11/07. Workup showed (+) ANA of 1:160. Patient read article from “”National Vaccine Information Center”” and would like this to be reported as a possible adverse event following Gardasil to VAERS”

Total   1          1.35%

Total   1          1.35%

288958-1         Not Serious     Primary           1          1.35%  Pt received 1st dose of Gardasil 5/21/07. Within 9 days she developed severe bilateral joint pain and stiffness with bilateral elbow effusion. Her ANA was 1:2560. Normal sed rate, RF, CBC, Mild elevation of liver function tests.

Total   1          1.35%

Total   1          1.35%

291240-1         Not Serious     Primary           1          1.35%  New onset ankle, knee, elbow, shoulder, back pain, no fever. Diagnosed arthralgia vs arthritis symptoms thus labs drawn.

Total   1          1.35%

Total   1          1.35%

293667-1         Not Serious     Primary           1          1.35%  This is in follow-up to report (s) previously submitted on 9/17/2007. Information has been received from a Nurse Practitioner concerning a 25 year old female with no allergies and no pertinent medical history who on 26-JUN-2007 was vaccinated with 0.5 ml intramuscularly GARDASIL. There was no concomitant medication. On 03-JUL-2007 the patient had a rash that initially itched but did not anymore. The rash was located on the arms and legs and the patient still had it. The patient took 7 medications (one of which was a steroid, others were unspecified) to treat the rash. The patient underwent 7 different blood tests which revealed a positive ANA. As of 21-AUG-2007 the patient was recovering. Additional information has been requested. Additional information is not expected.

Total   1          1.35%

Total   1          1.35%

297034-1         Serious            Primary           1          1.35%  Information has been received from a physician concerning a 15 year old female with no known medical history, drug reactions/allergies or concomitant medication use who at the end of August 2007 (exact date unknown), was vaccinated (site and route not reported) with the 1st dose of Gardasil (dose and lot# not reported). In the beginning of October 2007, the patient became very tired and later jaundiced with a low hemoglobin at 5. Laboratory evaluations revealed IgM positive to Epstein Barr virus, positive cold agglutinins, positive antibodies to mycoplasma and positive antinuclear antibodies (ANA). The patient was admitted to the hospital with Autoimmune Hemolytic Anemia for 2.5 weeks with blood transfusions given. The patient was discharged from the hospital (exact date not reported). The patient had been receiving steroids for approximately one week and was undergoing a steroid taper. The physician felt that the patient’s tiredness, jaundice and Hemolytic Anemia were considered disabling and life threatening and other important medical events. No ongoing hemolysis at the time. At the time of this report the patient was recovering. Additional information has been requested.

Total   1          1.35%

Total   1          1.35%

302337-1         Not Serious     Primary           1          1.35%  Persistent swelling L UE x6 months with continued tenderness & erythema. No F/U, positive mild pruritis. 5/2/08-records received-1/10/08-seen for C/O left upper extremity arm swelling, tenderness since 8/8/07-pain persistent since that time and now has 1-2 months swelling. Received her 3rd Gardasil injection in right arm without complaints. Seen 1/29/08 for C/O joint pains. Each vaccination produced pain at the site of injection without any erythema or site reaction. By end of series in December experienced migratory arthralgias including hips, knees, feet, toes and hands. Daily pain. Impression:arthralgias and positive ANA titer.

Total   1          1.35%

Total   1          1.35%

304987-1         Serious            Primary           1          1.35%  Received Gardasil injection #3 on 2/7/08. Few days later developed neck stiffness and joint pain/stiffness, tightness both legs & L arm where inj./fever on 3rd day x24 hrs. Can barely walk. Sent to ER. 03/17/2008 MR recieved for DOS 2/18-21/2008 with DX: Severe polyarthragia and weakness 2′ to SLE. Systemic Lupus Erythematosus. ADD. Anemia. Pt presented with hisory of joint pain and swelling, generalized weakness progressing to the point of having difficulty getting out of bed. PE (+) for tenderness of both feet, ankles and hands. Decreased hand grip. Rheumatology consult with assessment of polyarthralgias, fevers, myalgias and hypocomplementemia.

Total   1          1.35%

Total   1          1.35%

308474-1         Not Serious     Primary           1          1.35%  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

Total   1          1.35%

Total   1          1.35%

311580-1         Serious            Primary           1          1.35%  My daughter is currently in hospital on steroids. After receiving the vaccine Gardasil around March 14th – she began having a FOU for over 30 days. Her white & red blood count have dropped (8.0) and her immunity is active. Unknown cause. 5/16/08 Reviewed hospital medical records for 4/24-5/1/2008. FINAL DX: fever & leukopenia; autoimmune hemolytic anemia. Records reveal patient experienced fever for more than 30 days w/nausea, intermittent vomiting, malaise, poor appetite, weight loss, stomach discomfort, weakness, fatigue, HA, shotty cervical lymphadenopathy, muscle aches/pains, leukopenia, anemia & hepatitis. Exam revealed mild spenic enlargment & intermittent heart murmur. Heme & Rheum consults done. Tx w/steroids & d/c to home on continued steroids w/f/u. 5/23/08 Reviewed PCP medical records which included vax records, student health records, consultant records, hospital records & labs. Non-duplicated hospital records will be scaned. Records reveal patient was fatigued after vaccination on 3/14. Developed fever, chills, sore throat, body aches, decreased energy & seen by PCP on 3/21. Pts college roomate currently had mono. Dx w/viral syndrome. Began to feel very weak, had difficulty walking & soon became unable to complete college classes. Seen in student health center 3/31 w/fever, chills, sore throat, body aches, fatigue, nausea & mono-like symptoms. Dx w/viral syndrome & anemia. Health continued to decline w/vomiting, loss of appetite, weight loss, pain in low back & abdomen. Internal med consult 4/11/08. ID consult of 4/15/08 Admitted to hospital 4/24. Follow-up Information 22-MAY-2008: Pt was a freshman at university when she became ill in March 2008. She had received the second Gardasil Vaccine at doctor on March 14th, 2008. She felt fatigued after the vaccine and went to bed early that day. Since then, she has lost 25 lbs, and currently her WBC is (2.3) Lymp (14), Neut (1.9) HGB (9.6) platelet count (159) has developed hemolytic anemia. She was admitted and hospitalzied for FUO (fevers as high as 104) at hospital for 7 days and released on May 1, 2008. She tested positive for coombs, double-strand DNA and very high ANA in the 2500’s. She has been diagnosed by several Drs-all listed on next page: internists, infectious disease, hematologist and rhuematologist at the hospital. We are still unsure what is wrong with her. History: Patient became fatigued after receiving the vaccine. Her health began to decline and she followed up with a Pediatrician visit a week later. Mono tests were negative, diagnosis was viral. Patient returned to college and continued to feel weak and ill. Soon she developed lower leg weakness, vomitting, and fever. She started feeling very tired during activity and soon had difficulty walking to class and doing everyday activities. She began sleeping excessively, and feeling fluish. Dr examined her at the health clinic at university on 3-31 for fever, chills sore throat, body aches, fatigue, nausea

Total   1          1.35%

Total   1          1.35%

312897-1         Not Serious     Primary           1          1.35%  “Information has been received from a nurse concerning a 17 year old female with codeine intolerance who on 31-JAN-2008 was vaccinated intramuscularly with a 0.5 mL first dose of GARDASIL (lot # 659657/1487U). On 01-APR-2008 the patient was vaccinated intramuscularly with a 0.5 mL second dose of GARDASIL (lot # 659180/1758U). Concomitant therapy included hormonal contraceptives (unspecified). On 04-APR-2008, “”three days later””, the patient developed a rash on her legs. It was reported that she went to the emergency room. On 07-APR-2008 the patient was followed up at her doctor’s office and was diagnosed with vasculitis. On 09-APR-2008 the patient “”had a flare up again””. The nurse reported that she had “”many tests done””. At the time of this report the vasculitis persisted. The patient is being treated with prednisone. Laboratory tests performed on an unspecified date showed an “”elevated sed rate”” and an “”elevated white count””. Additional information has been requested. 6/3/08 Reviewed PCP medical records for 4/7-5/1/2008. FINAL DX: vasculitis Records reveal on 4/7 visit, patient experienced itchy rash over bilateral LEs, aching in bilateral LEs & muscle spasms. Had been seen in ER on 4/4, 2 days s/p 2nd HPV vax, & diagnosed w/vasculitis, unclear etiology. Had undergone tanning session on day of ER visit. Intolerant of steroids. Tx w/antihistamine. Had no reaction s/p 1st HPV vax. Exam revealed bilateral LE multiple erythematous round macules & plaques generalized over lower pretibial area. Returned to office 4/9 w/worsening symptoms of rash & calf pain. Exam at that time revealed tenderness of bilateral calves w/trace edema, diffuse nodular urticarial erythematous lesions, coalescent purpura mostly over distal tibial area w/sparse involvement over thighs. Attempted tx w/steroids & additional labs. Testing for celiac disease (+) on 5/1/08. 6/3/08 Reviewed ER medical records of 4/4/2008. FINAL DX: vasculitis Records reveal patient experienced rash which started at ankles & progressed”

Total   1          1.35%

Total   1          1.35%

312977-1         Not Serious     Primary           1          1.35%  Lower extremity pain and numbness and pins and needles, fatigue. Also with hand and lower arm weakness, multiple consults. Rheumatology, Psych, Emg – normal, MRI of head and spine – normal. 6/3/08 Reviewed PCP medical records. FINAL DX: (+)ANA syndrome w/arthralgia/alopecia; allergic rhinitis; exercise induced bronchospasm. Records reveal patient experienced alopecia areata (from age 2), arthralgia, lethargy, tiredness, eczema & joint stiffness in 2002. Episode of Lyme disease 9/2007 & developed tingling in hands & feet. Seen in ER 1/2008 w/increased weakness & tingling in hands & legs & difficulty walking. Had been on antibiotics for pyuria. Neuro & rheum consults done.

Total   1          1.35%

Total   1          1.35%

314559-1         Serious            Primary           1          1.35%  05/31/08- SOB and chest pain 06/01/08- Chest pain, pericardial effusion, Pericarditis 6/3/08-records received for DOS 5/31-6/2/08-DC DX: Pericarditis. Presented with chest pain for about 10 days and 2 days after vaccination for human papilloma virus.

Total   1          1.35%

Total   1          1.35%

316959-1         Not Serious     Primary           1          1.35%  Nausea for about a week,then felt good for about 3 week, then had burning sensation back of head and felt light headed and that lasted for about a week, then once again disappeared and then I got sick to my stomach, bad stomach pains that lasted about 6 weeks, then that went away then I had bad headaches with sharp shooting pains, burning sensations at the back and the front of the head, and had teethache even took trips to the dentist to find out everything was ok the duration of the headaches lasted about 3 1/2 months. Then had leg/muscle pains for about 3 weeks, joint pain, andchest pain, sensation of not able to get enough air that take place on in off over the past 8 months, and tireness. 7/15/08 Reviewed vax & PCP medical records. Received HPV #1, lot# 0525U, RA on 8/28/07. Records indicate patient tolerated HPV #1 well. 9/9/08 Reviewed additional PCP medical records. FINAL DX: none provided Records reveal patient experienced general good health on 8/28/07 but with bilateral ear discomfort & wisdom teeth coming in. RTC 7/15/08 & seen by Rheum c/o feeling unwell since 10/2007 w/multiple complaints of lightheadedness, nausea, HA, abdominal pain, sensitive teeth, burning ears, arthralgias, paresthesias, chest discomfort, difficulty breathing, feelings of impending doom, . Had been seen by GI & dx w/IBS. Seen by Neuro & exam was WNL. RTC 7/21/08 c/o nausea, tooth pain & increased heart rate, no diagnosis provided. RTC 8/12/08 for intermittent dizziness x several months, achy & joint pain

Total   1          1.35%

Total   1          1.35%

318890-1         Serious            Primary           1          1.35%  Patient had unusual persistence of weakness. Both legs, below knees, numbness, tingling sensations. Underwent extensive tests at hospital- all neg. 9/12/08-records received for DOS 9/20-9/21/07-DC DX: Peripheral neuropathy. Presented to ED with C/O bilateral lower extremity weakness/numbness began 2 days prior. Tingling began next day.PE: decreased sensation, strength 4/4 times four. End point nystagmus L>R. Follow-up with neurology clinic.

Total   1          1.35%

Total   1          1.35%

320032-1         Not Serious     Primary           1          1.35%  Information has been received from a consumer concerning her 16 year old daughter with chronic asthma who on 14-APR-2008 or on 16-APR-2008 was vaccinated with the first dose of GARDASIL vaccine (yeast). Concomitant therapy included montelukast sodium (MSD). The consumer reported that her daughter developed cardiac and auto immune issues after getting the first dose of GARDASIL vaccine. The patient was taken to the ER but not hospitalized. The patient had already seen a cardiologist and would be seeing a rheumatologist. On an unspecified date the patient had a stress test done (results not provided). The patient sought medical attention. Additional information has been requested. 9/17/08-cardiology consult notes received for DOS 6/11/08-Impression:rare, uniform premature ventricular contractions (PVCs). Mild mitral valve regurgitation without prolapse. Referred for C/O premature ventricular contractions. Over past two months C/O severe fatigue. On 5/23/08 episode of shakiness, dizziness and shortness of breath. Presyncope, headaches and pallor. 9/23/08-records received for DOS 1/28/08-well visit with PMH asthmatic. 4/29/08-chest congestion face swelling with puffy eyelids. Assessment sinusitis. 5/1/08-asthma attack, asthma exacerbation. 5/7/08-seen for C/O low right side of head pain possible muscle spasm in neck. Mild hyperplasia. Swollen nasal mucosal. Received first Gardasil vaccine. 5/22/08-C/O feeling weak, fatigue, lack of energy.

Total   1          1.35%

Total   1          1.35%

321265-1         Not Serious     Primary           1          1.35%  sudden onset bilat arthralgia; PE-neg labs-decreased platelet; refer hematologist decreased C3-C4-prednisone therapy increased DS DNA; refer rheumatologist 8/15/08 Reviewed PCP medical records which consisted of consultant records & labs. FINAL DX: ITP & probable drug induced lupus Heme/onc records reveal patient experienced joint aching & bruising. Tx w/steroids. Rheumatology records reveal patient evaluated for possible lupus erythematosus. Patient experienced extreme joint pain & fatigue that started several weeks after vaccinations. Then developed petechia on hands & feet which resolved w/steroids. ALso w/mild dyspnea. Follow-up Information 26-JUL-2008: This is a follow up on our mutual patient. She was referred to me by your nurse practitioner for thrombocytopenia. Her platelet was running in the range of 30,000. She also had ecchymosis and arthralgia. I have ordered workup. At the time when I did the CBC it showed her platelet acount was 31,000. I have reviewed her peripheral smear which showed she had giant platelet. Her thyroid function test was normal. Her C3 was low at 57, normal is 90-207. C4 level was less than 5.0, normal is 17-52. B12 level was low-normal 230. Folic acid was 16. ANA was negative, but initially her ANA was positive which was ordered by nurse practitioner. H. pylori was negative. Hepatitis profile was neagative. Immunoelectrophoresis was normal. Anticardiolipin antibody was 6, IgG and IgM, but anticardiolipin IgA level was less than 6. Double-stranded DNA was high at 294. Lyme titer was negative. Anti Smith antibody was 2. I have started her on prednisone 60 mg daily. Her platelet count today is 266,000. She is accompanied by her mother. I actually also referred her to another doctor for evaluation of lupus. SHe had seen the doctor this morning. Her mother was also with her. Patient is my office nurse. Doctor thinks that it is due to Gardasil. We have reviewed the literature. Seems to be Gardasil can cause drug-induced lupus. On today’s examination, her blood pressure is 98/70 which according to her mother is normal for her. She has no oral thrush. She has no petachiae. Her arthralgia has significantly improved. She has no pedal edema. Drug-induced lupus, possibly from Gardasil. Will taper off prednisone 10 mg each week. Will follow up lab work in about five weeks. I have discussed with her mother that if she develops thrush, she should call us. Otherwise, I will see her back in about five weeks. She will be having a weekly CBC to monitor her blood sugar, as well as her platelet count.

Total   1          1.35%

Total   1          1.35%

321906-1         Serious            Primary           1          1.35%  Had her second Gardasil vaccination at the end of August 2007, two weeks later suddenly developed pain in joints of hands, feet, knees and elbows. Pain got progressively worse and required emergency room visit when she could not bend her joints and was in extreme pain. Had multiple tests done and was given prednisone for the inflammation, pain medication and a referral to a Rhematologist. After 2 months of treatment with steroids and multiple blood tests for Lyme disease, Hepatitis and Lupus and others she was diagnosed with Rhematoid Arthritis. It came on out of the blue. She had never had any illness or symptoms prior to the sudden and unexplained onset. We went to the Clinic for a second opinion and they confirmed RA. She has been on Methetrexate and Enbrel which she will have to stay on for the rest of her life. She still has stiffness, pain and inflammation even with the drugs. This happened just after her second dose of Gardisal. I believe there is a connection, prior to that she was a strong healthy young woman with no history of any illness and never had joint pain. There is no history of autoimmune disease in either side of her family and it is extremely rare for RA to develop so suddenly and severely as it did in her case. 09/12/2008 MR received for ER visit 9/23/2007 with DX: arthralgias. Pt presented with c/o 1 week hx of joint pain, now worsening in legs, wrists and shoulder as well as low grade fevers and polymyalgia. Recently started on steroid taper by PCP however pain is now worse with lower extremity joint swelling. D/C on pain meds to f/u with rheumatologist. Rheumatology consult dated 9/28/07 with impression Inflammatory Arthritis in multiple joints. HPI as above now with morning stiffness > 1 hr, fatigue, night sweats, cold sensitivity, nausea and paresthesias in the hands and feet. PE (+) for limping gait, polysynovitis, shoulder, elbow and wrist tenderness with decreased ROM, PIP joints swollen and tender, effusions in both knees, ankles and forefeet tender. Started on prednisone. 11/24/08 Additional records received fron another Rheumatologist beginning 2/6/08 for sudden onset symmetric polyarthritis in 9/2007. Pt reports awoke one morning and could not move. Sx as above with addition of difficulty falling asleep. PE (+) for dry skin with MP rash on extremities and some periorbital swelling/erythema, joint swelling with decreased ROM. DX: Sero(+) RA, non-erosive. F/u 5/28/2008 reports increased pain and swelling and decreased appetite. Pt tearful re: loss of social life. 1/27/2010 Patient continues to suffer from an autoimmune disease we believe was a result of this vaccine

Total   1          1.35%

Total   1          1.35%

322403-1         Serious            Primary           1          1.35%  Information has been received from a physician concerning a 13 year old female with attention deficit disorder and no history of drug reactions or allergies who on 11-APR-2008 was vaccinated with the first dose of GARDASIL (LOT#: 659962/1740U) and on 16-JUN-2008 was vaccinated with the second dose of GARDASIL (LOT#: 660389/1968U). Concomitant therapy included oral birth control and ADDERALL. One week after the second vaccine (on approximately 23-JUN-2008) the patient developed joint pain that continued to get worse. She was not able to bath herself. She developed short term memory loss and blurred vision. The patient saw her primary physician and the physician ordered a magnetic resonance imaging (MRI) that revealed a cerebral vascular accident (CVA). The patient was hospitalized. Further diagnosis revealed the patient had lupus and antiphospholipid syndrome. As of 11-AUG-2008 the patient was recovering. Additional information has been requested. 08/25/2008 MR received from PCP from 6/13/08 to 8/7/08. Pt presented 6/13/08 for well check with normal exam and no c/o. Some recent weight loss due to increased activity while training for an athletic event. Seen again 7/1/08 with c/o 3 wk hx of arthalgias, myalgias, weight loss and fatigue. Pt reports poor memory. Subjective fever past weekend as well as swelling of R ankle. Recent ?tick bite. Seen again 7/10/08 with persistant arthralgias, fatigue, muscle aches and loss of vigor. Currently with night sweats and increased transaminases. Rheumatology consult 8/7/08 with DX: SLE characterized by a midbrain stroke and positive labs. On anticoagulants for the CVA. MD reports sx started after 2nd Gardasil dose. PE (+) for several areas of bruising, otherwise WNL. 9/10/2008 MR received for DOS 7/29-8/01/2008 with D/C DX: Antiphospholipid syndrome. Positive ANA, questionable reactive vs true Systemic Lupus Erythematosus. Ischemic stroke. Pituitary adenoma as an incidental finding on MRI. Pt presented with 5 week hx of myalgias, one week hx of vision changes as

Total   1          1.35%

Total   1          1.35%

322833-1         Serious            Primary           1          1.35%  “Information has been received from a consumer on a news station reporting that her teenage daughter (age not reported) was vaccinated with GARDASIL in December 2007. Subsequently in February 2008, 2 months after receiving GARDASIL the patient developed an “”autoimmune disease””. The patient developed a rash on her face and arms, leaving scars. She had swelling all over, pain in her joints and poor circulation in her fingertips. Her doctor says “”she now suffers from an autoimmune disease and says it is possible the GARDASIL triggered her illness””. The mother stated that her daughter had no prior illness or hospitalization. At the time of reporting the patient had not recovered. Upon internal review autoimmune disease was an other medical event. The reporter felt that the autoimmune disease was disabling. Additional information is not expected. 11/21/08 Reviewed PCP medical records o 12/12/07-10/01/2008. FINAL DX: SLE, mixed connective tissue disorder, anemia of chronic disease Records reveal patient in good general health 12/2007, sexually active but urine protein 300+ (H). Started on Bactrim. RTC 1/3/08 w/fatigue. RTC 2/08 w/symetric nodular rash on arms & face x 1 wk w/mild itching & aches/pains x 6 mo. Dermatology, Rheumatology, Nephro & GYN consult done & dx w/SLE (ANA+, rash & proteinuria). Tx w/steroids & plaquenil. 10/24/08 Reviewed rheumatology clinic records of 4/1/08 & hospital medical records of 7/23-7/25/2008. No other records available. FINAL DX: mixed connective tissue disorder w/SLE Records reveal patient had initially been seen in rheumatology clinic on 3/18/08 & dx w/SLE. Tx w/steroids, plaquemil & ASA for rash & (+)ANA. Improved by 4/1 visit w/only minimal pain in distal fingertips. Had been seen by ophthalmology 3/22/08 & exam WNL. Exam on 4/1 revealed slightly enlarged but nontender inguinal lymph nodes, hyperpigmented plaques on face, upper arms, axillae, vasculitic rash on palms, plinter hemorrhages in distal fingermails. Dx at that time: SLE w/discoid rash, elevated muscl”

Total   1          1.35%

Total   1          1.35%

323263-1         Serious            Primary           1          1.35%  Information has been received from a medical assistant concerning a 15 year old female with allergy to CEFZIL and no relevant medical history who on an unspecified date was vaccinated with a dose of GARDASIL (lot number, injection site and route not reported). In November 2007, the patient experienced headaches, stomach ache, dizziness, shakiness, dull and sharp aches all over. The patient also experienced joint pain all over, swelling of the right thumb, depression and insomnia. The patient had been set up with an appointment with a rheumatologist. Laboratory tests (included unspecified lab work, MRI of brain and X-ray of right hand (results unspecified). At time of this report, the patient’s events persisted. According to the reporter, the patient’s events prevented her from school schedule and were considered to be disabling. Additional information has been requested. 10/22/08-records received-presented on 8/8/08 with C/O headache,stomach ache, dizzy and shaking on and off for a while. Generalized pain. Abdominal pain. DX gastritis. Dizziness. 8/18/08 continues with C/O headaches and body aches. DX: arthrlagias, polymyalgias. Swelling of right thumb. Cephalgia. Dep ression. Insomnia. 9/3/08 continues with cephalgia, myalgias and depression.10/1/08-C/O abdominal pain. 12/31/08-records received for DOS 11/10/08-C/O arthralgia/back pain left limb pain. Vitamin D deficiency.

Total   1          1.35%

Total   1          1.35%

323430-1         Serious            Primary           1          1.35%  Information has been received from a neurologist concerning a 21 year old female previously in good health who in March 2008, was vaccinated with the first dose of GARDASIL (lot# not provided). Concomitant medication included several other vaccinations (not including MENACTRA). Subsequently, the patient developed motor neuron disease consistent with amyotrophic lateral sclerosis (ALS). Her progressive clinical course began in April 2008. The patient had not received a second dose of GARDASIL or any other vaccines since onset of symptoms. She developed upper extremity weakness which had become generalized and much more severe. She had been hospitalized in intensive care for several weeks with respiratory failure. Her condition deteriorated despite treatment with immunoglobulin. She had upper and lower motor neuron features with fasciculations. There is no sensory loss. Diagnostic workup included cerebrospinal fluid analysis (CSF) and muscle biopsy that ruled out other conditions (such as Guillaine Barre) and clinical picture is consistent with amyotrophic lateral sclerosis. Antineuronal antibodies were pending. A Superoxide dismutase (SOD) was pending and Stathmin (SMN) test will be ordered if SOD was normal. The reporting physician did not believe that illness was related to GARDASIL. Additional information has been requested. This is one of several reports from the same source. 9/9/08 Autopsy states COD as unclassified neurologic process, clinically presumed to be atypical GBS vs bulbar varient of ALS. FINAL DX 8/17-8/21/08 admission: amyotrophic lateral sclerosis & death by respiratory collapse. Developed cough, difficulty breathing, difficulty swallowing, poor oral intake, constipation, lack of energy 6 days prior to admit; had received Depo-Provera & outpatient IVIG prior to admit w/o any improvement. Admitted to ICU. Gradually worsened over the hospital stay, had NGT for feeding but refused PEG tube placement or tracheostomy. Referred to hospice & expired. FINAL DX 7/28-8/1/2008 admission: axonal motor neuropathy vs neuro neuropathy. UE weakness had progressively worsened until unable to even brush her teeth. Had facial weakness, unable to lift arms above the head or off the bed, difficulty lifting LE off bed, poor neck flexion, ataxia, hyperreflexia, pain. Muscle biopsy done. Tx w/repeat IVIG. Improved & d/c to home w/outpatient neuro, PT/OT f/u. Neurology Clinic notes of 7/18 & 7/22/08 FINAL DX: Guillain Barre syndrome Records reveal patient experienced stable course s/p hospitalization except for weak voice, HA, tiredness, poor appetite. RTC 7/22 w/improved LE weakness but difficulty standing & marked UE & neck weakness. Very slow progress led to depression. Started on antidepressants. FINAL DX 7/2-7/7/08 admission: actonel motor neuropathy vs neuro neuropathy. Records reveal patient experienced weakness in approx 4/08 after having fall & hit her head. Approx 3 weeks after the fall, patient had severe muscle weakness whil

Total   1          1.35%

Total   1          1.35%

323677-1         Serious            Primary           1          1.35%  Information has been received from a registered nurse (R.N.) concerning a 17 year old female with no pertinent medical history or drug allergies who on 28-JUN-2007 was vaccinated intramuscularly with the first 0.5 ml dose of GARDASIL (lot #654535/0960F), on 29-AUG-2007, was vaccinated intramuscularly with the second 0.5 ml dose of GARDASIL (lot #654535/0960F) and on 21-DEC-2007, was vaccinated intramuscularly with the third 0.5 ml dose of GARDASIL (lot #657621/0387U). Concomitant therapy included MENACTRA. In January 2008, the patient complained of numbness, cold hands and feet, joint pain in ankles, knees and wrists. The patient was seen by a rheumatologist and in April 2008, and she was diagnosed with Raynaud’s lupus. Smith antigen antibodies test indicated positive. SM/RNP antibody was positive. The patient’s Raynaud’s lupus persisted. No product quality complaint was involved. Raynaud’s lupus was considered to be disabling due to numbness and joint pain. Additional information has been requested. 10/21/08 Reviewed rheumatology outpatient clinic records of 04/02-7/30/2008. FINAL DX: mixed connective tissue disease w/components of both lupus & RA Records reveal patient experienced color changes & numbness of hands/feet in cold weather; progressively worsening joint pain, swelling & stiffness since 1/08; fatigue; weakness; lymphadenopathy of neck, resolved; HA w/photophobia; nausea; weight loss following flu-like illness 1 mo prior; irregular periods on BCP. Tx w/plaquenil, nsaids, methotrexate & folic acid w/improvement. 9/9/06 Reviewed PCP medical records of 6/28/07-7/10/2008. FINAL DX: Records reveal patient experienced general good health on date of 1st HPV & menactra vaccination. RTC 10/2/07 w/fatigue, falling asleep inappropriately, runny nose, cough, ear pain & sore throat x 3 days; vomiting & diarrhea week before. Also complaining of numbness of hands. Exam revealed tender lymph nodes, reddened throat. Dx w/viral illness. RTC 10/19 w/continued c/o of exhaution, fatigued going up stairs, left side abdominal pain intermittently, sweating, occasional HA. Boyfriend had mono. RTC 12/21 for final HPV. C/O spotting few days prior to menses for past several cycles. RTC 1/25/08 w/pain in hands/feet, discoloration of hands, pins & needles, difficulty opening/closing hands, sweaty palms. Dx w/probably Raynaud’s. RTC 2/25 for hands turning purple when cold then white & painful. When warm, hands get red, sweaty & swollen. Also c/o facial acne. RTC 3/12 w/sore throat, vomiting, dizziness, HA, runny nose. Dx w/pharyngitis, probably viral. RTC 3/18 & 7/10 s/p labs, achy, hands numb in AM, sun sensitive. Dx w/probable connective tissue/autoimmune disorder. Encouraged to d/c oral contraceptiives & switch to IUD. Started on PLAQUENIL & referred to Rheum. Daily pain. Lupus. Rhuematoid arthritis. Aching muscles and bones.

Total   1          1.35%

Total   1          1.35%

323722-1         Serious            Primary           1          1.35%  Pt, a strong, athletic fourteen year old volleyball player received the GARDASIL vaccine at her pedatirician’s office on July 10, 2007. At that time she weighed approx 131 lbs. and had no other medical conditions other than a previously diagnosed thyroiditis (Hashimoto’s) treated with SYNTHROID 75 mcg. On the day of her visit to the pediatrician for a school and sports physical she received the GARDASIL along with the Hepatitis A vaccine because we were planning on traveling outside the country later in the year. She began her volleyball training a few weeks later and although she was keeping pace she often complained of exhaustion. Because the training was vigorous, no one thought of it. School began in late August and she continued a vigorous regiment. By mid September she was complaining of back muscle pain which we thought was simply from playing. She had also begun complaining of stomach pains. By the first of October there was a marked difference in her stamina and the pain and obvious muscle weakness became more obvious. As a player who could easily seven ten to fifteen hard serves in a row during a game, she could barely put two or three serves over the net. In mid October she was seen by her pediatrician who could find nothing medically wrong with her. But by the end of October, she could barely carry her book bag in school and could barely walk the hallways during a full day of school. She was seen by her endocrinologist during the first week of November for her regular check up and this exhaustion was brought up. Lab work done revealed that if there was something wrong, it was not due to her thyroid which was functioning normally. Two weeks later she was seen again by her pediatrician, again nothing was diagnosed. Another week later she was seen again and lab work was done to rule out Strep and mononucleosis. Seven days later we were told her mono titer was positive so everyone assumed that was the cause for her fatigue. After days of bed rest, no real improvement was noted. Three weeks later, she was

Total   1          1.35%

Total   1          1.35%

323865-1         Serious            Primary           1          1.35%  “In December of 2007 and January of 2008, patient became withdrawn and concerned that she did not lose weight despite diet and exercise, and she started having opsoclonus. She had no illnesses around the time of onset of those symptoms. Brother had been quite ill (thought initially to be meningitis, but turned out to be unknown) and is now better. She had a meningitis vaccine and HPV vaccine at the time that she started to be withdrawn. Over the course of 1-2 weeks she became ataxic, and had very “”jumpy arms”“. This myoclonus spread to her legs such that she could not walk. She denied headaches, nausea, and or vomiting. No muscle aches or leg pain. No tinnitus or hearing loss. At the time of a February 11, 2008 admission she had severe opsoclonus, myoclonus, dysmetria, and perhaps a wide amplitude tremor. An extended evaluation was started looking for a neuroblatoma and a ganglioneuromal, mitochondrial disease, inflammatory diseases, and other diseases. There were a few abnormal lab results, which normalized later. The lactate normalized only after starting mitochondrial vitamins. No evidence of a ganglioneuroma or neuroblastoma was found. Blood mitochondrial mutations were sent and later returned as normal. Because the lactate was high, we added Thiamine 25 mg twice daily and riboflavin 50mg twice daily, CoQ, and Keppra was started later at 1mg/kg/day, and advanced as tolerated, then lowered when she started feeling nauseated. She received steroid x 1 week courses, with marked hyperglycemia, but no improvement. She received IVIG, then sent to hospital. She was discharged from hospital with improved opsoclonus, but still unable to walk or reach easily. She returned to hospital for a second course of IVIG. After that, the mitochondrial meds were stopped, she remained unable to walk, and had variable but usually less opsoclonus. Physical therapists noted some weakness and atrophy, and she had one episode when she would fall to the left side when the tuning fork was put near her left ear. She had had no convulsions and had a normal EEGs, including a normal 24 hour EEG; no emesis; no headache; no deterioration of affect or bizarre behavior. She has had no trouble eating and she can use a fork, but has some difficulty using her knife to cut. She was seen by doctor, who, mother says, gave a cursory exam, stated that patient’s strength was adequate to walk, and that Mother should stand her up, make her walk, and she will be walking in several months. 12/1/08 MR received for 2 admissions: DOS 2/11-29/2008 with D/C DX: Post-infectious myoclonus and opsoclonus with lower extremity weakness. Depression. DOS: 4/17-19/2008 with D/C DX: Upper extremity weakness. Opsoclonus-myoclonus. Two months prior to admission pt noticed new onset of mood changes-depression and anger. One month prior pt noticed abnormal eye movements which resulted in vertigo. Pt presented with worsening eye movements with dizziness and shakiness. Unable to wa

Total   1          1.35%

Total   1          1.35%

324169-1         Serious            Primary           1          1.35%  Headache, seizures, fever, dizziness, lupus like syndrome; Started – approximately 4 months after last injection, patient hospitalized several times placed in intensive care unit 11/17/08 records received-for DOS 7/27/08-admitted via ED for C/O abdominal pain for 5 days, no bowel movement in 5 days. Seen by PCP on 7/24/08 with no diagnosis. Seen 2 days prior in ED with negative workup. Signed out AMA. Notes for DOS 8/18/08-DX-Drug-induced lupus, questionable. Possible underlying systemic lupus. Viral syndrome, questionable viral encephalitis. Inflammatory renal disease. Myalgias with possible peripheral neuropathy. Possible reaction to vaccination. Anemia. Elevated erythrocyte sedimentation rate suggesting underlying inflammatory disease. Abdominal pain possibly secondary to renal inflammation. Presented with C/O abdominal pain, intermittent joint and neck pain and headache.Records for 8/30-9/02/08 DC DX: new-onset seizure activity. Possible benign vasculitis to inflammatory vasculitis. Possible cerebral infarct evolving nature with edema involving multiple areas of brain as per MRI. History of lupus positivity possibly drug induced lupus. Questionable viral meningitis with negative CSF. Generalized pain and fatigue. Peripheral neuropathy. Possible meningitis inflammatory nature. Renal failure with reversal. Normal creatinine. Transferred.12/8/08-records received for DOS 9/2-9/12/08-DC DX:PRES. Hypertensive Disorder. Presented with 2 month history of headahces, joint pains, and abdominal pain. Presented to ED 3 days prior with severe headache, vomiting and multiple generalized tonic clonic seizures. Headaches began end of June and diagnosed with sinusitis. Subsequently developed leg aches, wrist aches, joint stiffness and mild rash on legs. Extreme headache, double vision vomiting. Symptoms improved but developed severe stomach pains and constipation. Improved with Prednisone but symptoms began after Prednisone taper. Rheumatology thinks this is a vasculitis secondary to OCPs. Ophthalmology mild esophoria visib

Total   1          1.35%

Total   1          1.35%

325671-1         Serious            Primary           1          1.35%  PT HAD THE SECOND GARDASIL INJECTION IN SEPT ’07. AND THE FOLLOWING MONTH SHE STARTED HAVING HEADACHES, ABOUT 3XS A WEEK. THEN IT GRADUALLY INCREASED SOME WORSE THAN OTHERS. FINALLY ON JANUARY 1 ’08, SHE HAD A SEVERE MIGRAINE. THAT INCAPACITATED HER FOR AN ENTIRE 2 DAYS. THE PAIN WENT ON FOR A WEEK THEN SHE BEGAN TO GET HEART PALPS. THEN AFTER GIVING HER MEDICINE FOR THE MIGRAINE. SHE HAD A SEIZURE ONE NIGHT. SHE WAS TAKEN TO THE E.R. BY AMBULANCE AND WAS ADMITTED FOR A DAY AND A HALF. IN ORDER TO GET CONTROL OF THE HEAD PAIN WHICH BY THIS TIME HAD BEEN CONSTANT FOR ABOUT 3WKS. FINALLY THE HOSPITAL WAS ABLE TO GET RID OF THE HEADACHE. BUT THE SAME DAY SHE WAS RELEASED WE HAD TO RETURN BECAUSE THE PAIN RETURNED WORSE. SHE WAS GIVEN PAIN MEDS I.V. AND SENT HOME. WE TRIED VARIOUS MIGRAINE MEDS AND NOTHING WORKED FOR LONG. THEN WE SAW A NEUROLOGIST WHO TREATED HER FOR ABOUT 2MNTHS. SHE HAD A COUPLE MORE SEIZURES BETWEEN THAT TIME, AND THE NEUROLOGIST ADMITTED HER AGAIN. TO START THE I.V. PAIN MED. SHE WAS ADMITTED FOR 2DYS THEN. FINALLY HAD SOME RELIEF FOR THE FIRST TIME IN A MNTH SINCE THE LAST ADMISSION. THAT LASTED 2DYS AND THEN THE PAIN RETURNED. AND HER SEIZURES INCREASED. SHE MISSED A LOT OF SCHOOL, WAS NOT ABLE TO PLAY OR CONCENTRATE. SHE LIVED IN CONSTANT FEAR OF FALLING OUT AND HAVING INCREASED HEART PALPS. SHE HAD BOUTS OF BIGEMENY ALSO. THIS HAS GONE ON SINCE THE 2ND SHOT OF THAT GARDASIL. SHE HAS NEVER TAKEN MORE THAN TYLENOL FOR PAIN ALL HER LIFE. VERY ACTIVE, FUN KID. BUT FOR MONTHS SHE HAD BEEN STRUGGLING WITH THIS. I FOLLOWED THE REPORTS ON THIS DRUG WHICH LEAD ME TO CONTACT SOMEONE ABOUT THIS. THEN DIFFERENT PEOPLE I SPEAK WITH IN DR OFFICES HAVE HAD FAMILY MEMBERS ALSO HAVE BAD REACTIONS, ALSO THE MORNING NEWS CLIP ABOUT HOW SOME OTHER YOUNG GIRLS HAD BAD REACTIONS. NOW SHE IS GETTING BETTER (PROBALLY BECAUSE SHE DID NOT HAVE THE 3RD INJECTION). BUT EVEN NOW THINGS ARE HARD FOR HER. SHE HAS REALLY BAD MIGRAINES NOW WHICH WAS NEVER AN ISSUE, AND SHE GETS TIRED EASIER NOW, MUCH EASIER. I WOULD LIKE SOME ANSWERS ABOUT THIS.MY CHILD HAS SUFFERED AND IS SUFFERING. I REALLY WOULD LIKE SOME ANSWERS PLEASE. 9/22/2008 ER record received for DOS 2/26/2008 with DX: Status Migrainosus. Pt reported for DHE tx for 4-8 wk hx of L temporal and occipital migraine pain. Pt trialed multiple meds w/o relief. Had some relief from 1 previous dose of DHE. 09/23/2008 MR received from neurologist for OVs beginning 1/28/08-3/18/08 with initial dx migraine H/As. Seizure-like episodes. Status migrainosus Pt initially presented following 2 ER visits-one for severe H/A, another for seizure episodes which include drooling, stiffening, shaking of extremities, and eye deviation with post-ictal state. Headaches include photophobia, phonophobia, nausea and vomiting as well as some dizziness and double vision. PEs WNL. Seen 3/18/08 with recent seizure like episode. Anticonvulsants increased. 9/26/08 MR received for multiple ER visits and one admission d

Total   1          1.35%

Total   1          1.35%

325672-1         Not Serious     Primary           1          1.35%  Severe joint pain, knee’s, elbow, TMJ, missed periods. Pt has seen an oral surgeon and is now being treated by a TMJ specialist as well as a Rheumatologist to try to figure out what is going on. All these issues started after the vaccinations began. 9/29/2008 PCP records received from 1/7/2008 to present. 16 yr WCC with normal exam 1/7/08. Seen 3/21/08 for URI sx, head pressure, tooth pain, feeling faint, and vaginal d/c. Assessment: vaginitis. sinusitis. Seen 6/23/08 for c/o knee pain R>L x 2 weeks with no injury. PE WNL. F/U 8/8/08 with joint pain in elbows, knees and cracking shoulder. Hurts to swallow. Diminished energy over past few months. Weight loss. Assess: Wt loss, joint aches and pains, increasing over past 2-3 months. ? rheum issue or r/t Topamax. Will refer to Rheum.

Total   1          1.35%

Total   1          1.35%

326140-1         Not Serious     Primary           1          1.35%  Information has been received from a physician concerning a 15 year old female with a cough and history of migraine who on 30-JUN-2008 was vaccinated with the first dose GARDASIL vaccine (yeast) (Lot number 660555/0279X). There was no concomitant medication. On 07-JUL-2008, seven day later, she was diagnosed with iritis. She was seen by an ophthalmologist and received an unnamed treatment. She was also scheduled to see a rheumatologist. She had a cough before receiving GARDASIL vaccine (yeast) and still had the cough. At the time for this reporting, the patient’s iritis persisted. Additional information has been requested. 1/12/2009 MR received from 7/10/08-11/25/08 with DX: Chronic anterior uveitis, both eyes, without uveitic complications. Hx of migraine episodes. Sinus disease. Chronic cough. Elevated CRP and ESR. Proteinuria. Pt initially presented 7/10/08 with c/o 1 wk hx of intermittent blurred vision of the L eye and 3 week hx of cough. PE (+) for conjunctival injection with 2+ cells in anterior chamber. Impression: Acute Iritis OS of unknown etiology. Early myopia. F/U 7/16/2008 now bilateral Iritis. Consult 8/19/08 with another ophth. Referred for eval and mgmt of uveitis, both eyes due to little response to previous tx with topical steroid. ? TINU (Tubulo-interstitial nephritis and uveitis) being considered 2′ to proteinuria. 2/2/09 MR received from rheumatology and nephrology consults. Seen 7/16/08 with c/o blurry eyes, decreased vision, red eyes, recent chest pain and cough and congestion. PE (+) for mild scoliosis. DX: Iritis. Cough and congestion. Wegener’s Granulomatosis. Increased Sed rate, (+) ANA. Mild scoliosis. Proteinuria. F/U visit Dx changed to Likely TINU-Tubulo-interstitial nephritis: mild uveitis and nephritis. Hemangioma T4 spinal vertebra. Sinusitis. Seasonal allergies. Now c/o back pain-lower back and T12 to L1-4. Referred to nephrology for proteinuria. Uveitis slowly improving with steroid drops. Proteinuria resolved.

Total   1          1.35%

Total   1          1.35%

326479-1         Serious            Primary           1          1.35%  “Information has been received from a physician’s nurse concerning a 14 year old female who on 10-MAR-2008 was vaccinated with the third dose of GARDASIL vaccine (yeast) (Lot # 659435/1265U). There was no concomitant medication. The reporter heard that the patient was very sick and had an autoimmune disorder. It was unclear if the patient was hospitalized. The physician in the case had not been contacted by the patient’s mother at the time of the report. The patient’s autoimmune disorder persisted. The patient sought unspecified medical attention. Additional information has been requested. In follow-up a physician reported that the patient had several months pf heaby periods, developed rectal bleeding and bruising. The patient was diagnosed with idiopathic thrombocytopenic purpura and ulcerative colitis. It was also reported the patient developed an unspecified auto-immune disease. She received two units of packed red blood cells and multiple treatments with REMICADE and globulin, immune. The patient required emergency room visit and was hospitalized for 3 days. It was unknown if the patient recovered. It was noted that the patient continued on “”aspirin cd”” and oral conctraceptives. In follow-up a physician reported that the patient was diagnosed with autoimmune disorder. The specialist that the patient was seeing and the reporting physician did not feel that GARDASIL vaccine had anything to did the patient’s condition. No further information is available since the physician stated that he already completed the forms and doesn’t wish to receive anymore forms. 10/20/08-records received-4/30/08-C/O irregular and excessive menstruation. Pt got her period for first time in December and skipped 3 months until April. Presented to ED on 5/10-5/13/08- DC DX: ITP and GI bleed. C/O feeling tired, weak, fever spiked to 102.2 nasal congestion, cough, sore throat. Petechial rash. Bloody stool 2 days ago. Weight loss.”

Total   1          1.35%

Total   1          1.35%

329112-1         Not Serious     Primary           1          1.35%  Information has been received from a physician for the pregnancy registry for GARDASIL concerning a 26 year old female who on an unspecified date was inadvertently vaccinated with GARDASIL while pregnant. After the patient received GARDASIL, she had a spontaneous termination at 6 weeks and 5 days from the last menstrual period. The patient had FYA antibodies (noted to be abnormal antibodies indicative of an autoimmune disorder). She was antinuclear antibodies test (ANA) negative with this second termination. the patient was not hospitalized. Subsequently the patient recovered. She had dilation and curettage (D & C) following the spontaneous termination. The reporter didn’t necessarily think it was linked but she could not understand the connection to GARDASIL, and she could not find any other reason for the termination. Upon internal review the patient’s spontaneous termination was determined to be an other important medical event. The patient also had a first spontaneous termination after the vaccination at 13 weeks from the last menstrual period. (WAES# 0810USA01794) Additional information has been requested.

Total   1          1.35%

Total   1          1.35%

329114-1         Not Serious   Primary           1          1.35%  Information has been received from a physician for the pregnancy registry for GARDASIL concerning a 26 year old female who on an unspecified date was inadvertently vaccinated with GARDASIL while pregnant. After the patient received GARDASIL, she had a spontaneous termination at 13 weeks from the last menstrual period. The patient had FYA antibodies (noted to be abnormal antibodies indicative of an autoimmune disorder). She was antinuclear antibodies test (ANA) positive with the first termination. The patient was not hospitalized. Subsequently the patient recovered. She had dilation and curettage (D &C) following the spontaneous termination. The reporter didn’t necessarily think it was linked but she could not understand the connection to GARDASIL, and she could not find any other reason for the termination. Upon internal review the patient’s spontaneous termination was determined to be an other important medical event. The patient also had a second spontaneous termination after the vaccination at 6 weeks and 5 days from the last menstrual period. (WAES# 0810USA02664). Additional information has been requested.

Total   1          1.35%

Total   1          1.35%

331142-1         Serious          Primary          1          1.35% Patient developed arthralgias, change in mental status. Diagnosed with Systemic Lupus Erythematous on 10/23, based on +ANA and +dsDNA. Admitted to Hospital for changes in mental status, thought to be from lupus cerebritis. records received 11/14/08-presented to ED 10/28/08-C/O short term retrograde amnesia. Intermittent blurry vision. C/O joint pain, headaches nausea for 4 weeks. Left hand weakness. One and half months prior C/O pain in hands and feet, isolated papules. Difficulty sleeping. 12/1/08-DC summary received for DOS 10/28-11/6/08-DX:Lupus cerebritis. Change in mental status.

Total   1          1.35%

Total   1          1.35%

334377-1         Not Serious     Primary           1          1.35%  Nonspecific autoimmune/connective tissue disorder with joint pain, diagnosed after vaccine given. 3/9/09 Received Lupus consult medical records of 4/10/07-2/16/2009. FINAL DX: SLE; Raynaud phenonmenon; anticardiolipin antibodies; mild alopecia Records reveal patient experienced acute onset polyarthralgias in 10/06 3 days after HPV vaccine & lasted approx 4-6 wks. Had been referred to Rheum. Had scaly rash over elbows & knees. Had recurrence of polyarthralgias, stiffness & ankle swelling 2/2008. Had episode of vaginal ulcer x 1 in 4/2008 which was neg for herpes. No history of oral herpes. 5/2008 found to have polyclonal gammopathy & started on plaquenil w/great improvement. Had developed another vaginal sore thought to be psoriasis. BCP & acne meds d/c 2/09 when found to have pathologic antibody & started on lose dose ASA.

Total   1          1.35%

Total   1          1.35%

334846-1         Serious            Primary           1          1.35%  “Information has been received from an employee concerning a 16 year old female, who on 25-SEP-2008 was vaccinated with GARDASIL (1st dose). The patient never had any psychiatric event, athlete (she plays sand volleyball), does not use to get out at night, studding the 2nd year of high school. Anybody in the family has a history of psychiatric disease or had taken anytime drugs for this condition. Her family begins to notice that the patient was very thirsty (she drunk 31 or more daily), very high anxiety and euphoria approximately 15 days before the outbreak (09-OCT-2008). She used to write happiness notes to her mother, talk about everything with her eyes widened-she gave the impression that “”there is no one so happy than me””. Her family begins to be surprised, but didn’t think that I was something important or severe. On 23-OCT-2008, the patient left school and come back to her home because she had a malaise. On 23 and 24-OCT-2008, she had a very severe insomnia (she slept very little time and woke up thereafter with a peculiar anxiety). Insomnia was higher at the day- break between days 24 and 25-OCT-2008. In the morning of day 25-OCT-2008, from the morning until afternoon the patient was loosing her control, very agitated and anxious- she beat in her relatives, asked for a beer, asked for a knife, she throw out to a window (that had a rail), she told that she was going to materialize with the sofa (hallucinations), much anxiety. The reporter compared the patient’s behavior with the character of the movie “”exorcist””. Starting in the morning, during the afternoon the picture was more intense, the pictures appeared and the patient was uncontrollable. At night, the psychiatrist was called who prescribed EUTONIS, performed a sub-valuation, stating that “”it was a very small crisis, with no importance””. The patient took a tablet that had no effect, and the physician ordered to take a second one, which she took, but without any effect. The patient nodded (sometimes for 5-10 minutes), when she arouses she didn’t disti”

Total   1          1.35%

Total   1          1.35%

336933-1         Not Serious     Primary           1          1.35%  HAD THE SERIES OF 3 GARDISIL VACCINES, HAVE BEEN EXPERIENCING PAIN IN FEET, HANDS, THEN OTHER JOINTS, BEEN TO DOCTORS, JUST BEEN TOLD MAY HAVE RHEUMATOID ARTHRITIS!! AT AGE 28. THESE SYMPTOMS STARTED AFTER THE VACCINE,BUT HAVE WORSENED OVER LAS 9-12 MONTHS!! I THNIK IT IS FROM THIS VACCINE! WHAT CAN WE DO? DON’T WANT MY DAUGHTER TAKING RA MEDS IF SOMETHING ELSE CAN HELP!! 2/2/09 Rheumatology consult received for eval of joint pain dated 12/19/08. Pt initially c/o sore feet, particularly in MTP joints x 2 yrs. Hand pain x 1 yr. Recent hand swelling jaw pain, and R shoulder, elbow and wrist pain with morning stiffness x 30 minutes. (+) canker sores and fever blisters. PE (+) for L posterior cervical lymph node, decreased thumb flexion, joint tenderness, synovitis, and swelling. Presntation c/w inflammatory arthritis such as RA.

Total   1          1.35%

Total   1          1.35%

337963-1         Serious            Primary           1          1.35%  Soon after Gardasil, pt developed fever, malaise, confusion. Admitted to hospital and Dx’d with ADEM vs. cerebral vasculitis. Has made nearly full recovery. Question of Gardasil-induced vasculitis or immune-related acute CNS/systemic disorder. 3/3/09 MR received for DOS 9/25-29/2008 with D/C DX: ACute intracranial process, possible immunization related vs vasculitis vs diffuse encephalomyelitis. Recent Gardasil vaccination-uncertain relationship to this event. Leukocytosis-most likely r/t steroids. Mild hyponatremia during hospitalization. Hyperglycemia 2′ to steroid use. Pt presented with c/o 1 1/2 wk hx fevers, weakness and altered mental status. Several ER visits prior to this admission. Pt reports sore throat, tiredness, fatigue, H/A, increased HR and bilateral foot numbness. Pt tx with steroids and d/c for outpt f/u.

Total   1          1.35%

Total   1          1.35%

338733-1         Serious            Primary           1          1.35%  “February 2008 first shot experienced headaches, dizziness, back pain, soreness at injection site (still feels pain in arm today). April 2008 after second infection in addition to above symptoms, confustion, lethargic, gagging, nausea, vomiting, massive warts on the bottom of feet, mood swings, altered personality, shaking. In May 2008 was brought to the hospital had a MRI and cat-scan both normal. The doctor said she was experiencing headaches. In June 2008 she woke up with a headache and vomiting, collasped into a grand-mal seizure. Tranferred to a hosptal. Went through every test possible and came home for a few days. Went into another grand-mal seizure that lasted about three hours, had to be intabated again and transported to the hospital again where they did another MRI, EEG, Spinal Tap and more and more blood tests. Her protein level in her Spinal Tap was very high (159). We are still dealing with a very ill child. On Christmas day she had a seizure and back to hospital which is two and a half hours away from where we live. She takes 14 pills a day with really no answers to why she is ill. Her immune system is confused, confusing her brain. Her life has changed dramatically as she is unable to do the things a healthy 17 year old should be able to do. 2/17/09 Neuro consult dated 1/2/09 received with dx: probable Hashimoto’s Encephalopathy. Report reveals pt had 2 prolonged seizures in summer 2008 with behavioral and mood changes. Dx with Hashimoto’s Encephalopathy and tx with steroids x 3 mon which were tapered off. On 12/25/09 pt woke feeling nauseous and gagging, tremoulous, and feeling sick. Felt like face “”was pulling off””. Unable to yell or move. Found by parents seizing ~ 10 minutes. Diastat administered. Transferred to hospital. Post-ictal then later combative and agitative. Pt reports being tired and achey since 11/08. Neuro exam WNL. 3/19/09 Additional records received from 7/23/08, 8/26/08 and 2/20/09 Neuro consults as well as rheum consult 2/20/20009 as well. Pt hospitalized in June”

Total   1          1.35%

Total   1          1.35%

341435-1         Not Serious     Primary           1          1.35%  None Stated 3/18/09-records received-office visit office visiti 12/5/08-positive ANA, fatigue and arthralgias. October had asthma flare that required steroids and never really recovered from it. Diagnoses with mycoplasma pneumonia. Since then felt exhausted and could not catch breath. Mother had similar symptoms. Hand pain. 2/20/08-ANA positive inflammatory polyarthralgias, follow-up visit since 2 months prior. C/O pain in bilateral hands and feet. No consistent joint swelling. Fatigue, all over body pain, inability to do activities like ski. Assessment:undifferentiated connective tissue dosorder suggestive of fibromyalgia. 3/5/08-swollen lips and tingling after opening new bottle of shampoo.

Total   1          1.35%

Total   1          1.35%

341864-1         Not Serious     Primary           1          1.35%  Fatigue, joint pain after immunization until 3/08.

Total   1          1.35%

Total   1          1.35%

343922-1         Serious            Primary           1          1.35%  within 20 mins of injections, pain, stiffness, extreme fatigue, lethargic . Then experienced cont. pain and soreness, stiffness on and off for next week and 1/2 when became increasingly worse with joints locking up, severe pain and stiffness, fatigue, fever, swelling of joints. Small relief with pain meds. 4/29/009 Received PCP medical records of 8/25/08-4/8/2009. FINAL DX: polyarticular arthralgias Records reveal patient experienced good general health & was on OCP on 3/23/09 for HPV#1 & Menactra. RTC 4/8 & reported malaise since day after vax & then developed progressively worsening joint pain, stiffness & swelling w/difficulty sleeping & generalized body aching x 1 wk. Tx w/NSAIDS & heat. Patient still has pain in the joints and stiffness in the joints at times. We would not make the same decision, if we had it to do over again.

Total   1          1.35%

Total   1          1.35%

344938-1         Serious          Primary           1          1.35%  autoimmune disease fibromyalgia, raynods, numbness, flushing/sweats, anxiety,headaches, exhaustion to the point where its impossible to work, total body pain constantly,hair loss, vision problems,stiff and sore muscles,insomnia, trouble focusing and concentrating, memory loss, weakness, trouble breathing,and dizziness near syncope. All the side effects happened and intensified during December through January so I had an anti nuclear antibody blood test that was positive revealing the autoimmune disease fibromyalgia and raynods. My ANA blood test has come back positive several times. The doctors put me through a ridiculous amount of tests to try to figure out a diagnosis and why this had come out of nowhere. They thought I had at one point every different type of autoimmune disease including lupus but settled on FIbromyalgia with raynods and the possible beginnings of Lupus. I have to frequent a rheumatologist, neurologist,and primary care doctor several times a month. The side effects have made me very weak and unable to live my life normally, its hard for me to work. I teach children which take a lot of energy when I have none what so ever. I used to be strong and able to work out and ride horses and live a healthy active lifestyle, now I cannot enjoy any of it. My body is in such pain all the time that its impossible for me to have a normal life. I wanted this vaccine to help prevent problems, when all it did was destroy my life. 5/18/09 Vax info received. HPV#1 7/7/08 0847X. HPV#2 9/8/08 0546X. HPV#3 1/7/09 0546X. 7/15/09 Rheumatology consult rec’d dated 1/29/09 to 6/8/09 with final dx: Inflammatory arthritis, arthralgias. Pt presented with c/o numbness and bluish discoloration of the feet. Pt also has a blackish scab on the R 3rd toe. Pt reports feeling achy all over. PE (+) for cold fingers and toes and bluish discoloration of toes. (+) fibromyalgia tender points. Assess: Raynaud’s. ANA (+). Scoliosis. Possible fibromyalgia. F/U 3/5/09 with dx: fibromyalgia. Pt reporting poor sleep

Total   1          1.35%

Total   1          1.35%

345222-1         Serious            Primary           1          1.35%  Information has been received from an office nurse concerning a female who on an unknown date, was vaccinated with the third dose of GARDASIL (lot# not reported). Subsequently the patient was diagnosed with Guillain Barre by a neurologist. Upon internal review, Guillain Barre was considered to be an other important medical event. In follow-up, the nurse revealed that the approximately 22 year old patient received two doses of GARDASIL on 18-JUL-2007 (lot# 658100/0525U) and 20-DEC-2007 (lot# 659439/1267U). Additional information has been requested. 8/26/09 MR rec’d for DOS 5/6-12/2008 with D/C DX: Guillain-Barre Syndome, s/p 5 days of IVIG. ADHD. Pt initially presented to ER with 9 day hx of ascending numbness and weakness to the level of the abdomen. 2 prior ER visits, but presented again with chest pressure, decreased strength, difficulty walking, and worry re: condition. PE (+) for decreased strength and sensation. DTRs trace or absent. Admitted for IVIG. Pt had autonomic instability with tachycardia and HTN, insomnia, H/A and constipation, somewhat improved by d/c. Transferred for rehab 5/12/08 ICD9-357.0, 787.20, 349.0,314.01, 9/4/09 Hospital records received DOS 5/23/08 to 6/9/08. Assessment: Guillain-Barre’ Syndrome Previous hospital stay complicated by respiratory distress / insufficiency. Transferred and placed on respiratory support (BiPAP). 7 days of plasmapheresis. Dysphagia, PEG tube. Difficulty activating facial muscles. Decreased muscle strength. Deep tendon reflexes absent lower extremities, trace in upper extremities. Anemia. Headache. Discharge to rehabilitation.

Total   1          1.35%

Total   1          1.35%

349322-1         Not Serious     Primary           1          1.35%  Information has been received from a nurse practitioner concerning a 16 year old female who was vaccinated with the first dose of GARDASIL on 02-Aug-2007, second dose on 02-Oct-2007, and third dose on 20-Mar-2008. The patient did not receive any concomitant vaccinations when the GARDASIL vaccinations were administered. In approximately November 2007, the patient began to have signs and symptoms of Adrenal Insufficiency. The patient had sought medical attention. At the time of reporting, the outcome of adrenal insufficiency was unknown. Additional information has been requested.

Total   1          1.35%

Total   1          1.35%

350284-1         Serious            Primary           1          1.35%  Immediately following vaccine, patient began to complain of mild symptoms (my shoulder hurts, my wrist hurts, look at these spots on my leg. On the 5th of January, she came home from school with pain in both of her ankles but after resting and and Advil, she felt ok to go school. She came home from school on the 6th screaming in pain. Her ankles were so swollen, we had a lot of trouble getting her boots off. She couldn’t walk and had a rash all over her legs and ankles. We saw a pediatrician who immediately sent us to hospital. She had lots of tests and IV steroids and antibiotics. They later diagnosed her with Lupus. PCP records received as well as note from admission DOS 7/7-12/2009. Pt initially presented Jan 8, 2008 with c/o 5 day hx of bilateral ankle pain and rash of the ankle, calf and thigh. Seen in ER with PE (+) for petechial purpuric rash and low grade fever. Tx with abx and steroids and d/c for outpt f/u. Rheum consult PE (+) for L ankle effusion and decreased ROM. R ankle (+) for synovial thickening. Scant petechial lesions on LEs. ? Gardasil trigger for autoimmune disease with arthritis. F/U 1/15/09 with dx: Lupus. F/U 2/19/09, 4/6/09 with Impression: The presence of anti-histone AB suggests drug-induced Lupus 2′ to Gardasil. F/U 6/22/09 with c/o H/A, joint pain, mouth sores and rash. Assess: Worsening Lupus now with nephritis. Admitted 7/7-12/09 with D/C DX: Lupus cerebritis, lupus glomerulonephritis for c/o difficulty with word finding and increasing clumsiness. Nephrology consult for hematuria and proteinuria. 7/31/09 Hospital discharge summary received DOS 7/7/09 to 7/12/09. Assessment: Lupus cerebritis, lupus glomerulonephritis. Patient presented with 6 days of increasing difficulty finding words and general confusion. Choreiform movements and difficulty with memory. Palmar peeling after Cytoxan treatment. Papules on tongue. Malar rash. ICD-9: Diagnosis 710.0 Systemic lupus erythematosus Other causes of encephalitis and encephalomyelitis: 323.814,

Total   1          1.35%

Total   1          1.35%

353201-1         Serious            Primary           1          1.35%  48 hours after the vacination of Gardasil, I has a reaction. My legs swelled and I had small red bumps all over my legs. I couldn’t walk because of the pain and large amout of swelling in my knees and ankles. About 8 days after I had severe abdominal pain with vomiting and fever. I went to the doctor about a week after the shot because my legs were swelling all over and so were my elbows. The dots were spreading and they stung. She looked and examined me and we concluded I had HSP. It’s an autoimmune desease that causes the blood veins to pop and leak. It is supposed to go away after 4-8 weeks. I have had it since Sep. 11th of 2008. We went to a skin doctor to make sure and he took a biopsy of my leg in 2 places and it was in fact HSP. About a month or 2 after we found out what I had, we started noticing I got sick very easily. I had my blood and urine tested and the doctors saw that I had an extremely high level of protein and blood in my urine. In the blood they took they saw that my iron was low and I had a low white blood cell count. We kept testing one or twice every 2 or 3 weeks. The protien and blood went up and down but was never at a normal or healthy amount. We then went to a doctor. He looked at my urine and blood and decided to preform a kidney biopsy. He saw that I had scarring on my kidneys and found that I have an IgA protien that causes my kidneys to overwork. I was put on blood pressure medicine and bottomed out so we stopped that. We are still to this day trying to find out what to do about the situation. We’ve also been to an allergist. She saw that the ingredients in Gardasil along with the protien in my body are reacting. I can’t take any medication because I might have a reaction. Plus it goes to my kidneys which could cause damage. I might be put on steroids but we aren’t sure. I just hope more people know about Gardasil before someone else gets what I have or worse. 8/17/09 PCP medical records received DOS 8/12/08 to 7/13/09. Assessment: Henoch-Schoenlein Purpura. Patient presents wit

Total   1          1.35%

Total   1          1.35%

353275-1         Serious            Primary           1          1.35%  “Information has been received from a consumer concerning her 16 year old daughter allergy to cinnamon and with a history of an allergic reaction (eye redness) to neomycin (manufacturer unknown) who in August 2007, was vaccinated with first 0.5mL dose of GARDASIL (route and lot number not reported). There was no concomitant medication. After a couple of days the patient experienced severe joint pain that she could not get up from bed and was unable to walk. Patient was given steroid injection in her feet and knees and for almost a year she was in wheel chair. The patient was given the second dose of GARDASIL (route and lot number not reported) in August 2008 and in November 2008, she was diagnosed with “”polyarticular JIAR (Rheumatoid arthritis)””. The patient’s mother also stated that her daughter had abnormal cervical cells and small vaginal lesion. The patient’s mother stated that soon her daughter will be getting steroid injection on her hands because she is unable to lift them. At the time of reporting the patient had not recovered from the events. Upon internal review polyarticular JIARS+ (Rheumatoid arthritis) and unable to walk were considered to be disabling. Additional information has been requested. 8/24/09 Consultant records received DOS 8/20/08 to 8/4/09. Assessment: Enthesopathy, amplified musculoskeletal pain. Polyarticular JIA RF(+). Patient with acquired acanthosis nigrans and obesity presents with knee, foot and neck pain. ‘Walks like a duck’. Feet swollen. Nighttime awakenings secondary to pain. Stressed. Enthesitis multiple sites lower extremities and back. Torn medial menisc knee. Joint effusion. Anemia. Moodiness, anger and bruising. Joint stiffness. Feet turn blue. Wheezing. Pneumonia. Shoulder pain. Limp.”

Total   1          1.35%

Total   1          1.35%

354639-1         Serious            Primary           1          1.35%  Fatigue, dry skin, extreme fatigue, light headed, headache, increased menstrual cramps, Raynaud’s disease, weight loss, hair loss, joint pain, facial rash, extreme joint pain, body rash. 9/16/09 Rheumatology records received DOS 4/28/09 to 9/9/09. Assesment: Systemic Lupus Erythematosus. Vitiligo. Patient presented with progressive fatigue and weight loss with impaired functional capacity. Joint pain, swelling, and stiffness at PIPs, MCPs and wristes. Malar rash and Raynauds of feet. Leukopenia, anemia. Inflammatory polyarthropathy.

Total   1          1.35%

Total   1          1.35%

354967-1         Serious            Primary           1          1.35%  “Light-headed, dizzy, and nauseous immediately after vaccination. Since vaccination: headache, severe fatigue, numbness/tingling in extremities, sharp lower back pain, shoulder pain, hair-loss, memory ‘fog’/concentration difficulties, breathing problems, muscle twitching, leg/arm cramping, insomnia, rapid heart beat, overall soreness, GI problems. 9/28/09 Neurology consult received DOS 2/13/08 to 6/6/2008 Assessment: Fibromyalgia. Restless leg syndrome. Patient presents with chronic lower back pain and paresthesias. Developed numbness and tingling “”pins and needles”” affecting anterior thighs/lower extremities and upper extremities, also including left hand. Gait affected, using wheelchair. Decreased sensation to light touch, pinprick and vibration right upper and lower extremities. Reflexes asymmetrical. Hoffman sign on right. Involutary loss of urine with activity. Post LP headaches, nausea, not eating or drinking very much. Muscle twitching. Difficulty falling asleep. 9/28/09 Rheumatology consult received DOS 2/15/08 to 2/29/08. Assessment: Likely demyelinating process of unclear etiology. Post lumbar puncture headache. Emotional lability brought on by stress of current illness. Patient c/o “”legs falling asleep””, lower back pain, “”pins and needles”” right and left arms. Thinning hair. Atypical Raynaud’s symptoms, fingers appear dusky, livedo orver dorsum of hand. Eyes dry. Disconjugate movements extraocular muscles.”

Total   1          1.35%

Total   1          1.35%

355728-1         Not Serious     Primary           1          1.35%  1st vaccine: 11/28/08; Rash on hands appeared soon after, seen by Dr. on 12/7/09 for rash; 2nd vaccine: 2/7/09; 3rd vaccine: 5/1/09 followed by extreme tederness at site and muscle fatigue and pain all over body; numerous doctor visits, tests, and muscle bioposies led to diagnosis on 8/6/09 of dermatomyositis by Dr. During this period (11/28/08 – 5/1/09) rashes also appeared on elbows, knees, hips, and face. In looking back over the time period, there appears to be a connection between the vaccinations their impact on her immune system. Medical literature suggests a possible link between Gardasil and juvenile dermatomyositis, a disease that only affects 5 in 1 million people. 9/1/09 PCP medical records received DOS 2/3/09 to 8/19/09. Assessment: Nonspecific liver enzyme elevation. Nonspecific myalgias, joint complaints, possible rheumatological disorder. On 5/1/09 patient presented with complaints of a red, puritic rash. On the dorsum of and fingers of both hands, concentracted around MCP joints. Later complains of achiness and fatigue on arms and legs, sleeping more. Rash on elbows and knee. 1/7/2010 ED records received. Service date 6/29/09. Assessment: Lympahdenopathy, difficulty swallowing. Patient c/o that it is hard to swallow. Cervical lymphadenopathy. Body aches. Myalgia, sore throat, rash.

Total   1          1.35%

Total   1          1.35%

356757-1         Serious            Primary           1          1.35%  Information has been received from a health professional concerning a 28 year old female who on 28-AUG-2007 was vaccinated with the first dose of GARDASIL (lot# 658558/1061U) into her left buttocks. Not long after first dose, migraine headache started. On 25-OCT-2007, the patient was vaccinated with the second dose of GARDASIL (lot# 654539/0742U) into her left gluteus and on 25-FEB-2008, was vaccinated with the third dose of GARDASIL (lot# 655327/1287U) into her left gluteus. Concomitant therapy included ALESSE. On 01-MAY-2009, the patient passed out and was hospitalized, a spinal tap was performed. The patient had migraine headache started not long after the first injection. The patient was seeing a neurologist. A MRI performed showed abnormal results. The patient developed demyelination in brain. Questionable Lupus. Upon internal review, questionable lupus was determined to be an other important medical event. Additional information has been requested. 9/16/09 Received vaccine & GYN medical records. Records reveal patient experienced wt loss & fatigue. On 5/1 had seizure, hospitalized & neuro eval done. 10/6/09 Neurological consult received service dates 5/1/09 to 5/21/09. Assessment: Migraine Presented with c/o severe bifrontal headache and episode of syncope. Transient loss of consciousness. Episodes of weakness associated with headaches, visual disturbance, migraine headaches for past year associated with use of oral contraceptives.

Total   1          1.35%

Total   1          1.35%

356835-1         Serious            Primary           1          1.35%  “Evans Syndrome. Autoimmune hemolitic anemia + idiopathic thrombocytopenic purpura. Coombs positive (warm Ab). Hb=6 & plts. 20,000. Differential Dx and W/U. All negative and comrehensive. Incluging viral studies, lupus serologies and Bone marrow aspirate and biopsy. Cause still unknown. Treated with transfusions, IVIG, steroids and “”wait and see”” aproach. Ultimately given Rytuxan. Currently on ‘remission’ 9/28/09 Medical records and DC summary received from date of service 11/1/08 to 11/7/08. D/C DX:Evans Syndrome. Presented with: malaise x1month,fatigue, fever, sore throat, joint pain/swelling, cough, night sweats, anemia, thrombocytopenia. Insidious onset of symptomatic microcytic hypochromic hyperproliferative anemia with evidence of iron deficiency. TX: IV IG.”

Total   1          1.35%

Total   1          1.35%

357357-1         Not Serious     Primary           1          1.35%  The first two vaccines were no extreme signs,…just some minor ones like light headed, but after the 3rd vaccine the problems started within the following month. Reactions likes: shaking, anxiety, chest pain, trouble breathing, confusion, wart outbreak, blood issues (clotting and low oxygen levels) and later Dr’s believe she has lupus and Rhuematoid arthritis. She also just had a fibroma tumor removed from the same foot that had the large wart develop although different area. 10/26/09: Outpatient medical records received for dates of service 2/6/08 to 10/5/09. Dx: Mixed connective tissue disease, Major depressive disorder, Panic disorder with agoraphobia, Pap smear abnormal + HPV, Respiratory abnormality NEC, Anxiety state NOS, Raynaud’s syndrome. Assessment: Presents with persistent arthralgias of the hands and wrists, fatigue and achiness in neck without swelling. Had positive ANA, placed on Plaquenil. Also had positive lupus anticoagulant, but a subsequent test was negative. Started on Methotrexate weekly with positive results. Left forefoot soft tissue mass excision performed, pt. healing well at 4 weeks post op. Also had episode of hematemesis, and melena, endoscopy was normal. C/o body shakes, EEG-Abnormal. Also c/o dyspnea at times, 24 hour Holter monitoring was normal with no correlation between rhythm changes and reported dyspnea. Tendancy to desat. to 92% with exertion, though treadmill stress test was WNL; started on Advair and albuterol. Pt. has acne vulgaris and peringual warts. Additional meds.: Buspirone, Lexapro.

Total   1          1.35%

Total   1          1.35%

360064-1         Not Serious     Primary           1          1.35%  “Information has been received from a consumer concerning her 13 year old daughter with no pertinent medical history reported and no known drug allergies who in May 2007, was vaccinated with first dose of GARDASIL (dose, route and lot number not reported). There was no concomitant medication. Sometime after receiving the first dose, the patient started complaining of joint pain of knees and back, fatigue and tiredness. Then, the patient received her second dose of GARDASIL (dose, route and lot number not reported) and in November 2007, she received her third dose of GARDASIL (dose, route and lot number not reported). A few weeks after receiving the first dose, the patient developed a full brown uveitis. The patient was given steroids (name and manufacturer unspecified) which she had a reaction to and now, the patient was legally blind, but she had some outpatient eye surgeries and developed glaucoma. The patient was taken to a Hospital to see a physician and they did blood work and X-rays of her knees and back (results not provided) and the patient was diagnosed with autoimmune disease. The patient’s mother reported that the patient was put on infliximab (manufacturer unknown) and which did not help, and now was on HUMIRA which was helping her joint pain. The patient’s joint pain on knees and back, fatigue and tiredness, full blown uveitis, legally blind, outpatient eye surgeries, glaucoma and autoimmune disease persisted. Follow up information was received from a registered nurse. She stated that the patient received the GARDASIL vaccinations on the following dates: the first dose was given on 03-MAY-2007 (Lot number 656051/0244U, route not reported), the second dose was given on 10-JUL-2007 (Lot number 657621/0387U, route not reported) and third dose was given on 15-NOV-2007 (Lot number 658560/1062U, route not reported). There were no concomitant vaccinations administered at the time the GARDASIL vaccinations were administered. The Registered nurse stated that there was no documentation that the patient had any reaction to the GARDASIL vaccination between the 03-MAY-2007 to 15-NOV-2007. She stated that on 10-DEC-2007, the physician was notified that the patient had possible “”pink eye””. The patient was treated with eye drops (name of drops unspecified). On 11-DEC-2007, the patient complained of eye sensitivity. The patient’s eye drops were changed. The patient was tested for Lyme’s disease. On 18-DEC-2007, the patient was seen by an ophthalmologist. On 18-DEC-2007, the Lyme disease test was negative. On 27-DEC-2007, the patient’s eye drops were strengthened and “”prednisone drops”” added to the patient’s treatment. The patient complained of knee and joint pain on 27-DEC-2007. The patient was seen on 13-APR-2009, 27-APR-2009, 04-MAY-2009 and 07-MAY-2009. The patient was also referred to a rheumatologist. Upon internal review, legally blind was determined to be an other important medical event. Additional information has been requested. 10/16/09

Total   1          1.35%

Total   1          1.35%

363162-1         Not Serious     Primary           1          1.35%  Dermatomyositis – Dx’d 2/2008. 1st Dx’d by rash on knuckles found during DERM visit for acne on 2/7/08. Pt & mother stated rash had been present for few months. Rx’d with PLAQUENIL.

Total   1          1.35%

Total   1          1.35%

365958-1         Not Serious     Primary           1          1.35%  The winter following her Gardasil series the patient developed significant Raynaud’s Disease. Bloodwork included a + ANA and + RNP antibodies and low white count. So far she has not developed symptoms of SLE or mixed connective tissue disease, apart from general aching, but ANA has been elevated as high as 1:1280 speckled. THere is no family history of autoimmune disorders. Her Raynaud’s symptoms continue to be very significant and she is on daily Procardia XL 30 mg, year round. 11/13/09 Medical/lab/ vax records received. OV 10/20/08 DX: Reynaud’s syndrome. PE WNL.

Total   1          1.35%

Total   1          1.35%

371392-1         Serious            Primary           1          1.35%  60 second generalized tonic-clonic seizure followed by a second one 6 hours later; MRI negative; EEG markedly abnormal with frequent burst suppression activity; LP normal. No active infectious or neurological etiology found. Treating with antiepileptic and seeing slow recovery of mental status. 12/10 12/23 12/24 1/5/09: Hospital records received for dates of service 11/13/09 to 12/19/09: Dx: Encephalopathy, seizures, spinal lesion. Hospitalized after onset of tonic clonic seizures with bilateral upper and lower extremity shaking lasting 30 to 60 seconds with no respiratory compromise and urinary incontinence, unusual fatigue, fever, headache, sleeping more than normal. Hx. of enuresis worsened with admission, taking Dilantin and Trileptal. EEG abnormal but without epileptiform discharges. Also poor memory, poor appetite, ten pound weight loss over past month, nystagmus on lateral gaze both right and left, ataxic gait and slow, slurred speech. Intensive care unit admission after seizure with prolonged apnea. PICC Line placed. Treated with IVIG with marked improvement, though she did have a reaction to the IVIG with fevers, abdominal pain and a few days of low blood pressure. Discharged on antiepileptics.

Total   1          1.35%

Total   1          1.35%

374854-1         Serious            Primary           1          1.35%  I received one (1) shot of the HPV vaccine Gardasil on 09/25/09. Two months later, on 11/19/09, I went into my doctor with petechiae (red blood dots) on my legs, excessive bruising on my legs and arms, and mouth lumps (inside lower lip). I took a blood lab and when the results came in, I was at 8,000 platelet count and told to go to the ER right away. Treatment (steroids alone) lasted for 2 days, and had to go back to the ER, this time with arm numbness/temporary paralysis added to the issue. Treatment with a stronger medication (Anti-D) was administered, but again, two days later, I was back in the ER. A third treatment was administered (IVIG), and it lasted two weeks. Now I am scheduled to go back to the hospital for admission to do another dose of this. Aside from pain at the injection site for over a month, I have also now been diagnosed with the autoimmune disease thrombocytopenia (low blood platelets) which I have been dealing with for over a month at an aggressive level, and it shows no signs of getting better. During this condition, I have had arm numbness/temporary muscle paralysis, as well. 12/23/09 PCP medical records received. Service dates 11/19/09 to 12/21/09. Includes ED visit 11/21/09. Assessment: Idiopathic Thrombocytic Purpura. Patient c/o feeling warm, fatigue. Cough, congestion. Oral contraceptive use. Hematochezia. Paresthesia. Bruising on forearms. Presents at ED with petechiae. Multiple bruises thighs and feet. Bright red blood from nose. Tired. Diarrhea. Bumps in lower lip. Thrombocytopenia. 12/28/09 Discharge summary, hospital records received. Inpatient Service dates 12/8/09 to 12/11/09. Includes Labs from 11/23/09 to 12/22/09. Assessment: Thombocytopenia, Idiopathic Thrombocytopenic Purpura. Prior hospital admissions 11/19/09 to 11/23/09 for Thrombocytopenia / Idiopathic Thrombocytopenic Purpura. 12/2/09 to 12/3/09 for Thrombocytopenia, weakness, heaviness. Patient presented after follow up labs showed a platelet count of 20. (R) arm subjective weakness, headache, nose

Total   1          1.35%

Total   1          1.35%

374963-1         Serious            Primary           1          1.35%  Pain in shoulders mostly and other joints, knees, feet, elbows, jaw.

Total   1          1.35%

Total   1          1.35%

379292-1         Serious            Primary           1          1.35%  Within 1 month after receiving vaccination progressive clumsiness noted with complaints of leg pain with inability to run without falling. Eventually, lost ability to run and only able to participate in some aspects of gym classes. Alternate written assignments had to be done. On April 9,2008 had severe pain to left leg while in bed. While stepping up onto school bus, passed out. Complained of dizziness at that time. pain progressed to right leg that day with tingling and numbness. Taken to ED, CT scan of head and labs done. Referred to neurologist. Many blood tests performed, EMG, nerve conduction studies, MRI’s. May 1, 2008 reported right leg pain worsening and now present in right hip and waist. Referred to neurologist due to progressive weakness and right leg lag. Adaptations have had to be made at school through the 504B plan to accomodate for her disabilities. Stairs are very challenging. Swallowing difficulties started within last 3 months. Now seeing neurologist, rheumatologist, endocrinologist to find cause of proximal weakness. Lots of autoimmune studies have been done and repeated. No answer to this problem for a child who was in perfect health prior to this vaccination. Bills are immensely expensive and continue.

Total   1          1.35%

Total   1          1.35%

382049-1         Not Serious     Primary           1          1.35%  Nausea HA neck pain wt loss chronic fatigue hair loss memory loss chest pain. Auto immune dg Hpylori x 2 Dizzy since 1st vaccine 3/09.

Total   1          1.35%

Total   1          1.35%

384714-1         Not Serious     Primary           1          1.35%  Initial and follow-up information has been received from a 21 year old female office worker concerning herself who in March 2009, was vaccinated with the first 0.5 mL dose of GARDASIL (LOT# not reported). On 01-APR-2009 the patient woke up and had loss of vision in her right eye. At this time of reporting, the patient’s loss of vision had not recovered. Upon internal review, loss of vision was determined to be an other important medical event. Additional information has been requested.

Total   1          1.35%

Total   1          1.35%

387752-1         Serious            Primary           1          1.35%  Small stroke in left optic nerve – optic neuritis.

Total   1          1.35%

Total   1          1.35%

399318-1         Not Serious     Primary           1          1.35%  Information has been received from a physician concerning a 14 year old female patient who 10 days ago, on 13-OCT-2009 was vaccinated with the third dose of GARDASIL (lot number not reported). Concomitant vaccine therapy on the same day included a dose of FLUZONE. On 22-OCT-2009 the patient developed an urticarial/vasculitis like rash only on her palms and soles of her feet, she also developed a headache and fever. Medical attention was sought, the patient visited the physician’s office. It was unspecified if there were lab studies performed. The patient took ibuprofen for the fever and headache and BENADRYL for the rash with no response. At the time of the report, the patient had not recovered. Follow-up information has been received from the physician’s medical records concerning the 14 year old female patient had no illness at the time of vaccination who on 13-OCT-2009 at 15:00 pm was vaccinated IM in the left arm with the third dose of GARDASIL (lot number 660393/0067X). The patient developed cervicalgia/vasculitis rash itchy and throbbing on her palms and soles. The patient had headache too. On 23-OCT-2009 the following labs were collected: ASO screen positive, titer 200 IU/ml (reference negative <200 IU/ml). The patient was treated with 500 mg amoxicillin twice a day for 10 days, Rheumatoid factor negative, ESR-Westergren results of 2 MM/HR (reference 0-20) interpreted as no serologic evidence of infection with B. burgdorferi (Lyme), complement CH50 52 U/mL (reference 30-75), antinuclear AB positive, For CBC, neutrophil count 79% (reference 35-65%) and lymphocyte count 15% (reference 25-45%), lymph absolute 1.09 K/uL (reference 1.3-2.9 K/uL), remaining CBC were within normal limits, total bilirubin 1.4 MG/DL (reference 0.2-1.2), IgM 288 MG/DL (reference 48-226); on 28-OCT-2009 the following lab results were negative: DNA DBL STR AB, SS-A/RO ABS, SS-B/LA ABS, SM antibodies, U1RNP antibody, SCL 70 ABS, JOI antibodies. On an unspecified date, the patient recovered. The physician considered the events non serious. Additional information is not expected.

Total   1          1.35%

Total   1          1.35%

400175-1         Not Serious     Primary           1          1.35%  “Information has been received from a nurse concerning her daughter, a 19 year old female patient with no past medical history or allergies who on 06-SEP-2006 was vaccinated with the first dose of GARDASIL (lot number, route and site not reported). The patient was not taking any medications prior to GARDASIL. The patient received the remaining two doses “”at the appropriate scheduled times.”” About one month after receiving the first dose of GARDASIL, the patient developed pain in her ankle and had difficulty ambulating up and down stairs. She was seen by the family physician who diagnosed her with tendonitis. One month and a half after the first dose, the patient was seen by an orthopedic surgeon and underwent blood tests and a MRI. The nurse stated that the ““blood work was erratic for a healthy teenager”and the ANA results were positive. The patient was then referred to rheumatologist, which she was still seeing. The patient was diagnosed with an autoimmune disease and reactive arthritis in her hip, knee and ankle. She was placed on therapies with PLAQUENIL, Vitamins, Fish oil, tramadol, and ibuprofen. The nurse reported that the patient was also seen by a urologist since “”she was spilling protein in her urine due to the ibuprofen””. The ibuprofen was discontinued. The patient saw an eye specialist every three months to evaluate for possible visual side effects that may occur with the PLAQUENIL and tramadol (no visual side effects reported at this time). The nurse reported that the patient did not require any hospitalization or life saving measures due to this reaction. This reaction was not related to a cancer or an overdose. The nurse stated “”This is something that she is going to have for the rest of her life.”” At the time of the report, the patient did not recover. The health care professional contacted during telephone follow-up could not supply the following information: date of birth, dates of vaccination/therapy, dose number (if applicable), lot number (if applicable), date of event, recovery status, hospital name (if applicable), healthcare provider contact information. Follow up information has been received from a receptionist of a doctor’s office who reported that the patient is an 18 year old female (previously reported as 19 year old). Additional information has been requested.”

Total   1          1.35%

Total   1          1.35%

406578-1         Serious            Primary           1          1.35%  Memory and cognitive deficit May to present – Hair loss, nose bleeds, fatigue, lethargy, dry eyes, positive ANA test for an autoimmune Dx for either lupus, MS, arthritis and Sjorgrens Neuro Children’s hospital. Continues treatment.

Total   1          1.35%

Total   1          1.35%

407512-1         Not Serious     Primary           1          1.35%  Beginning 01/04/2009 I have experienced the following symptoms: -chest pain -shortness of breath -nausea -pain radiating down legs and arms -joint pain -frequent heart burn -frequent burning when urinating/ UTI -tired all the time -painful superficial lump/ clot -poor circulation in legs -no period for over 9 months (not pregnant)

Total   1          1.35%

Total   1          1.35%

414486-1         Serious            Primary           1          1.35%  Patient’s body temperature went up to 104 and she couldn’t walk. She was is a lot of pain and was admitted to the hospital.

Total   1          1.35%

Total   1          1.35%

414754-1         Serious            Primary           1          1.35%  SECOND INJECTION OF GARDASIL- FATIGUE, POLYDIPSIA, COLD EXTREMITIES, CHEST DISCOMFORT, TINNITUS, HEADACHES, MUSCLE PAIN AND WEAKNESS, SEVERE ABDOMINAL PAIN, BLOATING, SLEEP TROUBLE, IMPAIRED CONCENTRATION, CHILLS, HAIR FALLING OUT IN CLUMPS. THIRD INJECTION- SAME SYMPTOMS AS ABOVE WITH INCREASE IN INTENSITY AND DISCOMFORT.

Total   1          1.35%

Total   1          1.35%

423875-1         Serious            Primary           1          1.35%  SLE diagnosed 10/2010 months ago admitted with progressive weakness, numbness, and tingling in her lower extremities for last 2 weeks prior to admission. 1. Acute infective demyelinating polyneuropathy, likely Guillain-Barre syndrome. Patient gave a history of progressive weakness, numbness, and tingling following a bout of gastroenteritis. She stated that her symptoms had gotten progressively worse for 2 weeks and was having difficulty with walking. Extensive workup including MRI, CT scan, as well as lumbar puncture. A lumbar puncture did not show any evidence of infection. MRI showed no evidence of infarction. CT brain was negative. MRI of the spine showed abnormal thickening and enhancement of the ventral and dorsal cauda equina nerve roots, likely compatible with Guillain-Barre syndrome. Patient was started on 5 doses IVIG therapy with the last dose on 4/22/2011. EMG and nerve conduction studies on 4/15, and the EP findings were consistent with acute severe infective demyelinating polyneuropathy consistent with possible Guillain-Barre syndrome. Patient never had any plasmapheresis done. Started on Solu-Medrol, which was later changed to prednisone. Her FVC was maintained at greater than 2 L always, and it was checked every shift. Patient still continues to have some lower extremity weakness. To TIRR for therapies 2. Acute renal failure, likely secondary to lupus nephritis. During the hospital course, she was noted to have acute renal failure around 4/17/2011. Her kidney function worsened, and she underwent a renal biopsy on 4/20/2011, which showed class 5 membranous acute glomerulonephritis consistent with lupus nephritis, as well as marked acute tubular injury. Patient was started on dialysis, and she later had a Perm-A-Cath placed and continues to be on hemodialysis. 3. Acute blood loss anemia, likely secondary to retroperitoneal hematoma from Bipsy site plus bleeding from femoral catheter site after removal plus anemia of chronic disease, given iron study showing elevated ferritin. Following the kidney biopsy, patient was noted to have a significant drop in hemoglobin. She was noted to have developed right renal hematoma, for which she was managed symptomatically. Also, she had iron studies, which showed elevated ferritin consistent with anemia of chronic disease, and renal is on board for the same. 4. SLE. Patient was diagnosed with SLE about 6 months ago, and her anti-ANA, anti-Smith/anti-RNP, as well as anti-double stranded DNA along with anti-SSA/anti-SSB antibody positive. Rheumatology has been on board throughout the hospitalization, and her hydroxychloroquine was continued. Solu-Medrol was later changed to prednisone as per rheumatology recommendations, and patient will continue prednisone 60 mg daily, and rheumatology will see her at TIRR and adjust dose accordingly. Patient has not been restarted on CellCept, which was held given her worsening renal function. Rheumatology will follow up at TIRR regardin

Total   1          1.35%

Total   1          1.35%

425376-1         Not Serious     Primary           1          1.35%  Severe head, neck, back pain. Cognitive decline. Brain fog. Fever, blacking out (syncope). Pressure in head and neck, dizziness. Nausea. Chronic fatigue/several weeks duration/have seen Neurologist, ENT, Rheumatologist/many labs, MRI, CAT scan, LP – no definitive diagnosis to date.

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