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Fatigue from HPV (GARDASIL) 2009

Vaccine Manufacturer:MERCK & CO. INC.
Vaccine Code:HPV4
Vaccine Type:HUMAN PAPILLOVAVIRUS QUADRIVALENT
Vaccine Name:HPV (GARDASIL)
Year Reported:2009
Symptom Reported:Fatigue

HPV (GARDASIL) Side Effects Report #336473
HPV (GARDASIL) vaccine side effect was reported on 12/23/2008. Female patient, 18.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Fatigue, "Onset increased muscle pain, fatigue, weakness, dysphagia, weight loss. Pt requiring Prednisone IVIG every q monthly. Methotrexate headache, muscle atrophy. 2/6/09 Received PCP medical records of 11/11/08-1/20/09. FINAL DX: polymyositis, likely MCV4 vaccine related; osteomalacia; neuropathy; pernicious anemia; tachycardia; ataxia; Budd-Chiari syndrome; dermatomyositis. Records reveal patient experienced muscle weakness, paresthesias, leg pain. Referred to Neuro & Rheum. Tx w/PT & meds including methotrexate, imuran, steroids, enbrel, bicillin, IVGG. Had to drop out of college due to illness. 04/6/2010 Patient's condition never improved and she died on 3/23/2009." NoneIron-deficiency anemiamuscle biopsy; MRI separate. Dx clinical myositis . Patient died on 3//09/03/2.

HPV (GARDASIL) Side Effects Report #336474
HPV (GARDASIL) vaccine side effect was reported on 12/18/2008. Female patient, 13.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Fatigue, "After my daughter received her 1st shot of 3 (to complete full dose) she started having problems soon after.- light headed, dizziness, fainting, fatigue, loss of appetite, change in menstrual cycle, blurred vision, headaches, joint hip pain, irritability, depression, throwing up and bad cramps. FYI- we opted out of the last two shots. Took patient to regular Dr. appt. We were than told that she should get the HPV shot I was reluctant because I don't have or never had cervical cancer and neither had my mother. They said she would need 3 series of shots all together. After the 1st shot (3/12/08) we started to notice all the symptoms that are describe on page 1. She was a tract runner for her school and very good at that. But after the shot anytime she would run she would throw up and cramp right after. Once she was able to make it half way when she was running 100 yard dash. 1/22/09 Received PCP clinic medical records of 3/12/08 FINAL DX: none provided Records reveal patient experienced rash on abdomen waxing & waning since 12/07. Only dry skin found on exam & tx w/lotion. No other records available. 02/01/2010 Still has side/hip pain whenever she over erats herself insports." Seasonal allergies; Patient was very healthy before this shot and the only conditions that she had or has is seasonal allergies. . Patient recovered.

HPV (GARDASIL) Side Effects Report #336945
HPV (GARDASIL) vaccine side effect was reported on 01/09/2009. Female patient, 18.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Fatigue, "Woke up that Sunday a.m. feeling very tired. Complained of arms feeling heavy and a headache. Later that day complained of numbness and tingling which progressed bilaterally up both her arms throughout that day and into the next several days. Complained of being cold. She slept up to 16 hours/day. Contacted the physician on-call on Monday (Labor Day) who suggested that we wait a week to see what course the symptoms took. Symptoms continued and progressed to complaints of difficulty walking due to heaviness of legs. Numbness and tingling progressed above elbows, but no further. No difficulty breathing. On Wednesday we went to see her primary care physician who felt she had mono, and that it was not related to the HPV vaccine. (patient had NO sore throat) Her doctor ran blood tests, but these returned negative for mono. Patient began to get less tired and less weak beginning on Friday, September 5th, during the day, but then returned to the weakened state on Saturday through Tuesday. And then rapidly recovered to her usual self by Saturday, September 13th. She has had no recurrence of the symptoms since. (NOTE: Her maternal grandfather was diagnosed with Myasthenia Gravis at age 70, and a cousin on her mother's side has Juvenile Rheumatoid Arthritis that first surfaced after a tetanus vaccine when she was 10 years old)." . During the same period patient was treated with Nuvaring. Patient recovered.

HPV (GARDASIL) Side Effects Report #336947
HPV (GARDASIL) vaccine side effect was reported on 01/10/2009. Female patient, 31.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Fatigue, "Low grade fever, sore throat, swollen neck lymph nodes, runny nose, muscle aches and fatigue. Taking ibuprofen." NoneNone . During the same period patient was treated with "Seasonale, zoloft 50mg". Patient recovered.

HPV (GARDASIL) Side Effects Report #337465
HPV (GARDASIL) vaccine side effect was reported on 01/15/2009. Female patient, 17.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Fatigue, "Within 3 days of receiving the 2nd round of the HPV vaccination, my daughter began with severe pain in her arms, legs, and hips, difficulty walking which progressed to needing assistance, excruciating pain, numbness/tingling in her lower extremities/feet with weakness in her legs, inability to hold up her body weight, legs would buckle and she would fall when trying to stand, constant muscle cramps and charly horses just with normal movement, her skin was painful to touch, severe aching even with rest, fatigued, pale, lethargic, generalized weakness. 1/21/09 MR received for DOS 1/1-2/2009 with D/C DX: Fibromyalgia. L lens cataract s/p surgical correction. Idiopathic anaphylaxis. H/o syncopal spells. GERD. Migraine H/As. S/P T&A. H/o prematurity. Pt presented to ER with c/o generalized muscle pain, paresthesias and weakness since vax on 12/17/08. Pt has been ~bed bound~ except for trips to BR with assistance. Also reports generalized weakness, fatigue and anorexia. Currently tapering off steroids prescribed by PCP. PE (+) for antalgic gait and lower extremity pain. 2/20/09 MR received. Pt initially presented 12/26/08 with c/o pain all over since 2nd HPV shot. Had some aches after 1st but pain flared after most recent. Seen by GI for abdominal pain and given dx of inflammation if GI. Assessment: Adverse reaction to Gardasil flaring ANS." None."Idiopathic Anaphylaxis, Fibromyalgia, GERD. PMH: NKA. prematurity. Congenital cataract. Fibromyalgia-dx 2/2008.""blood work, nerve conduction study. Labs and Diagnostics: CBC with WBC 13,940, RBC 5.28, Hgb 15.4. Hct 46.1. UA (+) for 52 WBCs. EMG/NCS WNL. ALT 54. AST 27. Alk Phos 80 (low). LDH 266. Ferritin low at 9." . During the same period patient was treated with "Lyrica, Amytriptyline, Entocort, Birth control pill, Ultram". Patient was hospitalized Patient recovered.

HPV (GARDASIL) Side Effects Report #337467
HPV (GARDASIL) vaccine side effect was reported on 01/15/2009. Female patient, child 12.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Fatigue, "High fevers 102+, Nausea, Dizzy, lethargic, weak & tired" none . During the same period patient was treated with none. Patient recovered.

HPV (GARDASIL) Side Effects Report #337545
HPV (GARDASIL) vaccine side effect was reported on 01/08/2009. Female patient, 15.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Fatigue, "10/07- Vomiting, Diarrhea Daily-No reason hospitalized for dehydration lost 30lbs. Continued to be sick- Colonoscopy, MRI problems with Blood sugar 12/08- Fluid on knees, All over rash, dizzy and disoriented, UTI's 1/21/09 Received ER medical records of 4/08 through 1/9/2009. 4/30/08 Seen for rectal bleeding probably due to hemorrhoids or anal fissure. Referred for colonoscopy. 6/25/08 ER visit for HA s/p struck on head accidentally by hand weight. CT scan WNL. Stable & d/c to home. 9/15/08 ER for fever/chills, cough, diarrhea rash, stuffy nose, ear pain, sore throat. Had recently been diagnosed w/diabetes & was on oral meds & BCP. 1/9/09 ER for tired, dizzy,numbness, shaking in knees & hands, burry vision, slurred speech. Had cough, fever, chills, intermittent abd pain, chronic diarrhea. Dx w/mononucleosis. 1/23/09 Received ER medical records of 12/18/2008. FINAL DX: records reveal patient see for diarrhea x 2 weeks, mild dehydration. Tx w/IVF & d/c to home. 2/2/09 Received ID & Immunology & Endocrine Clinic notes . Endocrine 9/30/2008 FINAL DX: hyperinsulinemia, oligomenorrhea likely POS, snoring, URI, abnormal weight gain Patient was on metformin at this time & checking blood sugars daily. ID & Immunology 1/20/2009 FINAL DX: severe chronic progressive fatigue syndrome w/chronic diarrhea & abd pain & vomiting, chronic HA, orthostatic dizziness, peripheral neuropathy symptoms, large joint arthralgia, patchy alopecia, weakness, folate deficiency, ?hyperinsulinemia, slight buffalo hump w/elevated ACTH, glucose metabolism abnormality Records indicate patient had fatigue x 2 mo, constant HA & diarrhea, frequent abdominal discomfort, arthralgias large joint w/occasional swelling. S/S present since 11/2007 following acute illness of vomiting & diarrhea requiring IVF. Illness lasted approx 1 mo & pt lost 25#. Since then had decreased energy & frequent URIs, academic decline, unable to participate in sports. Patches of hair loss, numbness & tingling LEs, intermittent itchy rash. Re" None"None PMH: UTIs, HA, dehydration, contraception irregular periodsrecently changed from depoprovera to yasmin""LABS: Blood work 1/20/09: ESR 32(H). CRP <0.5. CBC & chemistry WNL. ANA neg. IgA 73, IgG 1532, igM 105. CT 4/2008 c/w tonsillar abscess. MRI head 7/2008 WNL. Rocky Mountain spotted fever test (+). Abdominal x-ray revealed constipati" . During the same period patient was treated with YASMINE. Patient recovered.

HPV (GARDASIL) Side Effects Report #337624
HPV (GARDASIL) vaccine side effect was reported on 01/18/2009. Female patient, 15.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Fatigue, "Seizure activity, lower paralysis, exhaustion, nausea and vomiting, brain fog, difficulty concetrating, low blood pressure, Painful periods and off cycle, chest pain, joint pain, muscle pain and weakness, blurred vision, tremors, weight loss, personality change, dizziness, difficuly breathing, oxygen deprived, hair loss, Skin pale. 2/25/09 Received PCP medical records of 10/25/07-12/24/2008. FINAL DX: none provided Records reveal patient experienced good health on 10/25/07. RTC 11/15 w/sore throat, left ear pain & nausea x 1 wk. Dx w/viral URI. RTC 11/23/07 w/left knee pain/swelling x 5 yrs. Dx w/patellofemoral syndrome, tx w/meds & referred to PT. RTC 1/8/08 w/neck & throat discomfort. Dx w/voice weakness, probable strained cricopharyngial nerve. Tx w/meds & referred to ENT who dx w/dysphonia following likely vocal misuse. RTC 2/8/08 w/fatigue, upset stomach, weight loss, polydipsia & nausea x 1 wk. RTC 2/12/08 s/p fainting in school, lightheaded x 1 wk. Dx w/syncopal episode & possible dehydration, weight loss & fatigue. Tx w/IVF & meds. DM w/u neg. RTC 2/28 s/p ER visit for generalized pain. Had been hospitalized previous wk, dx w/pseudoseizure & followed by neuro. 3/27/09 Received Neuro consult medical records of 2/25-3/7/2008. FINAL DX: none provided. Consult states excessive tiredness, nausea & weight loss likely secondary to viral illness; intermittent weakness of legs posssibly due to dehydration vs presyncope; & recent onset of nonepileptic shaking events. Records reveal patient experienced fatigue during vacation out of state approx 3 wks prior to eval. Saw PCP after vacation for nausea, weakness. Hospitalized x 3 days. Eval by peds neuro at that time & dx w/syncope vs near syncope. Improved & d/c to home. Was able to return to school f/t & traveled out of state. Collapsed & had to be brought back home w/trembling of extremities. Admitted to hospital for further neuro eval. Exam & testing all WNL. D/C to home. Seen in ER x 2 for recurrence of shaking & aggressive behav" none"Allergy penicillin PMH: Asthma, strep throat.""PCOS LABS: video EEG, MRI brain & spine WNL. CPK WNL. Alk phos 51(L). PAP smear WNL." . Patient was hospitalized Patient recovered.

HPV (GARDASIL) Side Effects Report #337761
HPV (GARDASIL) vaccine side effect was reported on 01/16/2009. Female patient, 14.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Fatigue, "Week of 1/23/2007 pain at site of GARDASIL injection #2 5 week past GARDASIL. Myalgias, hip pain, elbow, wrist, hand, finger, knee, foot pain, fatigue, petechiae legs, decreased ROM, lab NL. Seen by rheumatology, resolved completely 4/3/08. Followed by rheumatology no reoccurrence as of 1/09. 1/29/09 Received PCP medical records which included Rheum & Ortho consults. FINAL DX: Polyarticular reactive arthritis Records reveal patient experienced usual state of good health on 5/18/07, day of HPV#1 & Varicella vaccinations. RTC 8/23/07 with symptoms x 3 days of pain & swelling of multiple joints; gen aching; fatigue; decreased appetite; difficulty standing, walking & making fist or extending fingers; low grade fever; oral ulcers; scattered petechiae of LEs; searing pain where HPV#2 given 7/18/07. 6/20-23 had illness w/cough, sore throat, fatigue, HA, fever, pain in hips/ankles, stiff joints. Rheum consult of 9/5/07, 4/3/08, 7/10/08 & 1/5/09. Ortho consult of 7/30/08. Referred to pulm & ID on 1/5/09." None"Laryngitis cough, 4/07 PMH: Mononucleosis. family hx: arthritis.""ANA, ASO, CRP, 3.5; RFU, negative; VaU, negative; CGB dip, negative; CMR, negative; ESR, negative LABS: CBC, chemistry, ESR, ANA, RF, & UA all WNL. CRP 3.5(H). Hip/pelvis x-ray & CT scan abnormal & revealed pars defects, spina bifida o" . Patient recovered.

HPV (GARDASIL) Side Effects Report #338592
HPV (GARDASIL) vaccine side effect was reported on 01/16/2009. Female patient, 16.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Fatigue, "Information has been received from a 16 year old female patient with no drug reactions/allergies, who on 09-DEC-2008 was vaccinated with the first dose of GARDASIL. There was no concomitant medication. On 15-DEC-2008 the patient experienced joint pain, swelling fatigue and pain in her legs. The patient spoke to the physician, At the time of reporting, the patient had not recovered. Additional information has been requested.2/5/09-records received-12/9/08 received 1st Gardasil injection in left deltoid. No C/O illness or fever. Parent on 12/23/08 stated child might have mono.2/4/09 called MD office C/O possible reaction to vaccine, seen by pediatrician with C/O joint pain, fatigue, pain and swelling of legs." NoneNone . During the same period patient was treated with None. Patient recovered.

HPV (GARDASIL) Side Effects Report #338646
HPV (GARDASIL) vaccine side effect was reported on 01/16/2009. Female patient, child 12.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Fatigue, "Information has been received from an office manager at the physician's office, concerning a female patient, who was vaccinated with first, second and third doses of GARDASIL (dose, route, lot # not reported). The office manager reported that the patient completed her GARDASIL vaccination series a couple of months ago and started experiencing hip pain and headaches. At the time of the report, the patient had not recovered. Follow up information was received from the Registered Nurse on 23-DEC-2008 which reported: The patient was vaccinated with three doses of GARDASIL on 19-SEP-2007, 29-NOV-2007 and 03-APR-2008 respectively. The patient experienced hip pain, headaches, and stomach pain and that were all still ongoing. The patient also experienced fatigue but that has resolved. Follow up information has been received from a Registered Nurse on 30-DEC-2008 which reported that the lot number that was administered was: 660387/19670. The patient was administered the vaccine at her pediatrician's office. The patient was also administered varicella virus vaccine live (Oka/Merck) (MSD) and hepatitis B virus vaccine rHBsAg (yeast) (MSD) on the same day the patient received her third dose of GARDASIL. Additional information has been requested. 2/4/09-records received-presented on 11/17/08 with C/O run down, tired. 11/24/08 still very fatigued, dizzzy, occasional. 12/16/08 C/O headache. Possibility treated by another physician prior to presenting on 11/17/08. 2/23/09-records received-office visit 1/20/09-C/O headache, neck in pain for past 3 months. Holter monitor supraventricular ectopic beats noted. 12/30/08 increasing headaces." UnknownUnknown 2/4/09-records received- HA. Holter monitor normal EEG normal with mild swelling of background. Chemistry normal. Chest x-ray no evidence of infiltrate or pleural effusion. . During the same period patient was treated with Unknown. Patient recovered.

HPV (GARDASIL) Side Effects Report #338688
HPV (GARDASIL) vaccine side effect was reported on 01/16/2009. Female patient, 18.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Fatigue, "Information has been received from a physician for GARDASIL vaccine, concerning an 18 year old female patient with no previous medical history reported who on 09-SPR-2008 was vaccinated with the first dose of GARDASIL. On 15-JUN-2008 the patient was vaccinated with the second dose of GARDASIL and on 05-NOV-2008 with the third dose of GARDASIL. On 04-DEC-2008, a home pregnancy test was performed and the result was positive. The patient reported to the physician that she was tired. The patient sought medical attention, by phone call. Additional information has been requested." "Pregnancy, NOS (LMP= unknown)""Beta-human chorionic, 12/04/08, positive, home pregnancy" . During the same period patient was treated with Unknown. Patient recovered.

HPV (GARDASIL) Side Effects Report #337792
HPV (GARDASIL) vaccine side effect was reported on 01/21/2009. Female patient, 25.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Fatigue, "extreme weakness, fatigue, dizziness, severe mood changes, anxiety, low grade fever, severe headaches, chills 1/30/09 Received PCP medical records of 1/22-1/30/2009. FINAL DX: Records reveal patient experienced weakness, dizziness, moody, decreased energy after HPV #1 & #2 given 7/10/2008 & 9/11/08. Increased fatigue, moody, nervous, heaviness in legs, sensitive to touch, generalized aching, low grade fever, chills after HPV#3 1/20/09. RTC 1/30 symptoms except dizziness persist & now w/tingling in back & arms. Difficulty sleeping. DTRs WNL. Dx w/rhinitis & possible early sinusitis. Tx w/nasal spray & given Rx for antibiotics if symptoms persist." none"allergy to Bactrum and Ceclor PMH: bronchitis, pneumonia. Hives. Family hx: arthtis, DM, HTN."LABS: WBC 13.1(H). ESR 4(N). . During the same period patient was treated with none. Patient recovered.

HPV (GARDASIL) Side Effects Report #337797
HPV (GARDASIL) vaccine side effect was reported on 01/21/2009. Female patient, 18.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Fatigue, "Headaches, periods were very erratic. She would have them every 14 days @times, and others just spotting. Very bad cramps and periods were heavier after the 1st Gardasil shot. Wasn't her normal spunky and happy self. She was very tired and the last few weeks before she passed away, sheslept alot during the day which she never did. Never had any other problems prior to the Gardasil shots. She recieved all three shots in the series. Last shot was 5-2-2007. 2/9/09-autopsy report received-COD-undetermined by autospy and toxicology.3/18/09-records received-well visit C/O contact dermatitis, nasal congestion, itchy sore throat times 2-3days. HPV4 lot#1424 F received 1/3/07 in right deltoid. Lot #0384U received 5/2/07 left deltoid and 12/2/08 lot#0955F left deltoid." "Went in for sinisitus, and had a sore throat. She had bad sinus allergies. But they still gave her the shots."Seasonal allergies. None other.4/7/09-path report received-multiple tissues with extensive autolysis and bacterial overgrowth. Molecular evidence of a Clostridium sp. . During the same period patient was treated with "Nasonex (Pseudovent 400 substituted for Entex 400 120 capsule),Claritan, Triamcinolene Acetonide cream for rash on wrist.". Patient died on 1//07/08/3.

HPV (GARDASIL) Side Effects Report #337817
HPV (GARDASIL) vaccine side effect was reported on 01/20/2009. Female patient, child 11.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Fatigue, "Information has been received from a physician concerning a 11 year old female with no pertinent medical history who on 12-SEP-2008 was vaccinated intramuscularly with a first 0.5 ml dose of GARDASIL (lot #660618/0572X). There was no concomitant medication. ~Three months after administration of her first dose of GARDASIL~, on 12-DEC-2008 the patient experienced weakness, sore throat, nausea, vomiting, diarrhea, paleness and abdominal pain. ~One month later~, the patient's symptoms had not resolved and she was also experiencing chest pain, headaches, dizziness, swollen lymph nodes, chills and myalgia. The patient had office visits. ~White blood cell differential count and white blood cell count~ were normal. ~Four weeks ago~, on approximately 12-DEC-2008, the patient was prescribed PRILOSEC. At the time of the report, 09-JAN-2009, the patient had not recovered. Follow-up information received on 12-JAN-2009 from the physician via medical records indicated that on 18-DEC-2008 the patient was taken to the physician's office for follow-up. It was reported that the patient had a sore throat and abdominal pain which persisted one month. The patient vomited for four times on 08-DEC-2008 (previously reported as 12-DEC-2008) and had a diarrhea ~last week~. There was no blood. The patient was treated with omeprazole, 2-3 times daily for 3 weeks. At the time of the follow-up visit, the patient's abdominal pain worsened and she also had chest pain with deep breath, cough, headaches which happened ~every day for one week~ and cough. Lab tests performed on 18-DEC-2008 included: giardia antigen was negative, stool culture revealed no salmonella, shigella or campylobacter SP. isolated, white blood cell count and white blood cell differential count were normal, Epstein-Barr viral capsid antigen immunoglobulin M antibody was negative, EBV capsid antigen immunoglobulin G antibody and nuclear antigen immunoglobulin G antibody were positive. It was reported that the patient's mother was suspecting that her daughter's ~r" None. PMH: none"Stool Giardia lamblia, 12/23/08, negative; WBC count, 12/18/08, 7.3 thou; Red blood cell count, 12/18/08, 4.73 mill; Hemoglobin, 12/18/08, 14.0 g/dL; Hematocrit, 12/18/08, 39.9%; Mean corpuscular volume, 12/18/08, 84 fL; Mean corpuscular, 1" . During the same period patient was treated with None. Patient recovered.

HPV (GARDASIL) Side Effects Report #338284
HPV (GARDASIL) vaccine side effect was reported on 08/19/2008. Female patient, child 12.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Fatigue, "Headache, chills, fatigue, fever (highest 103.2 F). These symptoms lasted 4-5 days. Still had headache 8/18/08." NoneAllergic to PenicillinNone . Patient recovered.

HPV (GARDASIL) Side Effects Report #338424
HPV (GARDASIL) vaccine side effect was reported on 01/27/2009. Female patient, 24.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Fatigue, "I had my first injection on 7/10/2008. Since my second injection (9/26/2008), I haven't had a regular menstrual cycle, even while on birth control. I am very tired and weak all the time. I was also diagnosed with autoimmune thyroiditis (10/20/2008). Prior to the injection, I had hypothyroidism. I have had urinary tract infections/kidney infections. I have had pain in my left hip area/leg and back. The pain shoots down my left leg, also injection leg. The pain is so annoying and constant it keeps me up at night. 2/2/09 Received OB/GYN medical records 7/10/08-1/28/2009. FINAL DX: dysuria, irregular menses Records reveal patient experienced good health on 7/10/08 & requested to resume BCP(yasmin) after being off x 6 mo. RTC 11/20/08 w/irregular menses. Had self d/c'd BCP & thyroid med had been adjusted recently as well. Contraception changed to nuvaring. RTC 1/28/09 w/leg pain since 7/08, continued irregular menses & UTI s/s. Had self d/c nuvaring & bcp. Recently dx w/Hashimoto's thyroiditis 05/07/09 Received Internal Medicine records 12/10/07-01/14/09 FINAL DX: Hypothyroidism Well patient visits. Adjustment of levothyroxine dosage" n/a"Hypothyroidism Family hx: DM. HPV #2 Lot # 0570X, given 9/26/08""Bloodwork in October and December 2008 and January 2009 by Dr. Records received 05/07/09 - LABS: Thyroglobulin Antibodies = 188 IU/mL, Thyroid Peroxidase = 134 IU/mL" . During the same period patient was treated with "Armour Thyroid, Yasmin, Nuvaring". Patient recovered.

HPV (GARDASIL) Side Effects Report #338434
HPV (GARDASIL) vaccine side effect was reported on 01/27/2009. Female patient, 22.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Fatigue, "approximately 3-6 wks after vaccination number 2 in september 2008. i had migraines, nausea, vomitting, fatique with no probable cause that lasted 3-4 times a week for about 3 months. followed by severe sob with no probable cause in jan 2009. i recieved vaccine number 3, 3 days ago and pain and redness at injection site.shortness of breath continues. no other symptoms have occured since 3rd vaccination" nonenonequit taking all other medications and symptoms still persisted. lab work was done to draw igE levels to diagnosis shortness of breath as an allergic reaction. results were negative. no known cause of shortness of breath have been discovered . During the same period patient was treated with adderall 20 mg xr and femcon fe. Patient recovered.

HPV (GARDASIL) Side Effects Report #338733
HPV (GARDASIL) vaccine side effect was reported on 02/01/2009. Female patient, 16.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Fatigue, "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" none (never been ill) very healthy until GARDISLNever been ill"Spinal Tap protein 159 very high. Labs and Diagnostics: CSF protein increased, then repeat CSF WNL. Anti-thyroid peroxidase Ab 107 (H). TSH WNL. T4 WNL. EEG abnormal x 3. Lipase increased. ANA 1:80. Lupus anticoags (-)." . During the same period patient was treated with none at time of vaccinaion. Patient was hospitalized Patient recovered.

HPV (GARDASIL) Side Effects Report #338868
HPV (GARDASIL) vaccine side effect was reported on 02/02/2009. Female patient, 14.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Fatigue, "Information has been received from a registered nurse concerning a 14 year old female patient who on 16-OCT-2008 was vaccinated with the first dose of GARDASIL (lot# 659184/0843X) 0.5ml intramuscularly. Subsequently the patient developed sharp, intermittent abdominal pain, which resolved without treatment in an unspecified length of time. On 18-DEC-2008 the patient received her second dose of GARDASIL (lot# 659184/0843X) 0.5ml intramuscularly. On 22-DEC-2008 patient developed intense abdominal pain as well as pain in her lower extremities. Patient's parent sought medical attention by calling the health department. The nurse is unsure if the pain had resolve at the time of this report. On 05-JAN-2009 patient was hospitalized with a diagnosis of pneumonia and was discharged on 07-JAN-2009. This is one of several reports received from the same source. Additional information has been requested. 3/23/09 Received ER & Clinic medical records of 1/19-2/26/2009. FINAL DX: constipation; chronic abdominal pain Records reveal patient experienced crampy intermittent severe abdominal pain & nausea since 10/08 which had worsened in 12/08 & now included muscle tenderness when seen in ER 1/19/09. Had been using narcotic pain meds, dx w/constipation, & tx w/laxative. Had missed several days of school due to pain & the pain would awaken her at night. Seen in GI clinic 1/19/09. Tx w/laxative & enema w/resolution of abd pain. Psych counseling started. RTC 1/26 dx w/functional dyspepsia & meds adjusted. RTC 2/4/09 w/right back/shoulder pain, vomiting, HAs, abdominal pain improved, classes 1/2 days & exhaustion when completed. RTC 2/26 w/20# weight gain, continued missed school although abdominal pain & HA less but continued daily." "Unknown PMH: T&A. Tension HAs. Allergy: PCN, rash. Family hx: IBS, SLE, herpetic whitlow, CNS glycolysis."Unknown LABS: Abdominal US neg. CT abdomen c/w pneumonia. KUB revealed constipation. Upper endoscopyWNL. Throat c/s neg. . During the same period patient was treated with Unknown. Patient was hospitalized Patient recovered.

HPV (GARDASIL) Side Effects Report #338911
HPV (GARDASIL) vaccine side effect was reported on 02/03/2009. Female patient, 16.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Fatigue, "Severe, chronic headaches that began very soon (within days) after first vaccination of Gardasil. Headaches became progressively worse and currently continue daily- one year later. Referral was made for vision testing, CT Scan and MRI, with no underlying cause of headaches determined. Numerous different prescription drugs were prescribed with no effect until current prescription, taken twice daily, was found to help subdue the headaches- though they have not been eliminated. At their worse, the headaches were debilitating- rendering my daughter unable to function at school with some days missed and numerous visits to the nurses office and then to the doctors office. At home, she would just curl up into a ball many days- unable to function whatsoever. The headaches begin when she wakes in the morning and persist throughout the day- every day. 3/13/09 OV dated 12/24/07 received from PCP for 16 yr WCC. Impression: Acne. Sent to derm. Left SI joint pain and R lower rib tenderness. HPV vax given. 3/16/09 Neurology consults received dated 3/14/2008 to 2/2/2009. Initially seen 3/14/08 for c/o 8-9 wk hx of H/A. Pt reports double vision, dizziness, nausea and lightheadedness with H/A. Recent 6lb weight loss. PE WNL. DX: Chronic Tension H/A. Rx meds. F/u 6/2/08 with no improvement,H/A now daily. Meds increased. F/u 8/1/08 H/A now with photophbia and nausea. 8/8/08 Mom reporting memory difficulties x several weeks. 9/2008 started Cymbalta with some improvement in H/A, however having diarrhea and tiredness. Changed to Zoloft." nonenone PMH: none"Vision screening, CT Scan, MRI, blood tests. Labs and Diagnostics: MRI/MRA brain WNL. EKG abnormal-borderline QT wave." . During the same period patient was treated with Minocycline. Patient recovered.

HPV (GARDASIL) Side Effects Report #339170
HPV (GARDASIL) vaccine side effect was reported on 02/06/2009. Female patient, 20.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Fatigue, "Patient fainted immediately after first shot. Has experienced extreme fatigue,memory loss, trouble concentrating and after the third shot started experiencing seizures. 2/13/09 MR received for multiple DOS. Pt seen in ER 4/14/08 following apparent seizure. Pt found unresponsive in bed. Difficult to arouse and confused. Post ictal upon arrival to ED. Small lac on lip. Later, a H/A. Neuro consult with PE (+) for epigastric tenderness and tenderness of the paracervical and shoulder muscles and intrascapular region. Event suggests nocturnal seizure. Returned 7/20/08 following grand mal seizure in bed. Post ictal upon arrival in ED. Both seizures following start of new antidepressant. Impression: Breakthrough seizure. Returned 11/14/08 with c/o shakiness, lip and chin quivering and an abnormal sensation like being unable to feel touch. Now having seizures every few weeks. Recently has been feeling ill, with face flushing, muscle aches and joint cracking. Final impression: Paresthesia and tremor. Seizure d/o. 3/11/09 Neuro consults received beginning 5/12/2008-12/29/08. Records reveal nocturnal seizure 10/15/08 where pt bit tongue. Seizures seem to be around time of menses. Pt c/o episodic dizziness. Neuro exam WNL. Started on Lamictal. Seizure 11/14/08. H/As in good control on Lamictal. 3/17/2009 MR received from PCP. Pt seen 4/18/08 with multiple c/o since about 10/2007. Recently hospitalized above for syncope/seizure. Since 10/2007 pt not acting herself, grades have dropped, diffuse H/A, overwhelming fatigue, puffy face. Seen in 6/08 with anxiety, fatigue. Requests meds for ~nerves~-given. Assess: Abnormal results thyroid funtion study, syncope and collapse, anxiety state. By 8/08 feeling dizzy, nauseated with dry mouth." nonsPMH: Anxiety & depression/ Bipolar d/o. EIA. T&A. Ear tubes. Allergies: sulfa. Ceclor."MRI, CAt scans, ambulatory EEG, thyroid tests,blood tests. Labs and Diagnostics: Ambulatory EEG (+) for frontotemporal slowing. MRI brain (+) for mesial temporal lesions bilaterally. ? mesial temporal sclerosis. Head CT WNL. Thyroid s" . During the same period patient was treated with birth control pills lexapro. Patient was hospitalized Patient recovered.

HPV (GARDASIL) Side Effects Report #339178
HPV (GARDASIL) vaccine side effect was reported on 02/09/2009. Female patient, 25.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Fatigue, "I have lost at least 25% of my hair. I have never experienced this type of hair loss before the shot, and am not under any major stress. I had my last shot about one year ago, and have noticed a lot of shedding of my hair since then. It is just now to the point that other people are noticing how wide my part is getting. Not to mention the fact that I have had other strange symptoms. Sometime after my second shot, I ended up in the hospital with what the doctors called a ~panic attack~. I have no previous history of panic attacks and was not under any real stress at the time. Furthermore, I have had extreme headaches, near fainting spells with partial loss of vision for a few hours at a time. To add to that, I have developed immunity deficiencies. Before this vaccine, I was perfectly healthy. Now, I have spent hundreds and hundreds of dollars trying to figure out what is wrong with me. This is physically and emotionally damaging, and I hope no one else has to experience this. 2/11/09 Received ER medical records of 8/23/2007. FINAL DX: panic attack; possible med side effect Records reveal patient experienced shakiness, difficulty swallowing with sudden onset after taking bactrim for facial infection. Felt facial swelling. Tx w/antihistamine, improved & d/c to home. 3/10/2009 Received PCP medical records of 1/29/08-1/14/2009. FINAL DX: Records reveal patient experienced: asthma, sinus HA, chest congestion, cough, fever, body aches, URI, asthma exacerbation, BCP use, tension & difficulty relaxing, weight loss, feeling cold, anxiety, fatigue, conjunctivitis, HA w/temporary left lateral vision loss 11/08, alopecia 12/08. Tx w/meds." none"Asthma, allergies (not to food or medications)""Had a normal blood test before shot, and after shot tested for immune deficiencies. LABS: CT head WNL., ANA 1:40." . During the same period patient was treated with "Yasmin, albuteral, singular". Patient recovered.

HPV (GARDASIL) Side Effects Report #339390
HPV (GARDASIL) vaccine side effect was reported on 02/10/2009. Female patient, 15.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Fatigue, "Pt seen for headaches on 1/21/09 - Seen again on 2/7/09 when mother told dr she is concerned this is related to the HPV vaccine. got related information from the internet 2/13/09 Received PCP medical records of 1/21-2/10/2009. FINAL DX: tension/stress HA Records reveal patient experienced HA on 1/21 occurring 4-5x/wk over 2 mo period. Usually starts in afternoon. Tiredness, stomach pain. Tx w/meds. RTC 2/7 w/worse HA unrelieved by meds along w/joint pain, low energy, stomach ache. CT scan & labs ordered." NoneNoneHead CT Scheduled for 2/13/09 . Patient recovered.

HPV (GARDASIL) Side Effects Report #339457
HPV (GARDASIL) vaccine side effect was reported on 02/11/2009. Female patient, 15.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Fatigue, "Developed symptoms of severe headache, fatigue, dizziness, abnormal vision and excessive sleeping on about 5/2/2007, 5 weeks after receiving HPV #1 and about 1 week after diagnosis of acute Group A strep throat on 4/26/2007. She continued to have prolonged symptoms and MRI of brain was performed on 5/23/07 and was consistent with Acute disseminating encephalomyelitis. She was hospitalized for several days and treated with IV steroids and bed rest. She had a prolonged convalescence but for the most part all symptoms had completely resolved by August 2007 except for continued headaches for which she takes amytriptline rather regularly. She continues to have psychologic issues, but these pre-dated HPV vaccine and I do not think they are the result of HPV. She sees a psychologist regularly. She has not received any further HPV due to concern about possible connection with her A.D.E.M. 2/24/09-records received for DOS 5/30-6/2/07-DC DX:post lumbar puncture headache. Acute disseminated encephalomyelitis (ADEM). One month prior received treatment for infectious cerebellitis and a diagnosis of ADEM 2-3 weeks prior to admission. Prior to lumbar puncture C/O confusion and disorientation. Presented with vomiting and headache. Lower back pain. Blood patch performed. Eye consult 5/23/07-C/O sudden onset horizontal diplopia, dizziness and movement of the environment. 3/23/09-additional information recieved-presented on 5/30/07- with C/O headaches after lumbar puncture. 2-3 weeks ago developed diplopia and a gait imbalance," None"Adjustment reaction with depressed mood 2/24/09-records received-PMH: Chronic tension headaches, neck and shoulder tension. Headaches for many years but now worse. Double vision. Stated always had tracking issues with reading. Strep throat 5/7/07.Allergy to penicillin."MRI of brain consistent with A.D.E.M. 4/24/09-records received-MRI abnormal signal in brainstem without regional mass effect. Compatible with demyelinating disease. T2 signal abnormality. MRI showed ADEM. Follow-up MRI yesterday showed imp . Patient was hospitalized Patient recovered.

HPV (GARDASIL) Side Effects Report #339525
HPV (GARDASIL) vaccine side effect was reported on 02/12/2009. Female patient, 16.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Fatigue, "12/17/08 mom took patient to ER for nausea and vomiting. 12/19/08 mom took patient to ER for shortness of breath. Diagnosed with acute myeloid leukemia. 2/18/09 Received ER medical records of 12/17/2008. FINAL DX: vomiting w/o dehydration. Records reveal patient experienced N/V x 3 days, no BM x 2 days. Able to tolerate oral fluids. Tx w/antinausea meds & d/c home on additional antinausea meds. 3/23/09 Received hospital medical records of 12/19/08-remains inpatient. FINAL DX: acute myeloblastic leukemia; respiratory failure; severe thrombocytopenia & anemia w/severe neutropenia; pneumonia; renal failure. Records reveal patient experienced flu-like symptoms, bone aching, bruising & petechial rash, pale, fatigue, SOB, low grade fever & abdominal pain w/vomiting x 3-5 days w/conjunctival hemorrhage. Developedencephalopathy, respiratory distress, renal failure, tumor lysis syndrome, metabolic derangements, ARDS, labile BP. Heme/onc, Pulm, ID, Nephro consult. Admitted PICU, intubated followed by tracheostomy, initially CVVH followed by peritoneal dialysis, multiple transfusions, antibiotics, chemotherapy. Developed pancytopenia secondary to chemotherapy. 10/1/09 Hospital discharge summary received DOS 12/19/08 to 8/4/09. Additional information abstracted. Assessment: Acute myeloid leukemia. Acute Respiratory distress syndrome with pulmonary fibrosis, refractory thrombocytopenia, recurrent infections and bacteremia, muscle contractures, renal insufficiency. Patient on TPN. Chemotherapy. Physical therapy. Discharged to rehab center. 11/5/2009 MR dated 7/30 is aprogress note stating that patient is in remission per bone marrow done 7/1/2009. Patient had a tracheostomy 2/2009 and now wears a trach collar. Patient underwent Chemotherapy x 3 cycles with remission. Patient is off TPN 7/2009 and is eating and drinking. Patient still has low paltelet and hemoglobin counts and is transfused for this on a regular basis. Patient is now undergoing intense rehab." None reported"Asthma; ADHD; MR PMH: intrauterine growth retardation, NICU, developmental delays, learning disability, amenorrhea.""LABS: CXR w/infiltrates. WBC 170,000, Hgb 4.1(L), plts 10K (L). Potassium (H), Uric acid 10.5(H). Creatinine 1.3. Urine c/s (+) enterococcus faecium." . During the same period patient was treated with CLONIDINE; ALBUTEROL; MONTELUKAST. Patient was hospitalized Patient recovered.

HPV (GARDASIL) Side Effects Report #339662
HPV (GARDASIL) vaccine side effect was reported on 02/16/2009. Female patient, 22.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Fatigue, "Fever, headache, nausea, joint pain, unusual tiredness/weakness, aching muscles, muscle weakness, bad stomach ache. 2/18/09 Received vaccine records & PCP medical records of FINAL DX: viral syndrome & vaccine allergic reaction Records reveal patient experienced left arm pain s/p vaccination w/fever, HA, facial swelling, difficulty swallowing, gen aching, nausea, & seen in ER 2/6/09. Tx w/IVF & meds, imiproved & d/c to home. Missed 3 days of school." NANA PMH: abnormal pap smear; LEEP/LEETZ; bilat breast augmentation; allergies/hay fever; GERD; contraception.Urine sample. . During the same period patient was treated with Zovia. Patient recovered.

HPV (GARDASIL) Side Effects Report #339697
HPV (GARDASIL) vaccine side effect was reported on 02/16/2009. Female patient, 14.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Fatigue, "Information has been received from a Registered Nurse concerning her daughter (a 15 year old female) who in August 2008 was vaccinated with the third dose of GARDASIL (lot number was not available). The patient experienced leg weakness, dizziness, fatigue and syncope after receiving her third dose of vaccine. At the time of reporting the patient was not recovered. Follow-up AE Information was received from the Registered Nurse by phone concerning her daughter with no pertinent medical history and drug allergies who was vaccinated with her third dose of GARDASIL in April 2008 (not August 2008 as previously reported). Date of birth of the patient is 19-JUN-1993. Patient is not pregnant. Lot #s of GARDASIL are unspecified. Her symptoms began in October 2008. In addition to leg weakness, dizziness, fatigue and syncope the patient has also been experiencing seizure-like activity. No other vaccinations was administered with GARDASIL. Patient is on AVIANE birth control. The patient has seen a neurologist and has had an EEG, EMG of lower extremities and MRI of brain, MRI of abdomen and lab work. All tests have all come back negative. Dose 1 was administered on an unspecified date and dose 2 was administered on 09-SEP-2007. The patient's symptoms are getting worse. The syncope and seizure-like activity are occurring more often. No hospitalization, not life-threatening, not a significant disability. No treatment and no medication have been prescribed at this point. Upon internal review, seizure-like activity was determined to be an other important medical event. The patient sought medical attention. Additional information has been requested. 2/24/09 Received PCP medical records of 11/7/08, Records reveal patient experienced abdominal pain, dizziness, numbness & urinary incontinence x 1. Refered to Neuro. 3/4/09 Received Neuro medical records of 11/18/2008-2/12/2009. FINAL DX: right peripheral vestibular dysfunction, vestibular neuronitis & restless leg syndrome Records reveal patient experienced episodes of diseq" "None PMH: aching, cramping,numbness, tingling of LEs w/urge to move legs for several years, esp at night. Depo-provera./""Electroencephalography, 10/??/08, negative; Electromyography, 10/??/08, for lower extremities: negative; Magnetic resonance, 10/??/08, for brain: negative; Magnetic resonance, 10/??/08, for abdomen: negative; Laboratory test, 10/??/08, nega" . During the same period patient was treated with Aviane. Patient recovered.

HPV (GARDASIL) Side Effects Report #339757
HPV (GARDASIL) vaccine side effect was reported on 01/16/2009. Female patient, 25.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Fatigue, "Weakness, nausea, tiredness, confusion, off balance AM & PM, racing thoughts and actions in the AM. 2/25/09 MR received. HPV vax 12/2/08 and 1/5/08. Pt to be seen for cognitive eval on 1/23/09, but pt was 45 minutes late. Pt c/o dizziness, weakness and difficulty concentrating. Referred to ER for physical complaints. Not seen in ER. Consult (+) for hyperreflexia of R upper extremity. Sent for MRI. 3/9/09 Additional records received. Psych consult states pt has hx of depressive sx since 2003. Recently d/c antidepressant. Started on another recently. Exam with some psychomotor slowing and depressed mood. DX: Dysthymia. Cluster B personality features. Arthralgia of knees. Anemia-on iron. Later eval reports sx may be r/t Lupus dx since MRI (-)" NoneDepression. PMH: Lupus. Mild cognitive impairment. Tinnitus. Headache. PTSD. Major depression recurrent. R knee arthralgiaLabs and diagnostics: MRI brain (-). X-ray spine (+) for dextroscoliosis. Knee X-ray (+) for ? quadreiceps tendinosis. ESR 27. . During the same period patient was treated with None at the time. Patient recovered.

HPV (GARDASIL) Side Effects Report #340321
HPV (GARDASIL) vaccine side effect was reported on 04/07/2009. Female patient, 26.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Fatigue, "Information has been received from a registered nurse concerning a 26 year old female with polycystic ovarian syndrome, a history of thoracic sympathectomy for excessive sweating, and not known drug allergies, who on 27-JAN-2009 was vaccinated with a 0.5 mL first dose of GARDASIL (lot # 1423X), intramuscularly. Concomitant therapy included MIRCETTE and prenatal vitamins (unspecified). That evening the patient had episodes of diarrhea, flu like feeling, fatigue, achiness and chills. The symptoms persisted and the patient stated that she started to develop tingling in her lower legs and feet on 29-JAN-2009. The registered nurse requested that the patient took her temperature and it was 98.4 degrees F. The patient sought medical attention through a phone call. At the time of this report the patient had not recovered. Additional information has been requested.4/8/09records received-presented in ED on 2/2/09 with C/O pins and needles in legs and hands s/p gardasil vaccine. Paresthesia and weakness lower extremities. Mild shortness of breath. PE RLE 4/5 LUE 4/5. No actual motor weakness. DX: Mild Guillain Barre secondary to vaccination. This is in follow-up to report (s) previously submitted on 2/13/2009. Follow up information received on 19-FEB-2009 stated that the patient received a first dose of GARDASIL (lot # 1423X), intramuscularly into the left deltoid on 27-JAN-2009 at approximately 12:00. The patient had a sympathectomy in 1999 for excessive sweating. It was also reported that the patient called to the physicians office on 29-JAN-2009 complaining of fatigue, diarrhea and flu like symptoms starting a few hours after administration of GARDASIL. The patient also complained of ~tingling of feet~. On 01-FEB-2009 the patient called for increasing numbness on legs, the patient went to E.R. on 02-FEB-2009 for numbness and saw the neurologist who prescribed NEURONTIN. Follow up information received on 27-FEB-2009 from the physician's secretary; she provided the patient's last name. It was also stated that" Polycystic ovarian syndromeExcessive sweating 4/8/09-records received-PMH: T2-T4 sympathectomy with chronic sweating/chills."temperature measurement, 98.4 degrees F 4/9/09-records received-CBC WNL." . During the same period patient was treated with MIRCETTE; vitamins (unspecified). Patient recovered.

HPV (GARDASIL) Side Effects Report #340329
HPV (GARDASIL) vaccine side effect was reported on 02/13/2009. Female patient, 14.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Fatigue, "Information has been received from a nurse practitioner concerning a 15 year old female patient who in November 2006, was vaccinated with GARDASIL IM for her first dose. The patient experienced flu like reactions after the first dose such as headache, fever, nausea and dizziness. The patient received the second dose of GARDASIL IM on 09-JAN-2007 and experienced sore arm (unspecified which arm). The patient received the third dose of GARDASIL IM on 24-MAY-2007. The patient was having unusual joint pain (all over but mostly in the knees), excessive fatigue, moments of shortness of breath, lots of muscle weakness, period of stomach aches, dizziness (may have been related to fluid in the ears), and chest pain on exercising. It was unspecified the time period all these symptoms occurred. The patient remembered having stomach problems but not sure as to the timing of the onset of the problem in relation to the third dose. The patient was last seen in the office on 22-JAN-2009 and was not doing any better. The patient had also sought medical attention by phone calls and office visits. Additional information has been requested. 3/6/09 Received PCP medical records of 4/12/2008-1/27/2009. FINAL DX: polyarthralgia Records reveal patient experienced feeling feverish, sore throat, fall from horse w/o LOC or injury then developed frontal HAs, LUQ pain after meals, fatigue. RTC 10/08 w/left hip pain, dx w/greater trochanter tendinitis w/early ileatal band syndrome. RTC 12/08 w/dry nonproductive cough x 2 wks, dx bronchitis & tx w/oral antibiotics. RTC 1/09 w/recurrent cough, difficulty breathing, fatigue, muscle aches, HA & dizziness. Dx w/recurrent bronchitis. RTC 1/14 w/persisting HA, resolved dizziness & persistent muscle/joint aching. RTC 1/27/09 & reports having flu-like s/s after initial HPV vaccine. Referred to Neuro when CT head neg but no record available." Unknown PMH: reflux."head computed axial, negative; diagnostic laboratory, metabolic panel, negative; complete blood cell, negative; Lyme disease assay, negative; Epstein-Barr virus, negative LABS: rapid strep (-). CT head, CXR WNL. ANA 9(H). CBC & CMP WN" . During the same period patient was treated with Unknown. Patient recovered.

HPV (GARDASIL) Side Effects Report #340481
HPV (GARDASIL) vaccine side effect was reported on 02/13/2009. Female patient, 21.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Fatigue, "Information has been received from a practice manager concerning a 21 year old female with no pertinent medical history, drug reactions or allergies who on 20-JAN-2009 was vaccinated intramuscularly with a first 0.5 ml dose of GARDASIL (Lot#660616/0570X). Concomitant therapy included YAZ. On 20-JAN-2009, ~within 30seconds of receiving her first dose of GARDASIL vaccine~, the patient fainted. she revived after a few minutes her fainted again ~15 minutes later~. It was reported that the patient revived and was given juice and crackers, and left the office in stable condition. A follow-up phone call was placed to the patient on 21-JAN-2009 and the patient stated that she felt ~tired and weak~. No lab diagnostic studies were performed. At time of the report, 21-JAN-2009, the patient had not recovered. Additional information has been requested." NoneNone . During the same period patient was treated with YAZ. Patient recovered.

HPV (GARDASIL) Side Effects Report #340333
HPV (GARDASIL) vaccine side effect was reported on 02/20/2009. Female patient, 19.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Fatigue, "Information was viewed on the Internet concerning a 19 year old patient who in approximately April 2008 (10 months ago), was vaccinated with the first dose of GARDASIL. Second dose was administered (unspecified date). The mother of the patient reported that prior to first shot, the patient was healthy and active. After the vaccination the patient's back started hurting immediately and about three weeks after the first dose of GARDASIL the patient had her first seizure. After the second dose of GARDASIL the seizures, increased, as did severe stomach pain experienced, fatigue, headache, joint pain, vision problems, hair loss and bleeding gums. The mother reported that the patient has been hospitalized four times, there has been multiple ambulance calls daily seizures, several incidents of cluster seizures where she stopped breathing and turned blue. The mother reported that patient seemed to be improving as time goes by. Therapy with GARDASIL was discontinued. Attempts to verify the existence of an identifiable patient have been unsuccessful. No further information is available." UnknownUnknown . Patient was hospitalized Patient recovered.

HPV (GARDASIL) Side Effects Report #340584
HPV (GARDASIL) vaccine side effect was reported on 02/23/2009. Female patient, 24.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Fatigue, "Patient calls VHC x 3 in past week. ~Just don't feel like myself; very tired, achy, constant HA, nodes on side of neck and under chin are enlarged.~ Reports chills, general malaise, ongoing, constant frontal HA with changes in vision- not as sharp with glasses on and blurry with glasses off, photophobia, some noise sensitivity, slight nausea (negative prior hx migraines), decreased appetite, loose stools s/p GARDASIL #1 on 02-11-09. Seen by PCP on 02-20-09, who Dx'd as ~Acute Cervical Lymphadenitis.~ Bloodwork: CBC with DIFF, CMP, ESR, HIV-1 AB, RPR, Reticulocytes, TSH sensitive ALL WNL with exception of slightly decreased Hgb of 11.7 - patient states she was at the end of her menstrual cycle when the labs were drawn. HIV-1 AB and RPR results pending-advised patient to call PCP for results. Patient is very anxious because her cousin was recently dx'd with HIV. Patient is currently not sexually active- her husband, AD military spouse, is deployed at present." None"NKDA. Patient had recent (10FEB09) Allergy work-up, which was negative for environmental allergens per skin testing. Normal Pulmonary Function testing. Dx was vasomotor rhinnitis."CBC with Diff; ESR; TSH-sensitive; CMP; HIV-1 AB; RPR . During the same period patient was treated with Ibuprofen 800 mg po tid with food; EXCEDRIN prn for HA's; OTC Super B-Complex. Patient recovered.

HPV (GARDASIL) Side Effects Report #340807
HPV (GARDASIL) vaccine side effect was reported on 02/26/2009. Female patient, 16.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Fatigue, "chronic debilitating headaches, chronic diahrrea, severe back & abdominal pain, tingling in hands and feet,numbness in hands & feet, stabbing pain in lower legs and feet, inability to stand, inability to walk, difficulty breathing, swollen lips, chest pain in conjunction with neck pain, loss of hair, chronic debilitating fatigue, nausea, vomiting, short term memory loss, inability to concentrate, stares off in the distance for long periods of time. These started right after the vaccination and continue to this day & have made her life as she knew it unmanageable. She can no longer attend school. Numerous trips to her pediatrician, blood tests, urine test, stool tests, emergency room visits, referred to neurologists, nutritionist. No one knows how to treat her. There is no treatment apparently. 3/16/09 Received consult records of 2/24/2009. FINAL DX: probable chronic fatigue syndrome, possibly exacerbated by recent EBV infection; reactive depression; likely vasovagal episodes; possible anxiety disorder. Records reveal patient experienced fatigue, nausea, numbness/tingling of hands/feet, HA, neck pain, intermittent diarrhea, chest pain w/SOB & heart pounding, intermittent difficulty walking, difficulty concentrating, decreased appetite, insomnia, apathy, moody, irritable. Approx 1 wk after initial HPV & Depoprovera injections, 11/12/08, developed waxing/waning fatigue which escalated to missing school in Dec & Jan. Suggested antidepressant & counseling. 3/9/09 Received PCP medical records of 2/2007-3/2/2009 included ER records of 2/9/2009. FINAL DX:none provided Records reveal patient experienced good health on 11/12, received depo-provera 1st dose along w/HPV #1. RTC 2/11 s/p ER visit 2/9 for chest pain, cough, runny nose, phlegm congestion. Parent reported back pain, hand tremors, leg pain, leg swelling, back pain, dizziness, joint stiffness, decreased concentration, fatigue, intermittent diarrhea, nausea since 11/08. Missed several days of school. Developed leg heaviness, gait disturbance," none"none PMH: acute pharyngitis, HA, acute sinusitis, cough, acne vulgaris tx w/minocin, abdominal pain, diarrhea. Family hx: depression, suicide.""ESR, ASO, FT4, TSH, ANA TITER, ANTI-DS-DNA, EBV AB PROFILE ACT WKST: FANA, STOOL, URINE, CARDIAC ENZYMES, EKG, CHEST X-RAY, CAT SCAN - NEURO TESTING IS NEXT WEEK. LABS 2/18/09: ASO 161(H). EBV IgG (+), nuclear antigen neg, IgM (+). ESR 3" . During the same period patient was treated with none. Patient recovered.

HPV (GARDASIL) Side Effects Report #340931
HPV (GARDASIL) vaccine side effect was reported on 02/12/2009. Female patient, 13.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Fatigue, "Persistent LUQ pain, fatigue and weight loss since administration of first GARDASIL vaccination. Pt and pt's mom did not report these symptoms. Pt received second dose of GARDASIL on 10/10/08 - mom reports original sign and symptom much worse with severe abdominal pain. Symptoms reported 10/30/08. Monospot and pain/ fatigue persisted - referred to GI. 4/9/09 MR received from PCP. Well check 7/11/08. HPV#1 given (0279X). Returned for 2nd HPV shot 10/10/2008 with lot #U2687AP recorded (see vax rec). Returned 10/30/08 with c/o 3 wk hx of nausea, pallor, sore throat, H/A and LUQ pain. Feeling tired and dizzy. PE (+) for palpable ridge of spleen, LUQ tenderness. Sent for CT. Returned 11/6/08 with report of one episode of passing out. Out of school all week. Assessment: Mono. Seen 11/24/08 for Mono with viral pharyngitis. By 12/4 08 parent reporting pt still ill with viral URI, still fatigued. Recheck 12/25/08. Reporting more frequent dizzy spells. No LOC. PE (+) for LUQ tenderness. Seen 1/13/09 for sore throat, sinus congestion, and R ear pain x 2 weeks. Still with abdominal tenderness. Some good days some bad. Referred to GI. 4/14/09 GI consult received. Initially seen 2/209 with c/o 3 month hx of abdominal pain, tiredness, fatigability, chills, H/A fever, lightheadedness and LUQ discomfort. Now daily sx with ~ 10lb weight loss. ROS additionally (+) for malaise, night sweats, recurrent sinus congestion, joint pain and stiffness, balance issues, dizziness, and new onset acne. PE (+) for epigastric tenderness. Assess: LUQ pain-discomfort of ? etiology. S/P mononucleosis syndrome. F/U 3/12/09 with continued sx. Impression: Chronic LUQ pain and nausea ?? etiology." "amoxicillin. PMH: Allergies to Pertussis, Amox. L ankle pinning.""CT of abdomen (neg); CBC; CMP; amylase; lipase. Labs and Diagnostics: Monospot (+). CBC WNL. CMP, amylase and lipase WNL. Lipase later up to 242 (H) by 2/2/09. TC (-) for strep. CT abdomen WNL. BE WNL. Duodenal bx WNL. Helicobacter (-)" . Patient recovered.

HPV (GARDASIL) Side Effects Report #340882
HPV (GARDASIL) vaccine side effect was reported on 02/28/2009. Female patient, 17.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Fatigue, "AFTER FIRST GARDASIL VACCINE (administered 9/13/06): experienced dizziness, light-headed, nauseous, headaches, leg cramps, and shooting leg pain. AFTER SECOND GARDASIL VACCINE (administered 11/13/06): experienced same symptoms after first dose plus hair loss, abdominal bloating, menstrual cycle stopped, weakness, poor circulation. AFTER THIRD GARDASIL VACCINE (administered 3/13/07): experienced all symptoms listed above plus excessive hair loss, pale/purple skin, always cold, loud ringing in ears, extreme digestive problems, stomach pain, gastrointestinal discomfort, chronic constipation, joint pain, facial swelling, chronic fatigue, irritability, easily agitated, extreme weakness and all-over muscle fatigue (with difficulty in walking, talking, moving, etc.). TREATMENT: had to seek alternative medicine doctors to receive nutritional supplementation because other doctors could do nothing for me. Recently have been referred to a clinic. (scheduled appt. for 3/30/09). 3/18/09-records received for DOS 5/18-5/20/08-DC DX: Chronic constipation. Exercise induced asthma. Cyanosis. Pancytopenia. Presented to ED with increased generalized weakness and constipation since 2/08.Taking a Chinese herbal formula for chronic fatigue astra lsatis. Possibility of viral syndrome secondary to hepatitis C. PE: differential in pulses bilaterally, cyanotic in extremities pulse ox O2 saturation 87% at exercise but increased at rest. Follow-up: Leg pain, numbness, stiffness, partial organ failure, anemia low platelets, cardiac arrhythmia, low body temperature, EBV onset, Hep C onset, UTIs, pancreatitis, amenorrhea, melanosis coli, gout, boils, Baker's cyst, swollen glands hypothyroidism, hypoglycemia, chronic somnolence episode tachycardia, dysphagia, orthopnea, thrombocytopenia." none"none 3/18/09-records received-Recurrent sinusitis, status post rhinoseptoplasty. hepatitis C. Questionalbe history of Epstein-Barr virus infection. Gastroesophageal reflux disease.""Diagnosed with: Thrombocytopenia, Pancytopenia, Ammenorrhea, Hypothyroidism, Anemia, low blood pressure, Autoimmune Disorder, partial organ failure, digestive disorder, Epstein Barre, Orthopnoea, hormonal imbalance, urinary tract infection," . During the same period patient was treated with none. Patient was hospitalized Patient recovered.

HPV (GARDASIL) Side Effects Report #340900
HPV (GARDASIL) vaccine side effect was reported on 02/27/2009. Female patient, 16.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Fatigue, "Information has been received from a physician via an email from a consumer concerning the consumer's 16 year old daughter who on 20-MAY-2008 was vaccinated with the third dose of GARDASIL (lot no. and route not reported). The consumer reported that in the summer of 2008, the patient started to complain of constant fatigue, had fainting spells and random bouts of aches and pains. On 11-SEP-2008, she was sent home from school with complaints of headache, spine pain, confusion and symptoms of bladder infection. She was given antibiotics by the gynecologist and was sent home. The consumer reported that the next day (12-SEP-2008) the patient woke up screaming for help as she couldn't feel her arms and legs, was gasping for air, vomiting, had severe back pain and fever. The mother reported that at the emergency room (ER) the patient was given antibiotics and sent home as she was told she ~may have passed a kidney stone~. It was reported that over the next two weeks her health was deteriorating and after her fourth visit to the ER she was finally hospitalized for the next ten days. Over the course of her stay the patient was seen by teams of doctors from Neurology, Rheumatology, Infectious disease, Endocrinology, Adolescent medicine, Urology, and Cardiology. The consumer reported that the patient endured two spinal taps, many MRI, CAT scan, sonograms, ultrasound and blood workups until ~her body could no longer emit any blood~. The patient was on morphine drip for severe headaches, liquids for rehydration, PERCOCET for allover pain and two and nausea medication for severe vomiting and acid reflux. The patient was checked for Lyme disease, meningitis, lupus, fibromyalgia chronic fatigue Hoshimoto's disease kidney disease and multiple sclerosis and everything showed up negative. The patient became so sleep deprived because her heart rate was in the 30 range that a monitor constantly kept her awake. The patient started hallucinate and was developing blood clot in her legs from lack of use. The mother stated that since the" Unknown"cardiac monitoring, heart rate is in the 30 range" . During the same period patient was treated with Unknown. Patient was hospitalized Patient recovered.

HPV (GARDASIL) Side Effects Report #340901
HPV (GARDASIL) vaccine side effect was reported on 02/27/2009. Female patient was vaccinated with HPV (GARDASIL). Patient symptoms: Fatigue, "Information has been received from a physician via an email concerning a female who was vaccinated with a dose of GARDASIL. The consumer reported that a ER nurse stated that the patient was admitted to the hospital with the same symptoms as the consumer's daughter down to constant fatigue, inability to walk, severe back pain, spine pain, symptoms of bladder infection, fainting spells, gasping for air, acid reflux, hallucination, headache, sleep deprivation, not feeling of her arms and legs, bouts of aches and pain, fever, blood clots in her legs, vomiting, dehydration and all over pain. It was reported by the nurse that this patient was finally diagnosed with a severe reaction to GARDASIL. Attempts are being made to verify the existence of an identifiable patient and reporter. Additional information will be provided if available. This is one of two reports from the same source. Additional information has been requested." UnknownUnknown . During the same period patient was treated with Unknown. Patient was hospitalized Patient recovered.

HPV (GARDASIL) Side Effects Report #340952
HPV (GARDASIL) vaccine side effect was reported on 02/15/2009. Female patient, 16.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Fatigue, "My daughter received her 3rd injection of GARDASIL vaccine on Feb. 9th 2009. She had severe headaches ever since. We took her to the emergency room on Feb 13th. They ran a series of tests which included a brain scan. Nothing abnormal showed but she never got rid of her headache. To this day she is fatigued, dizzy, has headaches, blurry vision and arm pain. These side effects were never mentioned yet when I looked on the web many people said they had the same side effects after the vaccine. I am taking her to her pediatrician tomorrow to have him evaluate her again and we will go from there." None . During the same period patient was treated with "Feb 13, 2009 emergency room treatment". Patient was hospitalized Patient recovered.

HPV (GARDASIL) Side Effects Report #340967
HPV (GARDASIL) vaccine side effect was reported on 03/02/2009. Female patient was vaccinated with HPV (GARDASIL). Patient symptoms: Fatigue, "Information has been received from a teenage female athlete (runner) via a news report who in May 2008, was vaccinated with GARDASIL. In May 2008, within days of getting the vaccine, the patient became mysteriously ill and was hospitalized. The patient said she couldn't breathe and was really fatigued. Her chest was beginning to hurt like she was having an allergy or asthma attack. In July 2008, doctors diagnosed the patient with mononucelosis. As of 19-FEB-2009, the patient had not recovered and was still too weak to run. The patient's family thinks GARDASIL was responsible, but the patient's physician's did not know if her condition was related to the vaccine or if it was a coincidence. Additional information is not expected." UnknownUnknown . During the same period patient was treated with Unknown. Patient was hospitalized Patient recovered.

HPV (GARDASIL) Side Effects Report #341212
HPV (GARDASIL) vaccine side effect was reported on 03/05/2009. Female patient, 14.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Fatigue, "Information has been received from a office manager concerning a 14 year old female patient who on 28-APR-2008 was vaccinated with the first dose of GARDASIL (Lot number 660387/1967U). On 27-JUN-2008, the patient was vaccinated with the second dose of GARDASIL (Lot number 660553/0070X) and on 24-NOV-2008 with the third dose of GARDASIL (Lot number 661764/0650X). In September 2008, the patient complained of tiredness. The patient was cultured and was positive for mononucleosis. In January 2009, the patient began to felt awful and really bad. The patient had some laboratories taken and her blood work came back as: WBC-2, platelet-150, and no leukemia. The patient was hospitalized for one week. She had since been released from the hospital. Additional information has been requested." Unknown"Diagnostic laboratory, 01/??/09, blood work: no leukemia; Diagnostic laboratory, 09/??/08, positive for mononucleosis; WBC count, 01/??/09, 2; Platelet count, 01/??/09, 150" . During the same period patient was treated with Unknown. Patient was hospitalized Patient recovered.

HPV (GARDASIL) Side Effects Report #341247
HPV (GARDASIL) vaccine side effect was reported on 02/04/2009. Female patient, 16.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Fatigue, "Ongoing dizziness, dysautonomia, fatigue. Has been treated for possible Meniere's disease and for anxiety. Recurrent MRSA skin infections since 9/2008. 3/20/09 Received PCP medical records which included hospital medical records, Neuro, ENT & Cardio consults. FINAL DX: chronic migraines; chronic dizziness; depression; anxiety; orthostatic intolerance; peripheral vertigo; active Meniere's disease, cochleovestibular; tinnitus; possible vestibular migraine; paced vertiginous syndrome; partial dysautonomia probably post viral; orthostatic intolerance grade 1. Records reveal patient experienced episodes of dizziness 9/19/07, near blacking out w/position changes. Already seeing Neuro at that time for migraines. PO fluids encouraged. RTC 11/28/07 for BCP when minocycline d/c for acne. RTC 1/21/08 w/anxiety, depression, anger x 1 year. Tx w/antidepressants & referred for counseling. RTC 5/12/08 feeling better but still anxious; meds adjusted. RTC 9/24/08 w/insect bite left inner thigh & cough. Dx w/cellulitis left leg & URI. Tx w/oral antibiotics. RTC 9/25/08 w/worsening cellulitis, dizziness, dysautonomia. Tx w/IM antibiotics & given FluMist. RTC 9/26/08 w/worsened cellulitis/early abscess & admitted to hospital 9/26-9/29/08. Tx w/Vanco & developed red man's syndrome, chest pain. C/S (+) MRSA. Recurred 10/29 & again 1/5/09 & tx w/oral antibiotics. Missed several days of school due to autonomic instability symptoms. RTC 2/20/09 w/sore throat, HA, abdominal pain, dizziness. Dx w/abdominal pain, dizziness & pharyngitis. Neuro consult 11/12/07-12/22/08. FINAL DX: chronic migraines; chronic dizziness; dysautonomia; depression; anxiety; orthostatic intolerance. ENT consult 2/1-4/21/08. FINAL DX: peripheral vertigo; active Meniere's disease, cochleovestibular; tinnitus; possible vestibular migraine; dysautonomia. Cardio consult 4/11-5/15/2008 FINAL DX: paced vertiginous syndrome; partial dysautonomia probably post viral; orthostatic intolerance grade 1; anxiety" Dizziness"Amblyopia, Migraines, dizziness, patellofemoral syndrome PMH: acne on minocycline x 2 yr; left orbital rim fracture; amblyopia; high triglycerides; dysautonomia; MRSA cellulits/abscess left thigh 9/08; tonsillectomy; PE tubes. Family hx: asthma, allergies, migraines, SLE, melanoma, DM, HTN, enlarged heart, hypothyroidism.""Normal CBC. T4 Potassium, BMP Negative mono screen. Mild intolerance to tilt table test. LABS: rapid strep neg. EKG WNL." . During the same period patient was treated with TOPAMAX. Patient recovered.

HPV (GARDASIL) Side Effects Report #341435
HPV (GARDASIL) vaccine side effect was reported . Female patient, 24.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Fatigue, "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." Asthma; ZOFRAN allergy . During the same period patient was treated with SINGULAIR; ADVAIR; ZEBETA; BCP. Patient recovered.

HPV (GARDASIL) Side Effects Report #341462
HPV (GARDASIL) vaccine side effect was reported on 03/10/2009. Female patient, 16.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Fatigue, "After getting the gardasil vaccine three weeks ago, my daughter has severe back pain, general muscle aches, fatigue and terrible headaches. She also had swelling of her mouth and lips. I am very concerned about her back problem because it is very unusual and the doctor really doesn't know what is wrong. These symptoms didn't occur until after her first dose of gardasil. SHE WILL NOT BE RECEIVING THE LAST TWO DOSES OF THE DRUG! 4/1/09-records received-office visit 2/2/09-C/O hives rash on body since 2/7/09, itchy and red-seen in ED started on prednisone. assessment:dermatitis secondary to PCN. 2/17/09 office visit C/O bad headaches every couple of days. Not eating for one week but drinking soda and caffeine. Fatigue. Assessment possible eating diorder possible cause of headaches suspect underlying mood disorder. Received Gardasil/Adacel Menactra. Referred to eating disorder clinic. Office visit 3/2/09-C/O inflammation in upper back with pain began day before and is a recurrent porblem however first time seen for the problem. Assessment muscle sprain likely secondary to month of coughing. 3/10/09-requests referral to specialist. Office visit 3/17/09 C/O hives and persistent back pain." "none 4/1/09-records received-Began 2 months ago followed by cough, runny nose, sore throat."none 4/1/09-records received-Allergies:amoxicillin.Currently being treated by Dr. at our family physician's office. . Patient recovered.

HPV (GARDASIL) Side Effects Report #341554
HPV (GARDASIL) vaccine side effect was reported on 03/11/2009. Female patient, 13.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Fatigue, "October, 2007 - Back and Hip pain Winter, 2007/08 - addition of shoulder and elbow pain, ankle pain and weakness, increase in back and hip pain - medicated with Advil/Tylenol (OTC) March, 2008 - addition of tingling and numbness in arms and legs. Shooting pains in arms and legs. Extreme exhaustion and fatigue June, 2008 - Treated with Physical Therapy and Mobic/Advil. Had MRI of Lumbar spine on 7/07/08 August, 2008 - extreme pain when running. All of the earlier symptoms were still present. Intense muscles cramps in legs and arms, especially at night. Addition of muscle cramps in hands when writing or playing piano for a very short time (10 minutes). September, 2008 - All symptoms remain. Addition of hair loss, weight loss, increase in fatigue. blurry vision. lightheadedness, dizziness 3/19/09 records received-office visit 7/1/08-multiple complaints over sometimes, Active in gymnastics, somewhat knock-kneed. C/O left hip popping in and out with activity appears to be iliotibial band phenomena. Right knee and kneecap popping in and out with activity and some tightness in tendons in back with activity. Right elbow complaints with activity. Spot on left forearm been there a few months, looks like possible pencil lead in skin. Assessment: hip problem suspect iliotibial band. Knee problem looks like patellar malalignment. Elbow problem looks like tennis elbow phenomena. Referral to sports medicine. office visit 3/16/09- No complaints." nonenone 3/19/09-records received-environmental allergies."calcium ionized, CPK, total, gammaglobulin, lyme disease AB, Tissue transglutamin, Gliadin Antibody, 25-OH Vitamin D3, ANA Cascade, HLA B27, calcium, Free T4, MAgnesium, potassium, phosphorous, CRP, TSH, Hemogram - WBC, RBC, hemoglobin, hem" . During the same period patient was treated with none. Patient recovered.

HPV (GARDASIL) Side Effects Report #341864
HPV (GARDASIL) vaccine side effect was reported on 03/13/2009. Female patient, child 11.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Fatigue, "Fatigue, joint pain after immunization until 3/08." None"Positive, ANA" . Patient recovered.

HPV (GARDASIL) Side Effects Report #342133
HPV (GARDASIL) vaccine side effect was reported on 03/13/2009. Female patient was vaccinated with HPV (GARDASIL). Patient symptoms: Fatigue, "Information has been received from a nurse concerning a female patient who on unspecified dates was vaccinated with the first and the second 0.5 mL doses of GARDASIL. ~Within a day~ after receiving the first and second dose of GARDASIL, the patient experienced fatigue for about a week and then the patient recovered. The patient sought unspecified medical attention. Additional information has been requested." UnknownUnknown . During the same period patient was treated with Unknown. Patient recovered.

HPV (GARDASIL) Side Effects Report #342147
HPV (GARDASIL) vaccine side effect was reported on 03/13/2009. Female patient, 22.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Fatigue, "Information has been received from a consumer concerning her 22 year old daughter, with no known drug reaction/allergies and no pertinent medical history, who on 26-AUG-2008, was vaccinated with the first of GARDASIL and on unspecified dates, was vaccinated with the second dose and third dose of GARDASIL. There was no concomitant medication. The reporter stated that her daughter started having side effects after getting the second dose of the GARDASIL vaccine. On 19-FEB-2009, the patient experienced nausea, rash at the injection site, abdominal pain, vomiting, muscle pain, weakness and complained of she felt sick all the time. The consumer stated that ~she did seek medical attention and they keep telling it is a stomach virus~. At the time of the report, the patient had not recovered. Additional information has been requested. 3/23/09 Received vaccine & PCP medical records of 12/4/08-2/24/2009. FINAL DX: none provided Records reveal patient experienced cold s/s of cough, fatigue, fever, nasal congestion, sore throat & wheezing on 12/4 & had sick family member. Dx w/acute nasopharyngitis & cerumen impaction. RTC 2/19/09 for routine GYN exam & HPV #2. RTC 2/20 w/colicky abdominal pain x 1 day. Exam revealed lower abdominal/pelvic pain thought to be premenstrual as due for depoprovera following wk. RTC 2/24 w/continued abdominal pain. No further records available. 3/23/09 Link w/342211." "None PMH: PUD, depo-provera contraception."None LABS: PAP smear WNL. . During the same period patient was treated with None. Patient recovered.

HPV (GARDASIL) Side Effects Report #342159
HPV (GARDASIL) vaccine side effect was reported on 03/13/2009. Female patient, 15.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Fatigue, "Information has been received from a nurse practitioner concerning a 15 year old female patient with endometriosis who on unspecified dates was vaccinated with the first two doses GARDASIL (lot number not specified). There was no concomitant medication. The patient experienced nausea, ~gagging~, flu-like symptoms and felt miserable 2 weeks after she received the second dose of GARDASIL. At the time of reporting, 2-Feb-2009, the patient had recovered. Additional information has been requested. 09/04/2009 Received vaccine & PCP medical records. FINAL DX: arthralgia; lymphadenopathy w/u benign; endometriosis; dyspepsia/gastritis. Records reveal patient experienced LLQ pain radiating into groin w/lymphadenopathy x approx 1 year; gagging in AM; heavy menstruation w/clots when seen 12/12/08. 12/16/08 Referred to Rheum when ANA was elevated;referred to surgeon to eval lymphadenopathy; referred for CT abd/pelvis to eval LLQ pain. Rheum consult of 8/20/09 reveals patient w/joint pain; abdominal pain & nausea x approx 2 yrs, worse at night & disturbs sleep; fatigue. Had been dx w/endometriosis & on BCPs which helped symptoms." Endometriosis"9/4/09 Medical records received w/PMH: Allergy: amoxicillin, biaxin. Family hx: MS, hypothyroid. HPV #3 given 7/1/09, LA, Lot # 0315Y""Medical records received w/LABS: EGD 12/08 (+) gastritis. ESR 9, ANA 1:80 speckled. RF neg." . During the same period patient was treated with None. Patient recovered.

HPV (GARDASIL) Side Effects Report #342449
HPV (GARDASIL) vaccine side effect was reported on 03/13/2009. Female patient was vaccinated with HPV (GARDASIL). Patient symptoms: Fatigue, "Information has been received from a physician concerning a female patient who on an unspecified date was vaccinated with a dose of GARDASIL (lot # not specified), intramuscularly. The patient experienced muscle pain, weakness and fatigue after receiving the GARDASIL vaccine. The physician indicated that the patient was planning report the events. The patient sought unspecified medical attention and underwent unspecified tests by a rheumatologist. At the time of reporting, the outcome of the event is unknown. Additional information has been requested." UnknownUnknown . During the same period patient was treated with Unknown. Patient recovered.

HPV (GARDASIL) Side Effects Report #342693
HPV (GARDASIL) vaccine side effect was reported on 03/13/2009. Female patient, 24.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Fatigue, "Information has been received from a nurse practitioner concerning a 24 year old female who on unspecified dates was vaccinated with the first and second doses of GARDASIL by IM. After receiving the vaccines, the patient experienced headache, fatigue and tiredness. The patient's symptoms resolved after sleeping for about 4 hours. Additional information has been requested." UnknownUnknown . During the same period patient was treated with Unknown. Patient recovered.

HPV (GARDASIL) Side Effects Report #341956
HPV (GARDASIL) vaccine side effect was reported on 03/16/2009. Female patient, 15.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Fatigue, "Fatigue, severe muscle aches all over body - sore muscles with touch. 3/20/09 Note received from PCP. Pt has not been seen at all since DOV. TC from parent 3/16/09 reporting fatigue, muscle aches-especially in arms since 3rd Gardasil in 12/2008. Will f/u PRN." NoneNone . During the same period patient was treated with Takes Claritin redi - tabs. Patient recovered.

HPV (GARDASIL) Side Effects Report #342131
HPV (GARDASIL) vaccine side effect was reported on 03/13/2009. Female patient, 20.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Fatigue, "Information has been received from a nurse practitioner concerning a 20 year old female with not drug reactions or allergies who on 20-FEB-2009 was vaccinated with a second dose of GARDASIL. Concomitant therapy included hormonal contraceptives (unspecified). On 21-FEB-2009 the patient experienced fatigue, nausea and dizziness. On 23-FEB-2009 the patient passed out while taking a shower. Subsequently, the patient recovered from these symptoms on 24-FEB-2009. She sought unspecified medical attention. Additional information has been requested." UnknownUnknown . During the same period patient was treated with hormonal contraceptives (unspecified); Merck Sharp & Dohme; lot number 660555/0279X; IM; dose unk.. Patient recovered.

HPV (GARDASIL) Side Effects Report #342378
HPV (GARDASIL) vaccine side effect was reported on 03/20/2009. Female patient, 15.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Fatigue, "Information has been received from a consumer concerning her 15 year old daughter with no past medical history and no drug reactions or allergies who in August 2008, was vaccinated with the first dose of GARDASIL. In October 2008, the patient received the second dose of GARDASIL. There was no concomitant medication. The consumer reported that the patient developed a low grade fever and felt ~sick~ the day after receiving her second dose of GARDASIL. During October and November of 2008, the patient experienced intermittent ~stomaches~, nausea and vomiting. Starting December of 2008 until the time of this report, she had experienced persistent extreme stomach pains and vomiting. The patient had been examined by three gastroenteriologists who were not able to determine the cause of her symptoms. She had missed 60 days of school. Lab diagnostics studies included a stomach empty test, CAT scan and blood tests with no results available. At time of this report, the patient had not recovered. The patient sought medical attention by an office visit. Upon internal review, low grade fever, felt ~sick~, intermittent ~stomaches~, nausea, vomiting and persistent extreme stomach pains were considered to be disabling. Additional information has been requested. 3//25/09 MR received from parent which include several GI consults and diagnostic testing. Per MR pt began having intermittent vomiting in Sept 2008. Usually at night waking pt, accompanied by abdominal pain, H/A and associated with shaking/shivering/chills. Occ nausea. 6-7 lb wt loss. ROS (+) for fatigue and chest pain. PE WNL except for eczematous rash on hip, iliac crest and axilla. Some improvement with Reglan but now c/o dizziness. W/U essentially (-). No final DX. 2nd GI consult seen 1/9/09. PE (+) for tenderness to palpation of the epigastrium, RUQ and RLQ. Has missed 28 school days since Sept 08. Labs and diagnostics: Upper GI WNL. CBC WNL. Chem WNL. H. pylori (-). BX of esphagus and stomach WNL. Some inflammation of lamina propria of duodenum. Uppe" None. PMH: none. NKDA"diagnostic laboratory, Stomach empty test - No results available; computed axial, No results available; diagnostic laboratory, Blood test - No results available. Labs and diagnostics: Upper GI WNL. CBC WNL. Chem WNL. H. pylori (-). BX of" . During the same period patient was treated with None. Patient recovered.

HPV (GARDASIL) Side Effects Report #342835
HPV (GARDASIL) vaccine side effect was reported on 03/23/2009. Female patient, child 12.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Fatigue, 1 wk. after pt. received vaccine she started c/o feeling tired. Pt had several weeks of fatigue symptoms that continued until Feb. 2008. Several different laboratory evaluations were performed and nothing could be related to pts. symptoms. Mom saw a television talk where another female child had similar problems. So mom wanted this reported. Mom is also a nurse and is concerned the vaccine may have been the reason for fatigue s/s for so long. NoneNoneNone . During the same period patient was treated with None. Patient recovered.

HPV (GARDASIL) Side Effects Report #342848
HPV (GARDASIL) vaccine side effect was reported on 03/27/2009. Female patient, 22.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Fatigue, "Headaches and Fatigue increasing in first 6 months after, leading up to dizzy and fainting spells, low blood pressure, and Migraines. Still experiencing the Headaches, Migraines, Fatigue, Hypotension, and Dizziness. 6/22/09 MR received from PCP including neuro consults from 10/24/08-3/29/09 with Dx: headache (784.0), R/O aneurysm, non-ruptured cerebral (437.3), Pharyngitis (462), Concussion NOS (850.9), Syncope (780.2), Lumbar radiculopathy (724.4), Scoliosis, ideopathic (737.3) and low back pain syndrome (724.2). Pt initially presented with c/o H/A s/p fainting episode with LOC and vomiting on 10/4/08. Dx as Vasovagal in ER. Since that time c/o H/A with occ vomiting. Using Benadryl to sleep. LMP 10/4/08. Neuro consults beginning 1/21/09 after 2nd episode 12/28/08. Pt felt sx coming on. Felt shaky and sat down. Vomited after. Episodes have been assoc with heartracing/palpitations/flutter. Reports difficulty reading. Neuro exam WNL. Assessment: Syncopal episodes w/o evidence of seizure. Seen 3/23/09 with c/o sore throat, h/a, lightheadedness, fatigue. Exposure to strep throat. PE (+) for tender anterior cervical nodes, pharyngeal erythema. Neuro f/u 3/23/09. Still reporting dizziness and daily h/a since initial event. Reports poor memory. To monitor BP at home. Heavy periods noted. MRI (+) for sinusitis." No"Allergic to Nuts, Latex,Cats and Seasonal Plants. PMH: Lyme, Mono, allergies to nuts, latex. Prone to fainting as child when exposed to blood. On OCs""EKG, MRI, Bloodwork, Urine Analysis. Labs and Diagnostics: Head CT (-). Cerebral MRA (-). MRI brain (+) for L maxillary sinusitis. EKG WNL. throat cx (-). Hct 33.4 (L). ALT 7 (L). Mono screen (-). EBV IgG Ab 2.86 (+), IgM (-). Lyme screen" . During the same period patient was treated with OrthoTriCyclin Lo. I have been on it since August 2005 and never experienced problems.. Patient recovered.

HPV (GARDASIL) Side Effects Report #342995
HPV (GARDASIL) vaccine side effect was reported on 03/30/2009. Female patient, child 12.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Fatigue, "swelling of injection site, low-grade temperature, muscle soreness, fatigue" NoneGardisal was the vaccine given on 3/27/09. It wasn't listed above . During the same period patient was treated with NONE. Patient recovered.

HPV (GARDASIL) Side Effects Report #342998
HPV (GARDASIL) vaccine side effect was reported on 03/30/2009. Female patient, 18.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Fatigue, "Clients mother call to Health Department on 03/30/09, received 1st HPV 07/29/08 at Health department, no adverse reactions after this vaccine. Received 2nd HPV 09/30/08 at other Health Department. Reports 1-2 weeks after 2nd dose, daughter experiencing ~blackout spells and severe headaches.~ Reports client had 1st seizure on 03/29/09. Has appointment with PCP this week. 4/2/09-records received for DOS 4/1/09-office visit after near syncope for past 6 months, usually can tell when they are coming on becomes lightheaded and roaring sensation in ears with occasional nausea. occurring about every other week. Headaches occurring weekly. Almost blakced out and had tremors muscles in arms and legs felt tight. Tired afterwards. Episodes began after gardasil vaccine and depoprovera, Assessment: near syncopal episodes. R/O possible seizure disorder. Episode of hyperventilation due to anxiety syndrome. 4/16/09-records received 4/1/09-C/O near syncope for past 6 months lightheaded and roaring sensation in ears and nauseated feeling with them. Headaches weekly. Tremors. Blackout spells and tired. Started depoprovera. Episode of hyperventilation due to anxiety syndrome. 4/8/09-office visit for blackout and near fainting episodes-Assessment:vasovagal event with convulsive syncope followed by hyperventilation syndrome. Prone to syncope and presyncope." UnknownUnknownUnknown 4/2/09-records received-Labs WNL. . During the same period patient was treated with Unknown. Patient recovered.

HPV (GARDASIL) Side Effects Report #343029
HPV (GARDASIL) vaccine side effect was reported on 03/30/2009. Female patient, 24.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Fatigue, "Information has been received from a nurse practitioner concerning a 25 year old female with no allergies who on 22-MAY-2007 was vaccinated IM with the first dose of GARDASIL (lot# 657621/0387U). In April 2008, eleven months later, the patient experienced seizure. A magnetic resonance imaging (MRI) was performed (result unknown). Subsequently, the patient recovered from seizure. On 22-OCT-2008 the patient received the second dose of GARDASIL (lot# 661530/0575X) IM 0.5mL. The patient sought medical attention at the practice. Upon internal review, seizure was considered to be an other important medical event. Additional information has been requested. 7/27/09 Medical records received DOS 10/22/08 to 12/17/08. Includes EEG report from 5/13/08 and MR Brain from 5/15/08. Assessment: HPV. Patient presents with fatigue, sores in mouth, vaginitis. Cervical dysplasia. Acid Reflux. Alcohol use. Seizure in Fall 08 - patient considers event related to shellfish. Desires STD testing. Would like to restart Gardasil series (had initial dose in 5/07 but did not return for 2nd or 3rd doses). Dose of Gardasil given on 10/22/08 visit." Unknown"Unknown. LABS and DIAGNOSTICS: PAP Smear - Negative for Intraepithelial Lesion or Malignancy. Gen probes for gonorrhea, chlamydia. HepBsag, Hep C, HSV, and RPR. HSV culture. EEG - Abnormal - significance uncertain. MRI Brain - Negative." . During the same period patient was treated with Unknown. Patient recovered.

HPV (GARDASIL) Side Effects Report #343137
HPV (GARDASIL) vaccine side effect was reported on 03/31/2009. Female patient, child 12.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Fatigue, "1. 2 lesions on labia - lidocaine jelly, ACYCLOVIR 200 mg/ 2tsp TID 5cc TID. 2. Fever 100.2. 3. Coughing for 3 days. 4. Colitis x 3+ days. 5. Pharyngitis. 6. Eyes sticky. 7. Pains in hands and feet. Nystatin suspension 1 tsp swish and swollen qid x 2 wks. 7. Pains in feet and fingers - arthralgias - referral. 8. Epitaxis. 9. Headaches. 10. Fatigue home from school 3-13 -> 3/23 then half days. 11. Decreased appetite. 12. Lungs diffuse scattered rhonchi - z pack rheumatologist. 5/21/09 Medical records received DOS 4/7/09. FINAL DIAGNOSIS: Post viral syndrome. Post vaccination: Small healing lesions in corners of mouth and buccal mucosa. Previous viral illness with conjunctivitis, oral and genital sores. low grade fevers, and, marked fatigue." none"CBC - CRP - mono - negative; H simplex; urine culture; strep for A; labia cx - negative 5/21/09 Medical records received DOS 4/7/09. LABS and DIAGNOSTICS: Urine culture - 10,000-25,000 organisms/mL mixed flora. CBC - Neut 72% (H) Lymph" . Patient recovered.

HPV (GARDASIL) Side Effects Report #343591
HPV (GARDASIL) vaccine side effect was reported on 04/06/2009. Female patient, 18.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Fatigue, "Unexplained sudden and severe hair loss resulting in many visits to dermatologists over the last year and a half. This has resulted in meds prescribed by two dermatologists without significant results. Our daughter has also experienced several episodes of mono-like symptoms resulting in visits to the campus doctor and local doctor with negative test results. She continues to be extremely fatigued even when well-rested and has unexplainable headaches. 4/8/09 PCP notes received. Pt seen 3/23/07 for OV with c/o planter's wart on foot, anxiety r/t school work and difficulty focusing, keratosis on arms and allergy sx. PE (+) for allergic facies, boggy nares with some throat drainage. Sent for derm consult and allergy meds prescribed. 1st HPV vax given. Seen again 7/6/07 with c/o URI with ear pain, cough and sore throat. Assess: Nasal Pharyngitis. Per TC with MD-not aware of any AE from vax. Has not been seen since 7/6/07 visit. 4/14/09 Derm consults received. Pt presented 6/19/08 with c/o warts: thumb and plantar, and 8 month hx of hair loss. Generalized hair thinning noted. Warts removed and shampoo rx. Returned 7/10/08 for wart and mole check. F/U 3/19/09 for warts, acne and hair loss from the scalp. PE (+) for circular patches of hair loss with moderate flaking and minimal erythema of the scalp." None"Hives when taking meds containing red dye. PMH: Planter's wart on foot, anxiety r/t school work and difficulty focusing, keratosis on arms and allergy sx. Mono-summer 2007""Continuous and ongoing lab/blood work to determine cause of fatigue, mono-like illnesses and extreme hair loss. Labs: CBC WNL. TSH 1.87 (N)" . During the same period patient was treated with "Clobex and luxiq foam for hair loss. If no results, the next step is cortisone shots into the scalp.". Patient recovered.

HPV (GARDASIL) Side Effects Report #343756
HPV (GARDASIL) vaccine side effect was reported on 04/08/2009. Female patient, 22.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Fatigue, "I had the HPV vaccine Gardisil on March 31, 2009. The next day I was feeling soar and tired, but did not think anything about it. By Friday evening (April 3) I was still feeling tired, my body was aching, in general I did not feel well. I also noticed that my lymph nodes in me neck and groin were very swollen and very painful. This continued throughout the weekend and did not get better. It became very painful to sit, stand and walk. Pain radiated through my pelvis, so I went to an urgent care clinic on Monday March 6th. There I went through a pelvic exam, palpation of my swollen glands, lab work and an ultrasound. I recieved a shot of rochephin and rocephin to take at home for 10 days, in case there was some kind of infection. I have had no fever. My sonogram was normal, other than showing my swollen glands. Labs are not back yet, but I believe they will be normal. However I still have painful swollen neck and groin glands. The groin glands are bothering me the most. 4/13/09-records received for DOS 9/6/08-C/O allergies. 4/6/09-C/O swollen glands and not feeling very good." No"Seasonal allergies, have been reciebing allergy shots weekly for 3 1/2 years, No allergies to yeast. I have never had a reaction to any vaccine before this one 4/13/09-records received-PMH:migraines.""Pelvic exam- noramal, palpation of swollen glands, labds including a cbc- results not back, pelvic sonogram- normal, other than swollen glands" . During the same period patient was treated with "I take lo estrin 24 daily, No other daily home medications, No other medications were taken that week, I do recieve allergy shots nut skipped the week of March 31, 2009". Patient recovered.

HPV (GARDASIL) Side Effects Report #343764
HPV (GARDASIL) vaccine side effect was reported on 04/08/2009. Female patient, child 12.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Fatigue, "At time and the months up to March there was no local or systemic reaction to any of the Immunizations given on 12/19/08. On March 3 patient came to the office with s/sx of fatigue, abd pain,and jaundice. UA done showed 3 plus Bilirubin and 2 plus Urobilirubin. She had hepatomegaly and splenomegaly and pharyngitis. Labs revealed Epstein Barr Positive IgG antibody which may indicate a past infection-mono. Patient returned to the clinic with severe jaundice, Negative Hepatitis panel with abnormal Hepatic levels. Was consulted with Pediatric Infectious Disease Specialist, repeat labs showed increases in liver enzymes and bilirubin level and US showed enlarged grossly thickened gallblader wall, mild hepatomegaly and mod splenomegaly. There was no evidence of bilary duct obstruction or pancreatic abnormality noted. Hospital consulted and patient was admitted where her hepatic levels continued to rise as well as her INR. She was at hospital for almost three weeks and a bone marrow was done. She was discharged 4/5/2009 and her hepatic functions and INR are continuing to be monitered. This form is filled out at the request of physicians in the event the vaccines contributed to the illness. We can send copies of hospital visit and labs if needed. Dr. is calling this ~seronegative hepatitis~. 4/16/09-records received-for DOS 3/17-4/5/09-DC DX:DC DX: Liver failure. Rash. Presented with sudden onset of emesis,l abdominal pain, diarrhea and jaundice 3 weeks prior to admission. Developed erthematous pruritic papular rash." NoNone knownMay fax if needed copies of labs and reports 4/16/09-records received-Transaminases elevated. Needle biospy showed acute hepatitis without necrosis. Hepatitis differential diagnosis is infectious versus autoimmune. Skin biopsy showed slig . During the same period patient was treated with none. Patient was hospitalized Patient recovered.

HPV (GARDASIL) Side Effects Report #343791
HPV (GARDASIL) vaccine side effect was reported on 04/06/2009. Female patient, 16.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Fatigue, "Patient is a 16-year-old female who presents today with mother. The patient states she was with her mom earlier getting her prom dress fitted when she blacked out. Her mom states her face when pale and her lips turned blue in color. The patient was out for about 2 minutes. She did not fall to the floor, because her mom was able to hold her up. The patient did stated that she had her knees locked while she was standing. She did say everything went black. When she woke up she did remember where she was at. She was very tired upon waking up and is still very lethargic. She did receive a GARDASIL shot in her right shoulder yesterday and meningitis shot in her left shoulder yesterday. Patient did have a similar episode back in November, the day after her first GARDASIL shot was given. The patient denies any vision changes, headache, nausea, chest pain, shortness of breath, bladder or bowel changes. She states she is still very tired and her legs feel very heavy. 4/10/09 ER record received for DOS 3/13-14/2009 with D/C DX: Syncopal event 2' to Gardasil. Depression. Pt presented after episode where pt had episode of pallor then LOC with lip cyanosis. Similar event after receiving 1st Gardasil vax. PE (+) for pallor and leg heaviness with difficulty lifting legs. Admitted for observation. D/C'd in am after ambulating." NoneNone. PMH: Febrile seizures. On OCsEKG-Normal limits. Labs and Diagnostics: Head CT WNL. CBC WNL. Chem WNL except CO2 low at 20.2. EKG WNL. . During the same period patient was treated with Unknown. Patient was hospitalized Patient recovered.

HPV (GARDASIL) Side Effects Report #343797
HPV (GARDASIL) vaccine side effect was reported on 04/02/2009. Female patient, 15.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Fatigue, "During the course on the vaccines, patient has developed debilitating abdominal pain. 4/15/09 MR received 5/5/08 to 4/13/09. 15 yr WCC 6/13/08 with normal exam. Recent US (+) for splenomegaly. HPV#1 given. HPV and MCV4 given 8/18/08. Retuned 9/2/08 with c/o ST, chest congestion. DX: LOM, pharyngitis, pneumonia. Returned 9/8/08 with fatigue, nausea and dry heaves. Wheezing on PE. DX: wheezing. improved with nebs. Returned 9/11/08 with stomach and back pain near rib cage. ? gas/constipation. Returned 10/7/08 with cold sx, chest pain/heaviness and hard to breath. DX: URI. Returned 11/19/08 with ST, neck swelling and fatigue. DX: Pharyngitis/Fatigue. ? Reactivated Mono. 11/21/08 LOM, Pharyngitis. Returned 12/10/08 with c/o stomach and back pain x 1 month. sharp pains near kidneys. PE (+) for abd tenderness. DX: Abd pain. Referred to GI. Seen 12/24/08. PE WNL. Impression: Chronic Abd Pain. Sent for tests. Back to PCP 1/29/09 with UTI. Returned 2/23/09 with c/o lower abd pain, severe x 4 days. Low grade temp. Pt reports missing a lot of school. Some constipation. Return to GI 2/25/09. PE (+) for tenderness to palpation of RLQ. DX: Recurrent abd pain. By 4/4/09 pt homebound. Continued sx." PMH: Mono-LLQ tenderness 5/5/08 with liver and spleen palpable at rib cage. Allergy to Biaxin"ULS, CT scan, blood work all normal. Labs and Diagnostics: KUB (+) (+) for scybala. UC (+) for 100K colonies. Colonoscopy WNL. Abd US (+) for borderline hepatomegaly. Splenomegaly resolved. Pelvic US WNL. CRP (-). Helicobacter (-). ESR 1" . Patient recovered.

HPV (GARDASIL) Side Effects Report #343867
HPV (GARDASIL) vaccine side effect was reported on 04/09/2009. Female patient, 17.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Fatigue, "Information has been received from a consumer concerning his 18 year old daughter with no pertinent medical history or no known drug allergies, who on approximately 29-AUG-2008 (reported as last week of August 2008) was vaccinated with the first dose of GARDASIL (Lot not reported). In December 2008 she received the second dose of GARDASIL (Lot not reported). There was no concomitant medication. On approximately 08-SEP-2008 (reported as the second week of September), the patient was diagnosed with aplastic anemia. She was having blood work every week and several other tests were performed. On an unspecified date, the patient stayed in the hospital for 10 days. As of 03-MAR-2009, the patient had not recovered from aplastic anemia. Additional information has been requested. 4/14/09 Received hospital medical records of 2/24-3/5/2009. FINAL DX: very severe aplastic anemia; profound pancytopenia Records reveal patient experienced progressive anemia & fever, HA, blurred vision, sore throat, epistaxis, gum bleeding, nausea, 1 episode of emesis x 1 mo. Developed petechiae & wet purpura, tachycardia, HA. Tx w/IV antibiotics, multiple blood & plt transfusion & immunosuppressive therapy. Gradually improved & d/c to home on oral antibiotics, continued immunosuppresants to be f/u in clinic 4/14/09 Received PCP medical records of 2/21-2/24/2009. FINAL DX: none provided Records reveal pt had been seen in urgent care 2/21 for sore throat, fever, nausea, vomiting, fatigue, malaise. Had been exposed to sick contacts at school. Dx w/pharyngitis & URI." "None PMH: asthma, pneumonia x 2 2006 & 2008, oral contraception.""hematology LABS: WBC 1.5(L), ANC 400, H/H 4.7/13.2, plts 3,000. Bone marrow biopsy. Strep & mono c/s neg. CXR WNL." . During the same period patient was treated with None. Patient was hospitalized Patient recovered.

HPV (GARDASIL) Side Effects Report #343922
HPV (GARDASIL) vaccine side effect was reported on 04/10/2009. Female patient, 18.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Fatigue, "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." none also received TB test/neg"PMH: Irregular menses. Juvenile osteoporosis. Heart murmur in childhood. Allergy: suprax. Family hx: CAD, asthma, DM, CVA, colon, cervical & breast cancer.""Tests done on 4-8-09, show high SED rate and low blood iron levels. LABS: H/H 9.7/29.0(L). ESR 30(H). CMP, TSH, T4, mono WNL. ANA (+). RF neg. Uric acid 3.7(N)." . Patient recovered.

HPV (GARDASIL) Side Effects Report #344001
HPV (GARDASIL) vaccine side effect was reported on 04/10/2009. Female patient, 24.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Fatigue, "Information has been received from a physician concerning a 24 year old female with allergies to tomatoes and pollen, migraine, rhinitis seasonal, deviated septum and band-aids and a history of GERD who was vaccinated with the first and the second dose of GARDASIL July 2007 and October 2008 respectively at her OB/GYN. Concomitant therapy included ADVIL and ORTHO TRI-CYCLEN. The patient developed some reactions a week or 2 after getting the 2nd dose of GARDASIL. The patient experienced swelling of the joints starting from the left knee and then moving to other areas. The patient had stiffness of her hands, angioedema of the lips and generalized urticaria. The joint conditions subsided somewhat and she still had minor stiffness. The welts were still ongoing and itchy. She treated herself with ADVIL as needed, used 1 dose of BENADRYL, and was given an unspecified NSAID. She was just given a new antihistamine, XYZAL on 24-MAR-2009. Around the same time of these events the patient was given an unspecified antibiotics when she had a wisdom tooth removed. Physician was investigating both serum sickness reactions. The patient was seen by a group of physicians throughout the time period of the symptoms. The patient's C reactive protein was slightly elevated. Other labs were pending: CBC panel, latex and food allergies, thyroid, etc. Follow-up information has been received from a consumer who a few days after receiving the second dose of GARDASIL started to experience swelling in her knee, fatigue, and a blister at the injection site. Then she started to develop swelling and pain in other joints which made it difficult to walk. The consumer reported that she saw her primary care physician a few times and thought it may be Lyme disease or lupus, but after a few months of this going on, the patient realized that she received GARDASIL. The patient then saw a rheumatologist in January 2009 and she had blood work done which showed she had elevated C reactive proteins. Around the time she saw the rheumatologist, the patient deve" Food allergy; Pollen allergy; Nasal septum deviation; Prophylaxis; Adhesive tape allergy; Migraine; Rhinitis seasonal"Gastrooesophageal reflux disease; Wisdom teeth removal. PMH: one episode of knee swelling and pain ~10/2008 which self resolved. OCs. PMH: wisdom teeth removal & tx w/antibiotic approx 2 wks prior to symptoms; seasonal allergic rhinitis; deviated septum; GERD; migraines; benign heart murmur; OCP Allergy: cockroach, dust mites & pollens, adhesive tape, insect stings. Family h""Serum C-reactive, 01/??/09, slightly elevated 5/26/09 Received rheumatology consult DOS 1/13/09. LABS and DIAGNOSTICS: C-Reactive Protein 2.1 mg/dL (H). Epstein-Barr VCA IGG AB 4.61 (H). Chest X-ray - No evidence of acute pulmonary dise" . During the same period patient was treated with Antimicrobial (unspecified); ORTHO TRI-CYCLEN; ADVIL. Patient recovered.

HPV (GARDASIL) Side Effects Report #344109
HPV (GARDASIL) vaccine side effect was reported on 04/14/2009. Female patient, 20.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Fatigue, "Nausea, fatigue for one week after vaccine administration. Seen in clinic on 04/14/09. Afebrile, WT 150#, BP 130/67. HEENT-negative, abdomen soft, non-tender, no masses. Patient current on depo provera." diarrheasulfa"TSH, CBC, BHCG, mono spot" . During the same period patient was treated with depo provera. Patient recovered.

HPV (GARDASIL) Side Effects Report #344155
HPV (GARDASIL) vaccine side effect was reported on 04/09/2009. Female patient was vaccinated with HPV (GARDASIL). Patient symptoms: Fatigue, "My daughter is 13 yrs old and has received the gardasil vaccine during which before receiving the 3rd vaccine I was notified that there would be some information broadcasted. I did decide not to give her the third vaccine due to her having some of the symptoms which included headaches, abdominal pain, nausea, fatigue, shortness of breath, chest pain or tightness, I have taken her to the emergency room twice this month for those symptoms and the physicians are not sure what is happening and say it could be asthma but I am concerned that it is more than that. Please let me know what else we need to do. Thank you." . Patient recovered.

HPV (GARDASIL) Side Effects Report #344157
HPV (GARDASIL) vaccine side effect was reported on 04/11/2009. Female patient, 18.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Fatigue, "After injection at 2:33 pm on the date above, Rainbow began to experience, dizziness, fever, sore throat, severe arm pain. Today, the next morning, she is weak, tired, and still has sore throat." . Patient recovered.

HPV (GARDASIL) Side Effects Report #344256
HPV (GARDASIL) vaccine side effect was reported on 04/15/2009. Female patient, 17.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Fatigue, "Information has been received from a consumer concerning her 17 year old daughter with no pertinent medical history and no known drug allergies/drug reactions who on 16-FEB-2009 was vaccinated with the first dose of GARDASIL. Concomitant therapy included meningococcal vaccine (manufacturer unknown). It was reported that ~2 hours after getting the vaccine~ the patient started having trouble breathing and feeling chest pains. The patient was taken to the emergency room but was not admitted overnight. ~A full work up was performed at the emergency room (results not provided), also a computed axial tomography scan, electroencephalography and magnetic resonance imaging were performed (results not provided). It was reported that she had couple more breathing episodes since. The patient also experienced seizure like activity starting on 11-MAR-2009. It was reported that the first seizure was pretty severe and the patient did not calm down until she was given ATIVAN. It was reported that the patient overall was experiencing tiredness, weakness, chest pains, dizziness and nausea. The patient was seen at the practice. It was reported that the patient had not recovered at the time of the report. Upon internal review, seizure-like activity was determined to be other important medical event. Additional information has been requested." UnknownUnknown . Patient recovered.

HPV (GARDASIL) Side Effects Report #344285
HPV (GARDASIL) vaccine side effect was reported on 04/16/2009. Female patient, 17.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Fatigue, "3 days post vaccination, patient had eruption of hives and developed extreme fatigue, arm and leg pain, and muscle weakness, severe enough that she had to discontinue participation in track. Symptoms are slowly resolving, but lower extremity weakness complaint persists. 4/24/09 MR received from PCP. OV 3/17/09 with c/o pruritic rash, fatigue and heaviness and aches in the legs. Sore throat last week. PE (+) for nasal mucosa and throat erythematous, increased anterior nodes, erythematous, hive-like lesions on the arms, legs and back. Assess: Urticaria. URI. Constipation. Office note 4/14/09 states pt still c/o leg heaviness, rib pain, stomach pain, muscle aches and fatigue. RTC 4/16/09 with c/o fatigue, extremity pain and weakness. Had to quit track 2' lower extremity weakness. PE (+) for 1+ patellar DTRs and able to get out of chair using arms. Assess: ? myalgias and lower extremity weakness 2' to Gardasil." N/A"History of thyroid nodule; Raynaud's syndrome. PMH: H/A. thyroid nodule with surgery. acne. Raynaud's. folliculitis. herpes zoster 8/07, abnormal brain MRI, ear tubes, arm fx, nasal fx./""CBC, CK-muscle, ESR, ANA pending Labs: WBC 4.2. CK 91 (WNL). ANA (-). (no ESR done)" . During the same period patient was treated with N/A. Patient recovered.

HPV (GARDASIL) Side Effects Report #344345
HPV (GARDASIL) vaccine side effect was reported on 04/17/2009. Female patient, 17.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Fatigue, "Initial fatigue, headaches, muscle cramps, muscle pain, sound sensitivityafter 1st shot. Increased in severity of all symptons. After 3 rd shot signficant increase in pain. Hip pain. Light,touch,smell sensitivity, chronic fatigue, tingling in hands, feet, sometimes all over body, faintness, joint spasmas. Poor, limited concentration. 5/27/09 Rheumatology records DOS 5/19/09. FINAL DIAGNOSIS: none provided. Post vaccination diffuse joint pain, lower back pain. Eye pain with photosensitivity. Recurrent urinary tract infections. Dysuria. Tenderness to lumbar spine. Decrease in lumbar flexibility. Tenderness at sacroiliac joints. Referral to ophthalmology and OB/GYN. 6/1/09 Rheumatology records DOS 2/18/09 to 5/27/09. FINAL DIAGNOSIS: Spondyloarthropathy with positive HLA-B27 and sacroiliitis, ankylosing spondylitis. Post vaccination developed low back pain, respiratory infection, pain left hip/buttock region. Decreased range of motion left hip. Hurts to walk. Pain has recurred in left knee and elbow. Fatigue. Mouth sores. Later presents with nausea, vision changes, photophobia. Urinary frequency. Muscle twitching and pain in some joints. Pain with stressing of sacroiliac joint. 4/20/09 Received PCP medical records of 5/22/07-11/02/2007. FINAL DX: none provided Records reveal patient experienced bronchitis when see 5/22/07. RTC 7/12/07 for HPV #1, lot # 0522U, IM/LA. RTC 9/26/07 for HPV #2 lot # 1060U, IM/RA. RTC 5/15/08 w/HA, fatigue, fever & sinus drainage. Dx w/sinusitis & tx w/antibiotic, nasal spray & antihistamine. 05/15/08 received HPV #3, lot 1757U IM/LA, and meningitis vax & Hep A vax (no lot #s provided for those). RTC 10/7/08 w/corneal abrasion right eye. Tx w/antibiotics. Ortho consult done 10/9/07 for right elbow pain x 10 mo s/p sledding accident 1/07 & dx w/sprain, probable ulnar collateral ligament tear. MRI revealed large tear of common flexor attachment at medial humeral epicondyle & referred for surgery. Tx w/injection & splinting but felt to need surgery later. No furthe" "Seasonal allergies, acne""acne, GERD, Allergic ceftin, dioxicillian. 6/1/09 Rheumatology records DOS 2/18/09 to 5/27/09. Heartburn, tennis elbow, knee pain, chronic fatigue. PMH: environmental allergies, obesity, hirsutism, acne, on BCP.""Positive sacroilitis 10-08.MRI 12-08 Diagnosed migrains, chronic fatigue, depression 4-09 5/27/09 Rheumatology records DOS 5/19/09. LABS and DIAGNOSTICS: MRI sacrum - sacroiliitis. Additional MRI of sacrum and X-ray lumbar spine - pendi" . During the same period patient was treated with "Mircette,multi vitamin, zantac. 6/1/09 Rheumatology records DOS 2/18/09 to 5/27/09. Zantac, tetracycline, Celebrex, birth control pills, fish oil, multivitamins, tramadol. Enbrel, Bactrim.". Patient recovered.

HPV (GARDASIL) Side Effects Report #344363
HPV (GARDASIL) vaccine side effect was reported on 04/17/2009. Female patient, 15.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Fatigue, "During summer of 2008, patient had many episodes of anxiety which she never had before, she also is more easily confused; 9/30/08 Dr visit for side pains, and sore neck, 2nd dose of gardasil given at this visit; 10/28/08 Dr visit for dizziness, headaches and stomach pain, Dr attributed to gas, and rec increase fluids, and tylenol; 11/11/08 Dr visit for muscle pain, near inability to walk, inability to raise arms, stomach pain, back pain, tingling, vibrating sensation of extremities, Dr rec continue Ibuprofen or aleve daily; symptoms slightly resolved for a short time; 3/26/09 Dr visit with another doctor in practice- gained 10 lbs in fluids, severe ankle swelling numbness and tingling of feet, had been having nightly fevers for 10 days prior, legs and arms go numb when ~crossed~ for a few seconds, these symptoms have gotten better for now, she does still have headaches, dizziness and lightheadedness. 5/4/09 Received PCP medical records of 10/19/07-3/26/2009. FINAL DX: polymyositis Records reveal patient experienced usual state of good health on 10/19/07 when received HPV & Menactra. RTC 2/9/08 w/sore throat x 2 days, fever x 1 day, nasal congestion & fatigue. Dx w/strep throat & tx w/IM antibiotics. RTC 4/18/08 w/fever & sore throat x 2 days. Dx w/laryngitis/croup. RTC 10/28/08 w/dizziness, HA, stomach pains, low grade fever, hoarseness & cough x 2-3 days. Dx viral laryngitis & URI. RTC 11/11 w/muscle pain & tingling x 2-3 wks. Dx w/myalgias & paresthesias. Referred to Neuro. RTC 1/14/09 w/resolved polymyositis. RTC 3/16/09 w/pharyngitis. RTC w/ bilateral ankle swelling, possible facial edema, malaise, tonsillitis. Labs done but were unrevealing." no"seasonal allergies PMH: chickenpox, seasonal allergic rhinitis, keratosis pilaris, mild scoliosis, anemia.""elevated liver enzymes, elevated wbc, decreased rbc, lowered hct, 16.8 rdw, lowered segs, raised lymphs, raised metas and aniso, elevated esr, ast was raised, alkaline phosphatase and ALT were severely raised; her blood pressure is also hig" . Patient recovered.

HPV (GARDASIL) Side Effects Report #345244
HPV (GARDASIL) vaccine side effect was reported on 04/14/2009. Female patient, 16.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Fatigue, "Information has been received from a Registered Nurse (R.N) concerning her 16 year old daughter with juvenile rheumatoid arthritis, and allergies to BACTRIM, ZITHROMAX, CECLOR, potatoes, tree nuts, peaches, pears and apples who in November 2008 was vaccinated with the first dose of GARDASIL. There was no concomitant medication. It was reported that the patient received the first dose of GARDASIL and has been sick for 6-8 weeks. It was reported that the patient was fatigued, nauseous, vomited, stomach hurt and lost 8 pounds. It was reported that the patient's stomach hurting was getting better but she was still fatigued and had not gain the 8 pounds of weight back that was lost. No significant disability was reported however the patient has seen three unspecified physicians and has missed school. A gastrointestinal work up, allergy work and blood work were performed (results not provided). It was reported that the patient saw the pediatrician on 10-MAR-2009. It was reported that the patient took one pill of an unspecified ~gastrointestinal medication~ that gave the patient a bad stomachache. It was reported that the ~gastrointestinal medication may have been PREVACID or gastrointestinal pills (MSD). Additional information has been requested." Sulfonamide allergy; Allergic reaction to antibiotics; Potato allergy; Allergy to nuts; Fruit allergy; Juvenile rheumatoid arthrUnknown . During the same period patient was treated with None. Patient recovered.

HPV (GARDASIL) Side Effects Report #345245
HPV (GARDASIL) vaccine side effect was reported on 04/14/2009. Female patient, 22.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Fatigue, "Information has been received from a consumer concerning her 22 year old niece who on approximately 24-FEB-2009 was vaccinated with a dose of GARDASIL (Lot # not reported) 0.5ml, intramuscularly. The patient took an at home pregnancy test a week after she got the vaccine and it was positive. In approximately February 2009, since the patient got the shot, she experienced swelling, tiredness, bloating and tenderness. At the time on the report the patient was not recovered. The patient did not seek medial attention. Additional information is not expected." Pregnancy NOS (LMP= unknown)"beta-human chorionic, was positive" . During the same period patient was treated with Unknown. Patient recovered.

HPV (GARDASIL) Side Effects Report #345277
HPV (GARDASIL) vaccine side effect was reported on 04/14/2009. Female patient, 15.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Fatigue, "Information has been received from a consumer concerning her 15 year old daughter with allergies to penicillin and other antibiotic and no pertinent medical history who in approximately 2008 (~about a year ago~), in fall 2008, and on 26-JAN-2009 was vaccinated with the first, second and third dose of GARDASIL respectively (lot # not provided). There was no concomitant medication. On approximately 26-JAN-2009 (~right after she received the third dose~) the patient experienced extreme fatigue, vomiting and headache that seemed to be getting worse everyday. Blood panel and CAT scan were performed (no results provided). At the time of reporting, the patient's extreme fatigue, vomiting and headache persisted. The patient sought medical attention via visiting primary care physician and pediatrician. Additional information has been requested. 5/13/09 medical records received DOS 1/26/09 to 3/31/09. FINAL DIAGNOSIS: Nausea and vomiting secondary to psychological issue. Post-vaccination feeling weak, tired, abdominal pain, fever, projectile vomiting, diarrhea. Bloody urine and cramps. Sore throat and swollen glands. Upper quandrant tenderness. Burning sensation in chest. Dizzeness, not eating well. Othostatic hypotension. Referred to counseling center. To schedule STD screening and pelvic exam." "Penicillin allergy; Allergic reaction to antibiotics 5/13/09 medical records received DOS 1/26/09 to 3/31/09. Tinea corporis,"5/13/09 medical records received DOS 1/26/09 to 3/31/09. Rape"Unknown 5/13/09 medical records received DOS 1/26/09 to 3/31/09. LABS and DIAGNOSTICS: CBC - MPV 7.1 fL (L) NE% 73.0 (H) BA% 1.4 (H) Lymph% 28 (L). EBV Antibody (-) CMV Antibody (-). CT Head WNL. Urine Culture no growth. UA - hazy, bili" . During the same period patient was treated with None. Patient recovered.

HPV (GARDASIL) Side Effects Report #345369
HPV (GARDASIL) vaccine side effect was reported on 04/14/2009. Female patient, 26.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Fatigue, "Information has been received from a medical assistant, for GARDASIL, a Pregnancy Registry product, concerning a 26 year old female with pain in shoulder and reflux and a history of abnormal PAP in June 2008 who was vaccinated with the first and second dose of GARDASIL on 29-JAN-2009 and 26-MAR-2009 respectively. Concomitant therapy included NAPROXEN and ranitidine. The patient was pregnant after the second dose of GARDASIL. After the patient was given the dose, the patient was given a pregnancy test because she was reporting symptoms of ~being tired and missed her monthly cycle~. The patient sought medical attention- spoke to her physician. Additional information has been requested." Pregnancy NOS (LMP= unknown); Shoulder pain; Gastroesophageal refluxPapanicolaou smear abnormal"beta-human chorionic, 3/26/09, pregnant" . During the same period patient was treated with NAPROXEN; ranitidine. Patient recovered.

HPV (GARDASIL) Side Effects Report #345373
HPV (GARDASIL) vaccine side effect was reported on 04/14/2009. Female patient, 25.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Fatigue, "Information has been received from a 25 year old female patient with penicillin allergy who on August 2008, was vaccinated with the first dose of GARDASIL (lot # not provided). In October 2008 the patient was vaccinated with the second dose of GARDASIL (lot # not provided). On February 2009 patient was vaccinated with the third dose of GARDASIL (lot # not provided). There was no concomitant medication. After the second and first dose the patient experienced fatigue and dizziness. Patient sought unspecified medical attention and had blood work done. Additional information has been requested." Penicillin allergyhematology . During the same period patient was treated with None. Patient recovered.

HPV (GARDASIL) Side Effects Report #345374
HPV (GARDASIL) vaccine side effect was reported on 04/14/2009. Female patient, 27.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Fatigue, Information has been received from a registered nurse concerning a 27 year old female patient with no pertinent medical history and no know drug allergies/reactions who on 19-JAN-2009 was vaccinated with the first 0.5 ml IM dose of GARDASIL (lot # 660616/0570X). There was no concomitant medication. On 20-JAN-2009 the patient experienced joint pain on her left arm where the vaccine was administered. The next day the pain spread to all joints along with fatigue. No lab diagnostics were performed. One week after the vaccination the patient recovered. The patient sought medical attention via seeing a physician. Additional information has been requested. NoneNone . During the same period patient was treated with None. Patient recovered.

HPV (GARDASIL) Side Effects Report #345376
HPV (GARDASIL) vaccine side effect was reported on 04/14/2009. Female patient, 19.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Fatigue, "Information has been received from a registered nurse concerning a 19 year old female patient with a history of mononucleosis at age of 15 who on 16-MAR-2009 was vaccinated with her first dose of GARDASIL (lot # unknown). The patient experienced soreness at the injection site the day the vaccine was administered on 16-MAR-2009. The patient was experiencing difficulty breathing, hear rate of 90-100, flushed face, weakness, fatigue, ~air hunger~ or claustrophobic feeling and severe headache on 25-MAR-2009 9 days after her vaccination. The patient had visited the physician's office for medial attention. The only medication the patient was on was ZOVIA (manufacturer unspecified) for the completion problems and painful menstrual cycles. The patient never had any heart rate problems or headache before. At the time of reporting the patient's difficulty breathing and heart rate of 9--100 and flushed face and weakness and fatigue and ~air hunger~ and claustrophobic feeling and soreness at the injection site and severe headache persisted. Additional information has been requested" Pain menstrualInfectious mononucleosisUnknown . During the same period patient was treated with ZOVIA. Patient recovered.

HPV (GARDASIL) Side Effects Report #345385
HPV (GARDASIL) vaccine side effect was reported on 04/14/2009. Female patient, 16.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Fatigue, "Information has been received from a physician assistant concerning a 16 year old female with penicillin allergy and sulfonamide allergy who on 05-JUN-2008 was vaccinated with a first dose of GARDASIL (lot number 659657/1487U). On 05-AUG-2008 the patient was vaccinated with a second dose of GARDASIL (lot number 659657/1487U) (injection site and route not reported). There was no concomitant medication. The patient developed a rash around her stomach lasting one week after the first vaccination. The rash came and went since the first vaccination. The patient also developed extreme fatigue, joint pain and was pale. The patient was tested positive for a variety of medical conditions. The patient had been tested for rheumatoid arthritis and mononucleosis but the results had not been received. The patient was prescribed prenatal vitamins, but she was not pregnant. The patient was seen in the physician's office. Laboratory test included pregnancy test, mononucleosis, AlC, blood cell count, MMA, thyroid and swallow study H. pylori Complete medical panel (results unspecified). The patient's mother refused the third dose due to the adverse events. At time of this report, the patient's events persisted. Follow-up information was received from the physician assistant concerning the 16 year old female. The Physician's assistant reported that it was determined on 27-MAR-2009 that the patient's mononucleosis and not the fact that she received two of three doses of GARDASIL resulted in the reported adverse events. Additional information is not expected." Penicillin allergy; Sulfonamide allergyInfectious mononucleosisUnknown . During the same period patient was treated with None. Patient recovered.

HPV (GARDASIL) Side Effects Report #344374
HPV (GARDASIL) vaccine side effect was reported on 04/18/2009. Female patient, 25.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Fatigue, "Extreme fatigue (20 hours of sleep for five days)Extreme body ache, confusion, dizziness 4/20/09 Received PCP medical records of 4/13/2009. FINAL DX: none provided Records reveal pt seen for HPV #2 & breakthrough bleeding on BCP. Reported no AE to HPV #1 other than pain at injection site. t/c to office on 4/17 to c/o fatigue, achy muscles & fever since 4/14. 4/29/09 Received additional PCP medical records of 1/30/08-1/16/2009. FINAL DX: none provided. Records reveal patient experienced lower abdominal pain & diarrhea 7/08. Colonoscopy done 8/22 abnormal w/congested mucosa left colon, redundant colon & internal hemorrhoids. Tx w/diet & meds. RTC 1/09 w/runny nose, achy, cough, fever & head congestion. Dx w/sinusitis & URI & tx w/antibiotics. RTC 5/08 w/weight gain, psych meds ineffective & pharyngitis." PMH: depression/anxiety.LABS: intestinal biopsy. CBC WNL. Lipid profile(H). Amylase/lipase WNL. US of abdomen WNL. . Patient recovered.

HPV (GARDASIL) Side Effects Report #344447
HPV (GARDASIL) vaccine side effect was reported on 04/20/2009. Female patient, 14.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Fatigue, "fever, vomiting,malise, headache could not get out of bed for 2 weeks after 1st shot. Developed periphreal neurapathy within 30 days of 1st shot. However it took 3 months to diagnose. Gastritis several times. Migraines constantly, fainting with muscle weakness...can not use legs for hours after faintinf, bloody stools, paralysis in right arm immediately after third vaccine. Pallor, clamminess, amennorhea no period since first vaccine. fatigue, insomnia, sleep apnea, chest pain, pins and needle sensations throughout extremities, sinusitis several times, pins and needles feelings in stomach, fevers on and off, slurred speech. She has been very ill since first vaccine and in a lot of pain. 5/1/09 Received vaccine & PCP medical records of 11/14/06-1/9/2009. FINAL DX: none provided Records reveal patient experienced shooting paine & numbness of extremities 2 wks prior to HPV #1 & flu shot. RTC w/recurrent depression, left plantar fasciitis, migraine HAs. Seen in ER 3/13/08 for HA & dx w/ethmoid sinusitis, tonsillitis & URI. RTC w/viral gastroenteritis, right CTS, recurrent allergic rhinitis. 8/18/08 w/spells x 3-4 yrs which had increased in frequency x 3 wks; dx w/presyncopal episodes. Seen in ER w/dx gastroenteritis. Referred to Neuro for syncope. Missed several days of school. RTC for LBP s/p fall, gastritis w/bloody stools. 6/15/09 Received consultant medical records of 1/29/08-5/26/2009. Pulmonology records reveal patient experienced sleep disturbance, obstructive sleep apnea, increasing obesity, nasal congestion, and allergic rhinitis. Residual cough. Low bloodpressure. ENT - intranasal mucosal edema and clear drainage, deviated septum, mouth and oral cavity small, enlarged tonsils, redundant pharyngeal mucosa, obese neck. Tonsillectomy / Adenoidectomy. Neurology - patient c/o burning in feet, dizzeness, fainting spells, clamminess, sweating, shooting pains in wrists /ankles, difficulty focusing / concentrating. Examination is unremarkable. Ophthalmologic evaluation reports some loss of peri" "hypoglycemia, PCOS, depression""mold, cockroaches, smoke, dust, dust mites, trees, grass,perfume allergies PCOS, blounts, hypoglycemia, PMH: exudative pharyngitis, metabolic syndrome w/hirsutism, Type II DM w/peripheral neuropathy, metromenorrhagia, morbid obesity, Blount's disease w/left tibial lengthenins & reshaping via cage, left gastrocnemius contracture, bronchitis, URI, sleep apnea, restless leg syndrom""EKG, Holter Monitor, EEG, Sleep Studies, Heavy Metal test, CBC, Urinalysis, Upper GI, Stool sample, Hepatitis test, CBC, metobolic study, Cat Scans, MRI, Has seen neurologist, pulmonary doctor, podiatrist, endocrinologist, tons on blood wor" . During the same period patient was treated with "lo-ogesterl, vitamins, metanx, glucophase, prozac, trazadone, spironlactone". Patient recovered.

HPV (GARDASIL) Side Effects Report #344555
HPV (GARDASIL) vaccine side effect was reported on 04/21/2009. Female patient was vaccinated with HPV (GARDASIL). Patient symptoms: Fatigue, "Given HPV injection approx. 8:20 a.m., Immediately felt sick and dizzy, thought she was going to vomit. There were two more incidents during day one; she said she felt more fatigued than usual and after waking up the second time after the vaccination had severe frontal head pain accompanied with dizziness. This is being reported on day two, patient says she continues to be dizzy and in general feels ill." No"Penicillin, no birth defects. Multiple ear infections, tubes in ears, Anxiety, encopresis, depression, seizures."This is the second day so there have not been any tests. . During the same period patient was treated with Seasonique (sp)? A birth control medicine. Patient recovered.

HPV (GARDASIL) Side Effects Report #344556
HPV (GARDASIL) vaccine side effect was reported on 04/21/2009. Female patient, 14.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Fatigue, "Previous diagnosis to vaccine-Hypothyroidism, Hashimotos,Acid Reflux, Anxiety, Depression, OCD and had occassional eye tics. Exacerbation of previous symtoms such as reslessness, restless legs, fatigue, weakness, eye and neck tics, anxiety, OCD and depression escalated after receiving vaccines. At time of 1st vaccine, pt was on Zoloft for 2 yrs, Synthroid and Nexium. After vaccines, different meds were prescribed by psychiatrist to treat pts symptoms. Beg Oct, it seemed as if everything got worse. Attendance in school affected beg Nov 07 she was barely attending in Dec 07 and officialy diagnosed with mild Tourettes. Everything was atributed to medication/akathasia, as any medical professional who was asked said ~no side effects~ with the vaccine, since she has a hx of anxiety, everything's assumed to be anxiety,so she was treated purely psychologically. The discomfort was unbearable for her leading to suicidal thoughts. Pt ended up in ER 2x, 1/22/08 admitted to adolescent inpt psych unit for almost 3 weeks, then partial hospitalization completed 4/11/08. After hospital-pt on 8 medications (6 psych). Never fully recovered, previous to vaccines, pt exercised daily for 2 hrs/day-still unable to exercise. Pt returned to school 9/08 with accommodations. Pt again experienced worsening of tics eye/neck and restlessness, muscle weakness and fatigue end of Feb 08. Attendance affected in school and unable to attend for 6 weeks beginning of March-home tutored. I believe that previous ailments were escalated by the vaccine. Still being treated for restlessness, muscle weakness, fatigue...gave #2 on 11-20-07 and #3 on 3-28-08. 5/13/09 Received hospital discharge summary DOS 1/22/08-2/8/08. FINAL DIAGNOSIS: Bipolar Affective Disorder, Generalized Anxiety Disorder, Tourette's Disorder Records reveal restlessness, aggression, suicidal ideation, self-injurious behaviors. Neurological tics. Hashimoto's thyroiditis, esophageal reflux. ICD9 codes: 296.30, 530.89, 244.9, 314.01, 307.23. 5/1/09 Received vaccine & PCP medica" no"Hypothyroidim, Acid Reflux, Hashimotos, Anxiety, Depression, OCD, eye tics Varicella(Merck) #2 Lot # 1182U given 10/26/07, LA; HPV #2, Lot # 1267U given 11/20/07, IM/LA; HPV #3, Lot #1978U given 3/28/08, IM/LA. 5/1/09 Received vaccine & PCP medical records of 11/07-1/09. Hypothyroidism, 23# weight loss, anxiety, depression, HAs, dizziness. Family hx: parent w/MS, tics, OCD.""Brain MRI, EEG-normal; bloodwork done 5/13/09 Received hospital discharge summary DOS 1/22/08-2/8/08. LABS & DIAGNOSTICS: Metabolic panel WNL. TSH WNL. Pregnancy(-). Prealbumin WNL. Hematology, CBC, urinalysis WNL. Blood Mercury WNL. EK" . During the same period patient was treated with "Synthroid, Zoloft, Nexium at time of vaccine". Patient was hospitalized Patient recovered.

HPV (GARDASIL) Side Effects Report #344584
HPV (GARDASIL) vaccine side effect was reported on 04/20/2009. Female patient, 14.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Fatigue, "Since 8/5/08, 2 wks after her 2nd GARDASIL shot, this girl has had severe back pain with diagnosis of Sacroileitis, pain Amplification syndrome. Pain 7/10, fatigued. Her best friend developed severity arthritis too after vaccine recently has missed 35 d of school 2008-9 5/19/09-records received-Office note 7/22/08 SI joint inflammed, positive for strep antibody. Right complex adnexal cyst. 9/25/08-bulging L4/5, C/O pain when walking. 4/2/09-back pain no relief. Orthopaedic evaluation 8/29/08-orthopaedic evaluation. C/O bilateral should pain began 1 week prior now low back pain and upper back pain. Migraine headaches in past. Impression: acute back pain of unlear etiology. Impression: thoracic back pain of unclear etiology. 9/5/08-worsening back pain, impression:thoracic pain with component of cervical pain. Rheumatology consult 10/2/08-impression:pain amplification." None"H/O ~Burning~ sensation of feet 5/19/08-records received-PMH:eczema. foot burning, foot pain in 2005 and 2006.""Negative HLA-B27; 9-11-08 Hg 12.5, Wbc5 100; Normal LFTS; U/A; IgG, A, ME, C3 C4; ANA; DNAA; RF ASO; Aule SSA & B; acute DNA SE, TY, TSH 5/19/09-records received-Laboratory tests normal. 9/3/08-x-rays demonstrate open growth plates of vert" . During the same period patient was treated with FOLIC ACID; METHOTREXATE; PREVACID; TRAUIADOL; ENBRIL. Patient recovered.

HPV (GARDASIL) Side Effects Report #344609
HPV (GARDASIL) vaccine side effect was reported on 04/21/2009. Female patient, 13.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Fatigue, "Initial and additional information has been received from a nurse practitioner concerning a 14 year old female who on 17-OCT-2006 was vaccinated with the first 0.5 ml dose of GARDASIL (lot #: 653735/0688) into the left shoulder. Concomitant therapy included ZYRTEC. In February 2007, the patient developed neck and right shoulder pain, later the patient was diagnosed with juvenile rheumatoid arthritis. The patient was seen by a rheumatologist. On 18-APR-2007, the patient's laboratory test revealed homogeneous antinuclear antibody (ANA) pattern 1 per 80. On 24-APR-2007, the patient's laboratory revealed rheumatoid factor 24.7 and C-reactive protein (CRP) 2.7. On 25-SEP-2007 the patient was seen by another rheumatologist. The patient also saw another physician and a homeopathic physician. On 21-APR-2008, the patient was seen by an orthopedist. On 09-APR-2009, the patient was seen by the physician in the reporter's office. The reporter stated that while the patient was waiting to see the physician, she was seated in a cross-legged position. It was reported the patient's mother request the patient to receive a whole body MRI. The physician was unable to examine the patient due to the patient's pain. The whole body was not ordered by the physician. The reporter stated that she thought the patient's mother was relating the patient's condition to the GARDASIL. Follow-up information was received from a medical assistant in a rheumatologist's office. The medical assistant stated that the patient was first seen the rheumatologist on 18-APR-2007. The patient's laboratory tests revealed a positive rheumatoid factor and a positive anti-CCP (anti-cyclic citrullinated peptide) test. The patient was diagnosed with juvenile rheumatoid arthritis. The medical assistant stated that there was no mention of the patient receiving the GARDASIL vaccine in the physician's notes. The patient was no longer a patient of the rheumatologist. Juvenile rheumatoid arthritis was considered to be disabling. Additional information has been requested." "Unknown. 6/19/09 Rheumatology consultant medical records received DOS 4/18/07 to 8/14/07. Acute brachial neuritis, URI, sinusitis, rash L hip. Fatigue and weakness. Stiffness, joint pain/swelling and muscle weakness/tenderness of R shoulder, neck, R knee, arms. Headaches, dizziness, muscle spasms and sensitivity or pain of hands and/or feet""serum ANA protein, 04/18/07, 1/80; serum rheumatoid factor, 04/24/07, 24.7; serum C-reactive, 04/24/07, 2.7; serum cyclic citrulline, 04/18/07, positive. 6/19/09 Rheumatology consultant medical records received DOS 4/18/07 to 8/14/07. LA" . During the same period patient was treated with ZYRTEC. Patient recovered.

HPV (GARDASIL) Side Effects Report #344919
HPV (GARDASIL) vaccine side effect was reported on 04/07/2009. Female patient, 16.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Fatigue, "Information has been received from a registered nurse concerning her 16 year old with no pertinent medical history and no drug reactions/allergies who on 29-DEC-2008 was vaccinated with the second dose of GARDASIL. No concomitant medications. On 29-DEC-2008, during the injection, the needle broke apart. It was reported that the patient only received part of the vaccine. On 20-MAR-2009 the patient has been a little tired and her arm was sore and she was having trouble lifting her arm. The patient sought unspecified medical attention. Additional information has been requested." NoneNone . During the same period patient was treated with None. Patient recovered.

HPV (GARDASIL) Side Effects Report #344767
HPV (GARDASIL) vaccine side effect was reported on 04/23/2009. Female patient, 15.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Fatigue, "Initial information has been received from a physician and follow up information has been received from a registered nurse concerning a 15 year old female with no medical history, who on 14-APR-2009 was vaccinated with a first dose of GARDASIL (lot # 661846/1312X). There was no concomitant medication. The patient had blood work drawn a few minutes after receiving the vaccination. After the blood work was drawn. The patient fainted for approximately 15 seconds and may have had a minor seizure. The patient's eyes rolled to the back of her head and she became unresponsive for about 15 seconds. It was reported that her pupils were dilated and she was out for about 15 seconds. The patient regained consciousness and was given juice to drink. No medications or treatment were given to the patient. The patient stated that she did not have much to drink prior to the physician's visit. The patient was not hospitalized. The patient was observed for a little while and then was sent home with her mother. It was reported that the patient stayed home from school the next day and reported she was tired and had some muscle aches. On 15-APR-2009 the patient's mother was instructed to call the physician back if the patient continued with any problems. The physician advised the patient not to receive the remaining doses of GARDASIL. The patient did not receive any other vaccinations other than GARDASIL on 14-APR-2009. The patient had an appointment to see the physician on 07-MAY-2009. Upon internal review seizure was determined to be an other important medical event. Additional information has been requested." None"diagnostic laboratory, 04/14/09, blood drawn" . During the same period patient was treated with None. Patient recovered.

HPV (GARDASIL) Side Effects Report #344793
HPV (GARDASIL) vaccine side effect was reported on 04/24/2009. Female patient, 14.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Fatigue, "Symptoms started exactly 2 months after her 2nd shot. Started with headaches, nausea, vomiting, strep throat and body aches. Continues on with non-epileptic seizures, twitches, unconsciousness, long and short term memory loss, hair loss, fatigue, joint pain and neck and back pain. Continues on after 3 1/2 months. 4/27/09 Received vaccine & PCP medical records of 8/1/08-2/3/2009. FINAL DX: encephalopathy w/memory loss. Records reveal patient experienced good general health on 8/1 when seen for sports physical. RTC 8/26 w/insect bite w/swelling, warmth & pain LUE, felt sick, nausea, HA. Tx w/antibiotics. RTC 12/18 w/vomiting, abd pain, nausea, chest pain x 1 mo, coughing, earache, migraine HA increased in frequency, sore throat, fatigue & malaise x 5 mo, excessive sleeping. Tonsils enlarged, strep test (+) & dx/tx for strep pharyngitis. RTC 1/5/09 appearing ill w/sore throat, cervical lymphadenopathy, sick stomach, nausea, vomiting, low grade fever, HA, decreased appetite, dizziness. Dx w/continued strep pharyngitis. Tx w/IM antibiotic & continued on oral antibiotics for another course. Seen in ER on 1/8/09. RTC 2/3/09 w/sore throat, sister w/strep throat. Parent reported episodes of seizure like posturing, gaze palsy, opisthotonos since 1/7/09 daily until 1/19. Had multiple ER visits. Hospitalized overnight for EEG which was WNL. No further seizure episodes but significant memory loss. Neuro-psych eval dx w/30% remaining memory. Missed a lot of school. Dx 2/3 w/pharyngitis, probably viral; encephalopathy w/memory loss, uncertain nature & cause. 5/18/09 Received hospital medical records of 1/16-1/17/2009. FINAL DX: nocturnal spasms Records reveal patient experienced muscle tension, arching back, eyes rolling back, unresponsive & dystonia nightly x 7-10 days lasting 15 min to 2 hr. School performance had been affected since mid-Dec when episodes had started. Admitted for 24-hr video EEG which was WNL. Neuro exam WNL. Referred to Psych. 5/20/09 ED records received multiple DOS 1/7/09" NoneNone PMH: Family hx: depression & manic-depression."blood work, head CT scan, lumbar CT scan, chest x-ray, head MRI, spinal tap 5/18/09 Received Hospital LABS of 1/16-17/2009: CO2 28(H) otherwise CMP WNL. PCP LABS: 6/3/08 & 12/18/08 throat c/s (+) strep. EBV neg. CBC, CMP WNL. Repea" . During the same period patient was treated with "None 5/20/09 ED records received multiple DOS 1/7/09 to 1/12. Phenergan, Ativan, Advil". Patient was hospitalized Patient recovered.

HPV (GARDASIL) Side Effects Report #344848
HPV (GARDASIL) vaccine side effect was reported on 04/20/2009. Female patient, 16.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Fatigue, "Received GARDASIL shot. Approx 3-5 min. later had several vials of blood drawn. After last vial pt. became ~rigid~, had muscle contractions, eyes were open, pupils were ~dilated~ and she mad some noises - per mother. Lasted 15-20 seconds. Examined by provider. Next day tired, but ~better~ per mother." . Patient recovered.

HPV (GARDASIL) Side Effects Report #344938
HPV (GARDASIL) vaccine side effect was reported on 04/27/2009. Female patient, 22.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Fatigue, "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" PMH: scoliosis. tonsillectomypositive anti nuclear antibody blood test. Labs: ANA 1:640. RF (-). Anti-DNA (-). Echo WNL. CXR WNL. US R LE (-) for DVT. . During the same period patient was treated with "pentoxifllyne,". Patient recovered.

HPV (GARDASIL) Side Effects Report #345018
HPV (GARDASIL) vaccine side effect was reported on 04/27/2009. Female patient, 20.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Fatigue, "Information has been received from a consumer concerning a her daughter 21 year old with penicillin allergy and no pertinent medical history who in June-2008 was vaccinated with first dose of GARDASIL (Lot # not provided) 0.5ml, intramuscularly. After the patient received first dose of vaccine she experienced nausea and recovered from rash. On 20-SEP-2008 the patient received second dose of GARDASIL (Lot # not provided) 0.5ml, intramuscularly. There was no concomitant medication. Then after the patient received second dose of GARDASIL she became nauseous again, developed a fever, and had headaches ~all the time~. It was reported that she no longer had the fever but she still felt nauseous and had headaches. She also ~had no energy~, ~no appetite~ and lost 25 pounds. She received NEXIUM and Omeprazole and ~each one worked for a day~ and then stopped working. She also received ZITHROMAX for her fever and she developed a rash after she stopped taking it. Blood test was performed to check her stomach and her gall bladder (results not reported). At the time on the report on 07-JAN-2009 the patient was recovering. The patient sought unspecified medical attention. Follow up information was received from doctor's office and medical record. It was reported that the patient had variable bleeding from 02-APR-2008 to 06-MAY-2008 and moderate bleeding 22-MAY-2008 to 17-JUN-2008. On 17-JUN-2008 the female patient with cyst and always bowel problem was vaccinated with a first dose of GARDASIL (Lot # 660393/0067X) 0.5ml, intramuscularly into left deltoid. She was having some menstrual irregularity at the time of her first vaccination. Since she had no bleeding when she was on DMPA. On 14-JUN-2008 her bleeding was very light. At that time she was prescribed FEMCON. The physician's impression was that the patient had abnormal uterine bleeding. On 19-AUG-2008 she was vaccinated with the second dose of GARDASIL lot # 660612/0229X into right deltoid IM. Approximately on 19?AUG-2009 the patient experienced nausea, anorexia, low grade" Penicillin allergy; Menstruation irregular; Cyst; Bowel discomfort; Diarrhoea; Constipation"6/8/09-records received for DOS 8/12/06 only. Seen in office after 2 panic attacks and ER visit. C/O tingling in fingers, tightening in chest, shortness of breath after an argument with boyfriend. Stree. PHM:chronic anxiety, chronic tension headaches and feeling unwell for past six month. 7/24/09 Medical records received DOS 5/9/08 to 4/16/09. Bowel problems. Oral Contraceptives.""Diagnostic laboratory, Blood test checked in her stomach and her gall bladder; Chest X-ray, 03/03/09, slight hyperinflation of lungs (see narrative); Hepatobiliary, 11/28/08, Gall bladder ejection was 44%; Diagnostic laboratory, 12/11/08, H" . Patient recovered.

HPV (GARDASIL) Side Effects Report #345307
HPV (GARDASIL) vaccine side effect was reported on 04/30/2009. Female patient, 17.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Fatigue, "Immediate severe pain in left arm, 'as though someone just broke it'; headache developed; 24 hours of joint and muscle pain; within weeks, sharp stabbing pain in the stomach that radiates throughout the upper abdomen and shoots toward the back and left shoulder; persistent upset 'sour' stomach that complicates her ability to eat. Now, 2 months later she is losing hair and weight. 5/4/09 Received PCP medical records of 1/5/08-4/30/2009 including GI, Ortho & ENT consults. FINAL DX: acid reflux, inflammatory gastropathy, ulcerative tonsillitis, exercise intolerance, dyspnea Records reveal patient experienced usual state of health on 2/23/09 for HPV#1. RTC 4/29/09 w/c/o of injection site pain, HA & joint pain since 2/23/09. Hx of persistent abdominal pain. GI referral 8/08. Dx w/pneumonia 12/08. RTC 1/09 w/exhaustion, sore throat, loose stool x 2 days. Exam revealed 4+ red exudative throat w/bilateral node tenderness. Strep & mono neg. RTC 2/09 w/chest tightness & difficulty breathing x 2 yr." had just recovered from the 12 hour stomach flu which she had on Feb 16th."Acid Reflux diagnosed in August, 2009; medication helped and all symptoms were gone by October. PMH: ADD, anxitey, exudative pharyngitis, ulcerative tonsillitis, epigastric pain, GERD, HA, fatigue, stiff neck, environmental allergies, vocal cord nodules, right shoulder AC strain.""Hyda Scan for suspected gall bladder issues, no problems noted; MRA is scheduled for May 13th for suspected MALS (Median Arcuate Ligament Syndrome); LABS: Upper endoscopy WNL. Gallbladder US neg. Biopsy WNL." . During the same period patient was treated with "Focalin, 10mg/day; aciphex, 10mg/day;". Patient recovered.

HPV (GARDASIL) Side Effects Report #345404
HPV (GARDASIL) vaccine side effect was reported on 05/01/2009. Female patient, 13.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Fatigue, "My daughter was given all three doses of Gardasil on 8/28/08, then on 11/1/08, and the last on 3/7/09. On April 11, 2009 my daughter suffered with two seizures on this day and was hospitalized for five days. There is no history of seizures in my family. She was then put on Keppra. A week and a half later she suffered with three more seizures. Patient was again hospitalized. Keppra was then increased to 1500 mg twice a day. Now we are going to the neurologist to try to pinpoint the cause. I did research and found the side affects of Gardasil and one of them were seizures. 6/17/09 Hospital ED records received DOS 4/23/09. Assessment: Seizure. Patient presents actively seizing with a history of having a tonic-clonic seizure. Sleepy, disoriented, lethargic (decreased awareness), responds to verbal stimuli, responsive to painful stimuli, postictal state, unable to speak. 7/14/09 Hospital records received 4/11/09 to 4/15/09 Assessment: New onset seizures. Patient presents with seizure for 3 hours. Suddenly became quite, uprolling of eyes, foaming from mouth, generalized 'tonicoclonic' seizure with 10-15 minute postictal phase. 3 episodes of vomiting. Headache. Morbid obesity. 7/14/09 Hospital records received 4/23/09 to 4/25/09 Assessment: Seizure disorder, breakthrough convulsion. Patient presents with Seizure (Tonic-Clonic) generalized for 5 minutes. Foaming at mouth, rolling of eyes. Three episodes. Post-ictal phase. Vomiting, feels tired. Hurt left side of head. Neurological follow-up suggested. ICD-9 Codes: 780.39, 278.00, 345.11 \ksk" NoneNone"Cat, MRI, EEG, Blood work 6/17/09 Hospital ED records received DOS 4/23/09. LABS and DIAGNOSTICS: EEG - Positive. MRI - Negative. CBC - HGB 12.4 g/dL (L). CHEM - Glucose 121 mg/dL (H) CO2 20 mmol/L (L). 7/14/09 Hospital records receive" . During the same period patient was treated with None. Patient was hospitalized Patient recovered.

HPV (GARDASIL) Side Effects Report #345696
HPV (GARDASIL) vaccine side effect was reported on 05/04/2009. Female patient, 22.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Fatigue, "Information has been received from a physician concerning a 22 year old female who on 23-APR-2009 was vaccinated with the second dose of GARDASIL. The patient received the first vaccination on 13-FEB-2009 (lot # reported as ~660825/0423X~). After receiving the second dose on 23-APR-2009 the patient's face turned white, eyes rolled back in her head and she had a seizure. The physician reported that after the patient had a seizure she was sent to her primary care physician for further evaluation. The physician reported that the patient's primary care physician wanted the patient to go and have test done but the patient wanted the patient to go and have test done but the patient refused. The physician reported that the patient was still feeling tired and she was under a lot of stress but she was recovering. Follow-up information was received from a physician. The physician stated that the patient had a seizure that lasted 4-5 min with tonic, clonic posturing. The physician stated that the patient was ~completely out~. The patient ~perked-up and came to with no postictal confusion~. The physician stated that the patient had no history of seizures. The seizure occurred immediately after the patient received GARDASIL. The physician stated that he was not sure if the patient had the seizure due to GARDASIL or a drop in blood pressure. The physician did not know if the seizure was due to a neurological disorder. The physician stated that he thought the patient's Primary Care was another physician. Upon internal review, seizure was determined to be an other important medical event. Additional information has been requested." UnknownUnknown . During the same period patient was treated with Unknown. Patient recovered.

HPV (GARDASIL) Side Effects Report #346052
HPV (GARDASIL) vaccine side effect was reported on 05/08/2009. Female patient, 13.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Fatigue, "Initial and follow-up information has been received from a consumer concerning a 13 year old female with no pertinent medical history and no drug reactions/allergies who on 13-MAR-2008, 23-MAY-2008 and 26-SEP-2008 was vaccinated with the first, second and third dose of GARDASIL respectively (lot # 659182/1757U, 660391/0063X and 659184/0843X), injection. Concomitant therapy included ibuprofen and AMITRIPTYLIN. In September 2008, the mother stated her daughter experienced chest pain, fever, nausea, muscle stiffness, headaches, stomach problem, and when she was not really feeling well in her pupils became ~dilated~, while on GARDASIL. She did not go to school and was not active because she could not even get out of bed. The patient had had chest X-rays, EEG'S, CAT Scans, sleep studies, and blood work done which all came back negative. The consumer also reported that the patient was an avid dancer before getting GARDASIL and she could not even get out of bed, ~I had taken her to specialist and other physicians and no one can figure out what is wrong~. The patient's outcome was not recovered. On unspecified date, the patient sought unspecified medical attention. The nurse stated that the patient's mother consented to come to the office to sign the Consent for the Release of Medical Information concerning the patient, and she would call back when the patient's mother signed the Consent Form about if the patient was able to attend school. Upon internal review she doesn't go to school and isn't active because she can't even get out of bed was considered to be disabling. This is one of several reports concerning the same source. A lot check has been initiated. Additional information has been requested. 5/18/09 Received vaccine & PCP office records of 2/20-3/23/2009. FINAL DX: fatigue syndrome Records reveal patient w/intermittent low grade fever, fatigue, HA, abd pain, chest pain since approx 9/08. No longer able to participate in dance & missed some days of school. Referred to Neuro, Cardio & ID. Seen in ER for p" "None 5/18/09 PCP med records HPV #1 given 3/13/08, Lot # 1757U, IM/RA; Hep A #1 given 3/13/08, Lot # AHAVB225BB, IM LA. HPV #2 given 5/23/08, Lot # 0063X, IM/LA. 6/1/09 Neurology consultation records received DOS 4/14/09. Otitis media, hearing loss, PE tubes, adenoids removed, cyst on neck. Hospitalized for dehydration. Rash. Learning disability. 7/17/09 Pediatric infectious""Unknown 5/18/09 PCP medical records LABS: CBC, CMP, TSH, T4, EBV, monospot, IgG all WNL. BE swallow, abd x-ray, KUB, CT head, MRI brain, EEG all WNL. 6/1/09 Neurology consultation records received DOS 4/14/09. LABS and DIAGNOSTICS: E" . During the same period patient was treated with "AMITRIPTYLIN mg; ibuprofen 6/1/09 Neurology consultation records received DOS 4/14/09. albuterol, amitriptylin.". Patient recovered.

HPV (GARDASIL) Side Effects Report #346230
HPV (GARDASIL) vaccine side effect was reported on 03/15/2009. Female patient, 22.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Fatigue, "At 1248am, I fainted, had possible seizure, unconscious for 1 hour, several months of testings, Dr's can't find what's wrong, since vaccine have several daily headaches, nausea, dizziness, difficulty thinking, depression, abdominal pains, extreme fatigue, no symptoms have improved. After faint, left arm and left leg became numb for approximately 5 hours. 5/14/09 Vax rec received from provider. HPV#1 7/3/07 0523U. HPV#2 7/15/08 1757U. HPV#3 11/17/08 0651X. Neuro consults date 11/19/08 and 12/17/o8 received with dx: syncopal episode, cervicalgia, headaches, mild anxiety, obesity. Pt presented for eval following syncopal episode (? vasovagal, cardiac or seizure) 2 days prior. Now with c/o H/A, numbness of the face, lips and neck-mostly on the L and dizziness. C/o ~fogginess~ on 12/17/08. 8/13/09 ER records received DOS 11/18/09. Assessment: Dizziness and Giddiness. Syncope and Collapse. Patient presents with anxiety and head trauma. States ~I woke up on the floor~. Does not remember falling on the floor. Last memory was going to bed. Bruise left cheek. Tenderness. Internal lacerations left side of mouth/lips. Hematoma. Headache." None"asthma; 2 herniated discs in lumbar spine L4, L5-S1. PMH: Asthma, disc herniations, concussion 4/2008. 8/13/09 ER records received DOS 11/18/09. PTSD. Herniated disks."Blood work; urine tests; CT scan; MRIs; echocardiogram; Stress test; EKG; EEG (electroencephalogram) Labs and Diagnostics: CT brain WNL. EEG WNL with intermittant theta wave surges. MRI brain. 8/13/09 ER records received DOS 11/18/09. L . During the same period patient was treated with None. Patient recovered.

HPV (GARDASIL) Side Effects Report #346249
HPV (GARDASIL) vaccine side effect was reported on 05/12/2009. Female patient, 13.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Fatigue, "Pt was home 1 1/2 hrs post vaccine & started to faint (Dad is a Dr. (cardiologist) and called it a ~near syncopal episode~ she also felt nauseous & tired. When she fell she fractured her rt pinky & bruised her right knee (taped up by orthopedist). Felt sluggish this am but went to school. * Also has menstrual period." NoneNone . During the same period patient was treated with None. Patient recovered.

HPV (GARDASIL) Side Effects Report #346485
HPV (GARDASIL) vaccine side effect was reported on 05/18/2009. Female patient, 25.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Fatigue, "extreme fatigue, migraines, nose bleeds, muscle & joint pain, sensitivity to light, mood swings, irritable, brain fog, dizzy spells, trembles, numbness, back pain, pins & needles, memory fog, skin rashes, pancreatitis, stomach ulcers, shortness of breath" nonenone"EEG's, CT scan, Utrasounds, GI problems," . Patient recovered.

HPV (GARDASIL) Side Effects Report #346500
HPV (GARDASIL) vaccine side effect was reported on 05/18/2009. Female patient, 15.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Fatigue, "Shortly after her first shot patient started having episods of what we thought were panic attacks. She had a hard time breathing, her heart would race and she could not catch her breath. After the second shot this so called panic attacks seemed to get worse and she was having them more freqently. She was tired all the time and a bit withdrawn. She had her third shot on June 9th of 2008 and on June 12th I saw one of these episods for the first time. I was stunned. This was no panic attack. She knows it going to happen she get a real intense pain on the top right side of her head. Usually within 30 to 60 seconds of the pain she becomes completly catatonic like. She is unable to comunicate at all. Then she goes into seizure like activity. But, during these seizures she goes into a breathing pattern, she will seizure like activity for about 45 seconds and then she will stop breathing for anywhere from 30 to 40 seconds and this will continue for anywhere from 2 mins to 50 mins. This has been going on for almost a year. She will have these episodes anywhere from 2 to 4 a week. 6/25/09 Hospital records and DC summary received DOS 6/4/09 to 6/9/09. Assessment: Paroxysmal disturbance, etiology indeterminate. Patient presents with stereotypical episodes consisting of sharp stabbing incapacitating discomfort in right parietal or temporal area. Hyperventilation, irregular breathing, unresponsive, dissociated, amnestic. Gardasil Dose #1 (0211U) LA 8/13/07 Gardasil Dose #2 (1266O) RA 1/21/08" nonenone. 6/25/09 Hospital records and DC summary received DOS 6/4/09 to 6/9/09. Migraine6/25/09 Hospital records and DC summary received DOS 6/4/09 to 6/9/09. LABS and DIAGNOSTICS: Total Protein 8.4 (H) Globulin 4.1 (H). Video EEG Monitoring - Normal. Pulmonary function test - Mildly increased residual volume otherwise WNL. . Patient recovered.

HPV (GARDASIL) Side Effects Report #346501
HPV (GARDASIL) vaccine side effect was reported on 05/18/2009. Female patient, 13.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Fatigue, "She has had dizziness, nausea and vomiting on and off since HPV was given 3/16/09, associated with body malaise. There was no reported fever. she had visited the ER 2x and had received IV hydration in 1 occasion. 7/3/09 ER records received DOS 5/15/09. Assessment: Gastritis - acute, no bleeding. Patient presents with vomiting, abdominal pain, dizziness, tired, lethargic, dizziness, facial pain. Dehydration. Posterior pharynx injected. Returned 5/28/08 with c/o sore throat, cough and fever. DX: Tonsillitis. T=102'F. Throat injected with exudate with swelling of R tonsil. D/C on amoxicillin. 7/8/09 PCP recs received. Pt in for OV 3/16/08 with cough, congestion, fever and sore throat. Dx with viral throat infection. HPV#1 given. On 4/6/08 parent reported that pt had experienced dizziness, nausea and vomiting since receiving the HPV vax. Been 2 ER twice. In for OV with c/o congestion, scratchy throat. itchy nose x 2 days. nasal turbinates and mucosa boggy with mucoid nasal drip. DX: Allergic rhinitis. Acute URI." "She had a sore throat no fever. rapid strep assay was negative and so was the throat culture. Pt in for OV 3/16/08 with cough,"7/3/09 ER records received DOS 5/15/09. Seasonal Allergies.7/3/09 ER records received DOS 5/15/09. LABS and DIAGNOSTICS: All labs normal. Throat cx (-) . Patient recovered.

HPV (GARDASIL) Side Effects Report #346780
HPV (GARDASIL) vaccine side effect was reported on 05/14/2009. Female patient, 16.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Fatigue, "Information has been received from a registered pharmacist concerning her 17 year old daughter with no pertinent medical history, who on an unspecified date was vaccinated with the third dose of GARDASIL. There was no concomitant medication. On an unknown date, the patient developed heart arrhythmia after getting the third dose of GARDASIL lot # was not provided. The patient sought unspecified medical attention. At the time of reporting, the patient had not recovered. Additional information has been requested. 7/10/09 Cardiology consult rec'd for DOS 5/12/08-6/5/09 with final dx: Wolff-Parkinson-White syndrome with supraventricular tachycardia. Pt initially presented 5//12/08 with ~ 1wk hx of episodes of palpitations which begin and end suddenly. Also reporting joint pain in the wrists, knees and ankles. Syncope with vomiting 7/2008. Episode of palpitations 5/26/09 at school and RN noted HR between 200-300. Sent to ER where the WPW dx was made. Cardiac ablation scheduled. 7/14/09 MR recd from PCP with vax info. Several OVs 4/2008-6/2008 r/t c/o fatigue and irregular heart rate. One episode ~2/2008. Referred to cardiologist (above). Dx: Fatigue, malaise, arthralgia, palpitation, irregular heartbeat, heart murmur..Seen 7/5/08 in f/u to sycopal episode on 7/4/08. Several month hx of fatigue, muscle aches, palpitations. Wearing a heart monitor which registered HR 32 during event. Dx: fainting. 7/15/09 ER record rec'd for 2 ER visits 6/7/08 and 5/26/09 as well as a heme/onc consult from 11/2008. Initially presented on 6/7/08 with c/o sudden onset of palpitations lasting~5 minutes. Resolved on arrival. .. To f/u with peds cardiology (above). Heme/onc consult 11/20/08 in f/u for von Willebrand. Reports sensation of heart racing and fatigue, but vW in good control. ER visit 5/26/09 with dx: Wolff Parkinson-White syndrome. SVT. EKG abnormal-see above." "Unknown PMH: Von Willebrand's Disease, OCs""Unknown . Labs and Diagnostics: EKG 5/26/09 abnormal (5/2008 WNL, 6/7/08 EKG borderline abnormal but may represent normal variant). Echo WNL. Holter 5/2008 WNL with several perceived episodes by pt." . During the same period patient was treated with None. Patient recovered.

HPV (GARDASIL) Side Effects Report #346786
HPV (GARDASIL) vaccine side effect was reported on 05/14/2009. Female patient was vaccinated with HPV (GARDASIL). Patient symptoms: Fatigue, "Information has been received from a consumer concerning her daughter, a female patient, who on an unspecified date was vaccinated with a dose of GARDASIL (lot number, site and route not reported). On an unspecified date, the patient experienced ~auto immune disease and fatigue~. The outcome of the event was not reported. No further information is available." UnknownUnknown . During the same period patient was treated with Unknown. Patient recovered.

HPV (GARDASIL) Side Effects Report #346895
HPV (GARDASIL) vaccine side effect was reported on 05/14/2009. Female patient, 24.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Fatigue, "Information has been received from a nurse practitioner concerning a 24 year old female with KEFLEX allergy and irregular heartbeat who on 30-MAR-2009 was intramuscularly vaccinated with the first 0.5 ml dose of GARDASIL (lot # 659182/1757U). On 06-APR-2009 the patient experienced facial flushing, intermittent nausea, intermittent headache and continued exhaustion. At the time of reporting, the patient did not recover. Follow-up information was received from the nurse practitioner who reported the patient had received the first dose of GARDASIL. The reporter stated that she had spoken with the patient over the phone on 21-APR-2009. The patient stated that she had fully recovered. Additional information has been requested." Allergic reaction to antibiotics; Heart rate irregularUnknown . During the same period patient was treated with Unknown. Patient recovered.

HPV (GARDASIL) Side Effects Report #346903
HPV (GARDASIL) vaccine side effect was reported on 05/14/2009. Female patient, 14.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Fatigue, "Information has been received from a Allergy Technician concerning a 14 year old female patient with no pertinent medical history and no drug reactions or allergies who on 14-NOV-2008 was vaccinated with a first dose of GARDASIL (Lot # 656049/0187U) 0.5ml, intramuscularly. Concomitant therapy included influenza virus vaccine (unspecified). On approximately 05-DEC-2008 the patient experienced fatigue and headaches. The patient was a basketball player and she could not participate in some recent drills. The patient had a schedule appointment to see a cardiologist on 06-MAY-2009. On 09-JAN-2009 the following diagnostics laboratory test were performed: Completed blood cell count (CBC), blood hemoglobin test (HGB): 11.7 was low, Lymphatic percentage: 47.2 was high and lymphatic number: 3.2 was high. At the time on the report on 17-APR-2009 the patient had not recovered. The patient sought medical attention was at office. Additional information has been requested." None"diagnostic laboratory, 01/09/09, 3.2, Lymphatic number. Was High; diagnostic laboratory, 01/09/09, 47.2%, Lymphatic percentage. Was High; hemoglobin, 01/09/09, 11.7, low; complete blood cell, 01/09/09, result not showed" . Patient recovered.

HPV (GARDASIL) Side Effects Report #346935
HPV (GARDASIL) vaccine side effect was reported on 05/14/2009. Female patient, 22.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Fatigue, "Information has been received from a licensed practical nurse concerning a 22 year old female with a medical history of knee operation in 2004 who on 09-OCT-2008 and 26-MAR-2009 were vaccinated with the first dose and second doses of GARDASIL (LOT# 659435/1265U and 661846/1312X respectively). Concomitant therapy included hormonal contraceptives (unspecified birth control pill). After the patient received the second dose, on approximately 08-APR-2009 the patient experienced dizziness, fatigue and general weakness. On an unspecified date the patient had workups done by her general practitioner and a neurologist, results were reported as negative. The patient was not hospitalized and was not recovered. Additional information has been requested." Knee operationUnknown . During the same period patient was treated with hormonal contraceptives. Patient recovered.

HPV (GARDASIL) Side Effects Report #346982
HPV (GARDASIL) vaccine side effect was reported on 05/14/2009. Female patient, 13.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Fatigue, "Information has been received from certified medical assistant concerning a 3 year old female patient with no drug reaction or allergies and no pertinent medical history who on 06-AUG-2007, was vaccinated with the first dose of GARDASIL (Lot # not provided) 0.5ml IM. On 16-OCT-2007, was vaccinated with the second dose of GARDASIL (Lot # not provided) 0.5ml IM. On 07-JAN-2008, was vaccinated with the third" NoneNone . During the same period patient was treated with None. Patient recovered.

HPV (GARDASIL) Side Effects Report #348105
HPV (GARDASIL) vaccine side effect was reported on 05/28/2009. Female patient, 22.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Fatigue, "Information has been received from a nurse practitioner concerning a 22 year old female with unspecified drug reactions/allergies and medical history who on 13-FEB-2009 was vaccinated IM with 0.5ml first dose of GARDASIL (lot number:661531/1311X) and second dose on 6-APR-2009 (Lot number 661952/1129X). Concomitant therapy included hormonal contraceptives (unspecified) and Adderall. Laboratory test were not performed. The nurse practitioner stated the patient received the second dose of the vaccine and experienced swollen glands on the left side of the neck. On 30-APR-2009, the patient went to see her primary care physician with neck pain and then a chiropractor. Subsequently on 6-MAY-2009, the patient came to see the nurse practitioner and she felt that intervention to prevent serious criteria was referring the patient to an ENT physician (Ears, nose, throat physician) to determine if a biopsy was needed. The outcome of the patient was not recovered and she sought medical attention by nurse and physician's office. Additional Information has been requested. 6/2/09 Medical records received DOS 2/13/09 to 5/27/09. FINAL DIAGNOSIS: Lymphadenopathy. Post vaccination reports feeling tired, sits with head turned to left, neck pain. Took several doses of Advil followed by nausea and vomiting. Headaches. Tenderness left lateral neck, palpable lymph node. Later several swollen glands. Chiropractic adjustments. Vaginal discharge. Vaginitis. Vaginal dryness." "None 6/2/09 Medical records received DOS 2/13/09 to 5/27/09. Migraine, bacterial vaginosis, asthma, ADD, appendectomy.""None. 6/2/09 Medical records received DOS 2/13/09 to 5/27/09. LABS and Diagnostics: Pending - CBC, monospot, HIV." . During the same period patient was treated with "Adderall tablets; Hormonal contraceptives. 6/2/09 Medical records received DOS 2/13/09 to 5/27/09. Imitrex, Advil, Keflex, Ortho Tri-Cyclen, Advair, Adderal". Patient recovered.

HPV (GARDASIL) Side Effects Report #348166
HPV (GARDASIL) vaccine side effect was reported on 05/30/2009. Female patient, child 12.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Fatigue, Fever - 102.7; Headache; Fatigue; Was given tylenol 480 mg every 4-6 hours for 16 hours; slept most of the day; drank liquids but did not eat; no other symptoms; headache only lasted a few hours; fever and fatigue lasted ~16 hours NoneNone . During the same period patient was treated with Multivitamin with Fluoride. Patient recovered.

HPV (GARDASIL) Side Effects Report #348291
HPV (GARDASIL) vaccine side effect was reported on 05/26/2009. Female patient, 13.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Fatigue, "Pt had unwitnessed seizure on 5/21/09. H/O probable seizure activity in the past 6 wks. After seizure, pt has had complaint of headache, dizziness, weakness, balance difficulty. 7/6/09 MR received for DOS 5/21-24/2009 with D/C DX: Seizure. Headache. Pt presented to ER after episode of unresponsiveness with limb flexion, staring, and fall. Disoriented with slurred speech, inappropriate affect, weakness, tiredness and severeH/A after. Recent episodes of involuntary fluttering of R hand. Started on Depakote." NoNear-syncope episodes. PMH: Allergy to Amoxicillin"EEG: 5/22/09, irregular diffuse spikes, polyspikes, generalized synchronized spikes suggestive of generalized seizure disorder. labs and Diagnostics: Head CT (-). EKG WNL. EEG abnornmal. MRI brain WNL." . Patient was hospitalized Patient recovered.

HPV (GARDASIL) Side Effects Report #348418
HPV (GARDASIL) vaccine side effect was reported on 05/29/2009. Female patient, 18.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Fatigue, "The date above is simply the most recent event, one of many throughout the past 9 months. This date reflects the diagnosis given by a neurologist of Parsonage Turner syndrome, a rare neurological syndrome which impairs her left arm and shoulder which she first noticed with chest, arm and shoulder pain in March. It has left her left arm and shoulder weak. Her left scapula is markedly bigger and different than her right. My daughter received her first GARDASIL shot in August, right before she left for college. Within two weeks she began having loose bowel movements, fatigue, and complaining of her ~legs feeling heavy~. She is a runner and was in excellent physical condition. By early October, she had her thyroid levels tested. Normal levels are between 0.5 and 4.5. Her level was 24 leaving extremely fatigued. By the time I got her home and seen by her own physician the levels had dropped dramatically and seemed to have remain now in the normal level. This ~acute thyroiditis~ is caused by a ~virus~. Shortly thereafter, she began have dizzy spells, nausea, near fainting spells, often but not exclusively concurring in the middle of the night while lying down heart racing and dysregulation of blood pressure. Along with nausea she had and continues to have burbing/acid reflux symptoms. She was hospitalized by a cardiologist and they found nothing wrong with her heart. They did try her on a bp regulation medication-FLORINET-which seem to make things worse not better. She was referred to and electro physiologist, who met with her but only recommended that she continue to monitor her bp. She had tingling in her face and arms, toothache, nausea - which she has-, migraine like headaches, and then most recently the diagnosis of Parsonage Turner syndrome. Most of these symptoms came and went...the dizzy spells lasted for about 3 months, the headaches have not occurred since April. The Nausea continues as does the tingling in her left hand and left arm weakness. Her stamina is not what it used to be. She tires easily. 7/27/0" Achilles tendinitis."My daughter was a healthy teen female with stable weight over her high school years. She was a runner who competitively raced and took remarkably good care of herself, ate well and exercised regularly. Her medical history was remarkable only for a history of strep throat and resulting tonsillectomy and adnoidectomy at age 10 and a knee injury from a bike accident after her sophomor""EKG; Echo cardiogram; Blood work; Chest x ray, done with nothing notable seen; Blood work for thyroid levels were done and were elevated but have since dropped and remained normal; Lyme's blood work was done and and results were negative. M" . During the same period patient was treated with "not known. 8/4/09 PCP medical records received DOS 8/20/08 to 10/25/08. Etodolac, multivitamin with iron. Fish oil. Synthroid.". Patient was hospitalized Patient recovered.

HPV (GARDASIL) Side Effects Report #348424
HPV (GARDASIL) vaccine side effect was reported on 06/02/2009. Female patient, 15.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Fatigue, "Nausea, vomiting, fatigue." NoneNoneNone . Patient recovered.

HPV (GARDASIL) Side Effects Report #348425
HPV (GARDASIL) vaccine side effect was reported on 05/20/2009. Female patient, 14.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Fatigue, "I took my daughter to a physician she had never been to before. While we were there the nurse suggested my daughter get the GARDASIL injection. I asked her 2 X's what are the side effects of this injection and she said only a slight chance of redness and swelling at the injection site. The Dr came in and AGA IN I asked her about ANY side effect of the GARDASIL, shot and she assured me that there was SIDE EFFECT. I said yes IF you ARE SURE there is NO CHANCE of any side effects.. 3 times I asked her BEFORE the injection. As soon as my daughter got the shot within SECONDS she felt sick. She became hot and clammy. At the check out desk at the Dr's, she felt very weak and dizzy..I asked the receptionists to call back and tell the Dr how my daughter was feeling, the Dr said it would pass. Within 10 minutes after the shot my daughter had extremely bad leg pain on the right side and could not walk. When we got home she felt very SAD and tired. During the night my daughter started throwing up. I called the ER and they said that that was not a normal reaction to an injection. That was Monday night, today is Wednesday and she still is having A LOT of symptoms and problems including muscle weakness, feeling sick, nauseous, chest pain, swollen glands, stomach pain. She went for blood work today and tomorrow a visit to the Dr who gave her the shot. This is CRAZY, she is suffering for what reason???? Because a Dr gave an injection WITHOUT either knowing- ignorantly-what can happen as a side effect on just not TELLING us. THIS MEDICATION SHOULD BE REMOVED..I my daughter should continue to suffer ANYTHING from this injection the makers will be SUED by US. 6/9/09 Medical records received DOS 5/18/09 to 5/20/09. Pt in for 14 yr WCC with 2-3 c/o coughing congestion. Vax given. Returned next day with c/o arm not feeling right since injections. Returned again 5/21/09 with c/o myalgias, abdominal pain and R-sided (illegible) pain and feeling ill since vax. PE . T=99.9. Assessment: Allergy. Myalgia. H/A. ? reaction to Gardasi" 6/9/09 Medical records received DOS 5/18/09 to 5/20/09. PMH: legally blind R eye."6/9/09 Medical records received DOS 5/18/09 to 5/20/09. LABS and DIAGNOSTICS: Urine - blood (+) CBC - Lymph 30.1% (L) ALT 28 U/L (L) Results Pending: C3, C4, Insulin Level. 6/22/09 Labs received: C3 131 (N), C4 30 (N), Insulin 3 (N)." . During the same period patient was treated with 6/9/09 Medical records received DOS 5/18/09 to 5/20/09. Tylenol. Patient recovered.

HPV (GARDASIL) Side Effects Report #348729
HPV (GARDASIL) vaccine side effect was reported on 06/08/2009. Female patient, 13.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Fatigue, "Information has been received from a physician concerning a 15 year old female patient who on 14-NOV-2006, 16-JAN-2007 and on 12-JUN-2007 was vaccinated with the first, second and third doses of GARDASIL (Lot # not reported). It was reported that in ~March 2009~ the patient experienced weakness, pain in her legs and hips and the patient sought medical attention with the physician, then she was admitted to the hospital for three days on 07-APR-2009. It was reported that the patient was diagnosed with ~acute demyelinating disease~. The physician noted that the patient received gamma globulin for three days. It was reported that the patient was recovering but not fully recovered. The reporting physician considered ~acute demyelinating disease~ to be disabling. The Health Care Professional contacted during telephone follow up could not supply the following information: patient name and Lot numbers. Additional information has been requested. The patient was hospitalized. 8/14/2009 MR rec'd from PCP which includes Neuro consult in f/u to hospitalization with DX: CIDP/sub-acute polyradiculopathy. Pt developed fever, cough, cold sx, abdominal pain, H/A and stuffy ears 2/9/2009. Flu (+). Dx: Viral Flu. Returned 3/5/09 with c/o hip pain, numbness/weakness in both feet, muscle stiffness. Had recent knee injury. Worsening by 4/2/09 and referred to neurologist. Admitted 4/23-29 with dx CIDP. Tx IVIG. Neuro f/u 5/22/09 with almost complete resolution of sx. 9/1/09 Hospital records received DOS 4/23/09 to 4/29/09 and 5/21/09 to 6/21/09. Assessment: Chronic Inflammatory Demyelinating Polyneuropathy (possibly secondary to influenza illness) Patient presents with bilateral upper and lower extremity weakness, influenza diagnosed 2/10/09. Fatigue, bilateral hip and calf pain. Range of motion decreased in lower extremiities. Reflexes absent. Wide-based stance. IVIG. Improved." "Unknown 8/14/2009 MR rec'd from PCP. Allergy to Ceclor and tree nuts. 9/1/09 Hospital records received DOS 4/23/09 to 4/29/09 and 5/21/09 to 6/21/09. Asthma, T/A, myringotomy bilateral."Unknown. 8/14/2009 MR rec'd from PCP. Labs and Diagnostics: EMG abnormal. CSF protein increased. 9/1/09 Hospital records received DOS 4/23/09 to 4/29/09 and 5/21/09 to 6/21/09. LABS and DIAGNOSTICS: CSF Culture - No Growth. CSF - Protei . During the same period patient was treated with Unknown. Patient was hospitalized Patient recovered.

HPV (GARDASIL) Side Effects Report #348764
HPV (GARDASIL) vaccine side effect was reported on 02/26/2009. Female patient, 14.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Fatigue, "Weakness, fatigue, rapid HR, abd pain, numb legs- sx's intermittent since then and continue. 7/2/09 Medical records received DOS 11/11/08 to 6/12/09. Assessment: PCOS (Polycystic Ovary Syndrome). Acute and chronic cervicitis, squamous metaplasia, inflammatory atypia with mild koilocytosis. UTI. Patient presents with abdominal pain, leg numbness, and cramping. Pelvic pain. Weakness, fatigue, rapid heart rate, short of breath, body numb. UTI. Feeling sick. 8/12/09 Received PCP medical records, no vax records. FINAL DX: conversion disorder Records reveal patient sexually active as well as having been sexually assaulted. Undergoing psych counseling & on depoprovera. Bouts of URI & tonsillitis as well as ongoing abdominal pain." NoneNone"7/2/09 Medical records received DOS 11/11/08 to 6/12/09. LABS and DIAGNOSTICS: Ultrasound abdomen - PCOS. Colposcopy - acute and chronic cervicitis, squamous metaplasia, inflammatory atypia with mild koilocytosis. PAP - Low grade squamous" . Patient recovered.

HPV (GARDASIL) Side Effects Report #348801
HPV (GARDASIL) vaccine side effect was reported on 06/09/2009. Female patient, 20.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Fatigue, "Beginning with 2nd gardasil vaccination, been having myriad of symptoms. Initial symptoms included headaches that started after the first vaccination and worsened after 2nd vaccination. Treated by family physician/P.A. for migraines on several occasions. After 3rd and final vaccination, symptoms included worsening headache, severe joint pain, muscle aches, intermittent low grade fever, malaise, severe fatigue, muscle weakness, etc. 6/26/09 Received ER medical records of 1/11/2009. FINAL DX: abdominal pain, PID; myalgias; Lyme disease. Records reveal patient experienced RLQ abdominal pain, nausea & anorexia x 1 day. Had started period that day. Temp in ER 99.3. D/c to home. Seen in ER again on 2/11/09. Had been dx w/Lyme disease wk prior & had pain in legs & arms, diffuse myalgias. Being tx w/oral antibiotics. Referred to Rheum." noneSeasonal allergies only 6/26/09 Received medical records PMH: OCP. orthopedic surgery.** Date indicated in date of vaccination is 3rd and final dose of gardasil vaccination when existing symptoms severely worsened. 6/26/09 Received medical records LABS: CT abd WNL. . During the same period patient was treated with "Ortho Tri-Cyclene Low, Midrin". Patient recovered.

HPV (GARDASIL) Side Effects Report #348807
HPV (GARDASIL) vaccine side effect was reported on 06/09/2009. Female patient, 17.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Fatigue, "Gardasil #1 (1423X) given in right arm on 4/23/09. Adverse reactions symptoms began 4/24/09 exhibited by: dizziness, headache, stomach pain, nausea, chest pains, shortness of breath, pins/needle sensations to feet, burning of skin, nerve pain to right elbow, fatigue, muscle weakness to legs, nausea, swollen lymph nodes to neck. Physician contacted 4/28/09 because this was felt to be in direct relation to the vaccine. She felt it was viral. 6/03/09 Same physician seen due to symptoms becoming more severe. Lab work drawn to rule out Mono due to swollen lymph nodes. 6/08/09 Pediatric Neurologist seen who confirmed that the symptoms were directly related to the Gardasil injection. Diagnosed peripheral neuropathy. 6/17/09 Medical and immunization records received DOS 4/23/09 to 6/3/09. Assessment: Pain & tingling, fatigue, lymphadenopathy. Patient presented with fatigue, headache, dizzy, chest pain, tingly feeling in arms and legs, pale, tender cervical lymph nodes. Referral to neurologist. LABS and DIAGNOSTICS: Planned CBC, ESR, CRP, Electrolytes, EBV, IgG, IgM. 8/3/09 Consultant medical records received DOS 12/12/08 to 6/29/09. Assessment: New onset symptoms after Gardasil. Patient presents with dizziness and waves of nausea. Chest pain, shortness of breath, and intermittent bifrontal headaches. Tingling of feet and hands with associated pain. Burning sensation in hands and quadraceps muscles. Off balance. Back pain. EB Virus pending. Neuropathic type pain - ulnar region. Allodynic pain. Tender in C2 to C6. Heart rate 74 and standing heart rate 100. Flat affect and dysphoric mood." Healthy"OCD. 6/17/09 Medical and immunization records received DOS 4/23/09 to 6/3/09. OCD, depression, anxiety, suicide attempts. Kidney stones. Weakness, dizziness. Allergy - Lamictal. 8/3/09 Consultant medical records received DOS 12/12/08 to 6/29/09. Tremor with intention, obsessive-compulsive dysfunction, mood disturbance. Allergy to Lacmictal. Kidney stone. Flexion of torso occuring m""CBC with diff/ plt, C-reactive protein, SED rate, electrolyte panel, Epstein Barr AB panel 6/17/09 Medical and immunization records received DOS 4/23/09 to 6/3/09. LABS and DIAGNOSTICS: Planned CBC, ESR, CRP, Electrolytes, EBV, IgG, IgM." . During the same period patient was treated with Lexapro. Patient recovered.

HPV (GARDASIL) Side Effects Report #349128
HPV (GARDASIL) vaccine side effect was reported on 06/15/2009. Female patient, child 11.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Fatigue, "5/27/09 S.T. Congestion; 6/2/09 Fever, leg pain; 6/6/09 headache, vomiting; 6/10/09 - broad-based gait, facial weakness/? asymmetry. 7/21/09 Hospital records received 6/11/09 to 6/23/09. Assessment Post-viral cerebellar ataxia. Patient developed pharyngitis, fever, sinusitis. Severe headache, vomiting, fatigue, malaise. Evaluated at several other clinics, given antibiotics and IV fluids. Subsequently lost appetite, developed right facial swelling, difficulty eating, jaw pain, slurred speech, and a wide stance gait. Presented to the ER with ataxia, fatigue and malaise. Fever, throat pain, jaw pain, URI, vomiting, back and lower extremity pain and lethargy. Ill in appearance. Difficulty opening mouth. Difficulty swallowing. Wide based gait, difficulty tandem walking. Nosebleeds. Miller Fisher Syndrome? ICD-9 Codes: 781.3 357.0 112.0 578.0 783.0 787.20 461.0 477.9 784.7" None7/21/09 Hospital records received 6/11/09 to 6/23/09. Allergic rhinitis. Augmentin causes vomiting."elevated CSF protein; Head CT and MRI normal. 7/21/09 Hospital records received 6/11/09 to 6/23/09. LABS and DIAGNOSTICS: CT Scan Head - no focal abnormalities. CSF - Protein 93 MG/DL (H), WBC 4 (H), NEUT 7% (H) LYMPH 85% (H) MONO 8% (L)." . Patient was hospitalized Patient recovered.

HPV (GARDASIL) Side Effects Report #349170
HPV (GARDASIL) vaccine side effect was reported on 06/12/2009. Female patient, 20.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Fatigue, "Information has been received from a 20 year old female patient with parakeratotic cells evidenced in previous PAP test, who on 20-APR-2009 was vaccinated with the first dose of GARDASIL. On 29-APR-2009 the patient vomited after receiving the vaccine. The patient further stated that she was still feeling weak, tired and dizzy. The patient did not seek medical attention. It was reported that GARDASIL was discontinued. At the time of reporting the patient had not recovered. No further information is available. 7/13/09 Medical notes received DOS 4/28/09 to 6/30/09. Patient presented on day of immunization for follow-up of abnormal PAP. Abdomen tender on palpation. Subsequent visits:pelvic pain, irregular 'bleeds' with thick white discharge, burning urine. Vaginal infection, UTI." Parakeratosis 7/13/09 Medical notes received DOS 4/28/09 to 6/30/09. Abnormal PAP.Unknown. . During the same period patient was treated with Unknown. Patient recovered.

HPV (GARDASIL) Side Effects Report #349193
HPV (GARDASIL) vaccine side effect was reported on 06/12/2009. Female patient, 15.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Fatigue, "Information has been received from a registered nurse (RN) concerning a 17 year old female who on 24-JUL-2008 was vaccinated with the first dose (lot number: 660553/0070X) and on 16-DEC-2008 with the second dose (lot number:661703/0651X) of GARDASIL (route not reported). On 16-DEC-2008, the patient appeared at the doctor's office and complained of flu-like symptoms (dizziness, nausea and hot flashes) which started approximately 09-DEC-2008 (one week prior to the office visit). The patient received the second dose despite the symptoms. The physician performed a physical diagnosed fatigue and dizziness and sent the patient for blood work (not specified) the same day. The blood work results were all normal. Additional information is not expected." Dizziness; Fatigue; Influenza like illnessUnknown"Diagnostic laboratory, 12/16/08, Blood work results normal; Physical examination, 12/16/08, diagnosed fatigue and dizziness" . During the same period patient was treated with None. Patient recovered.

HPV (GARDASIL) Side Effects Report #349295
HPV (GARDASIL) vaccine side effect was reported on 07/16/2009. Female patient, 18.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Fatigue, "Information has been received from a physician concerning a female patient about 20 years old who on an unspecified date was vaccinated with a dose of GARDASIL. It was reported that 2 months after GARDASIL the patient developed fatigue and generalized adenopathy. The patient consulted with the physician. It was reported that the patient had not recovered at the time of the report. Additional information has been requested. This is in follow-up to report (s) previously submitted on 6/12/2009; 6/18/2009; 6/30/2009. Information has been received from a physician concerning a female patient about 20 years old who on an unspecified date was vaccinated with a dose of GARDASIL. It was reported that 2 months after GARDASIL the patient developed fatigue and generalized adenopathy. The patient consulted with the physician. It was reported that the patient had not recovered at the time of the report. Information has been received from a physician via medical record concerning an 19 year old white student patient with allergy to apricots, cherries and almonds, a non smoker, rare alcohol user, she was sexually active and did have safe sexual practices, she was an immune competent patient, right handed and history of migraines, eczemn and cat scratch disease who on 15-AUG-2008 and in November 2008 was vaccinated with the first and second dose of GARDASIL. Other medications included ZYRTEC for which had been on for 8 years and birth control pills (unspecified) over the last year. The patient was evaluated for ongoing fatigue and intermittent adenopathy. It was reported that in September had developed a sore throat and question if the diagnosis had been a strep throat. She had been ill for about two weeks with arthralgias and myalgias. Just feeling poorly and subsequently after that developed bilateral rib pain that she felt was at the level of the ribs themselves. It was reported that she had not been doing any excessive coughing, but just had ongoing pain. At that particular time, did not receive any antibiotic th" Fruit allergy; Non-smoker; Alcohol use; Sexually activeMigraine; Eczema; Cat scratch diseasebody temp 101 degrees F - ; serum antistreptolyein - positive . During the same period patient was treated with ZYTREC; hormonal contraceptives. Patient recovered.

HPV (GARDASIL) Side Effects Report #349301
HPV (GARDASIL) vaccine side effect was reported on 06/12/2009. Female patient, 16.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Fatigue, "Information has been received from a consumer concerning her 16 year old daughter with lactose intolerance and not other drug reactions or allergies who was vaccinated with the first two doses of GARDASIL ~sometime in 2007~. After both doses she did not feel well. On approximately 22-APR-2009, ~three weeks ago~, the patient was vaccinated with the third dose of GARDASIL. There was no concomitant medication. On the night of 09-MAY-2009 the patient started to have a headache and stomach aches. In the past three days her stomach issues and headache have gotten worse, that she came home crying on 12-MAY-2009 because of the pain. As of 13-MAY-2009, ~today~, the patient was still experienced these symptoms and now she also felt hot to touch but did not have a fever. It was also reported that the patient just got her menstrual cycle and was going on three days of having that . No lab tests were done. The physician was called and unspecified medical attention was sought. The reporter was not sure the experiences the patient was having was from GARDASIL. Additional information has been requested.Records received 7/2/09-on 5/9/09 C/O headache, feeling feverish, stomach ache, tiredness, office note for 5/22/09-seen for C/O sinusitis no further visits." Lactose intoleranceNone . During the same period patient was treated with None. Patient recovered.

HPV (GARDASIL) Side Effects Report #349324
HPV (GARDASIL) vaccine side effect was reported on 06/12/2009. Female patient, 19.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Fatigue, "Information has been received from a physician concerning a female who was born on 09-Jun-1988 was vaccinated the first dose of GARDASIL (Merck) (LOT # 0210U), 0.5ml, on 23-MAY-2007. On 07-AUG-2007 she got the second dose of GARDASIL (LOT # 655620/0171U). There were no concomitant medications. Subsequently the patient experienced lymphomatoid papulosis after getting the first dose and second dose of GARDASIL. After that the patient sought medical attention. The patient never received the third dose. At the time of the report, the outcome was unknown. A medical assistant reported the patient's mother advised that the patient was undergoing treatment (no further information given) and would not be receiving the third dose. Additional information has been requested. 6/25/09 Medical records received DOS 12/28/07 to 12/24/08. Assessment: Lymphoid papulosis and iron deficiency. Patient presented with hives on upper extremities. Acne on face. Cellulitis L thigh, lymphadenopathy in groin. Lymphoid papulosis lesions on face, eyelid, legs buttocks. Shotty adenopathy neck. Infection R thigh. Oral contraceptives. Vaccine record: HPV-1 Merck 0210U RA 22.Nov.09 6/29/09 Medical records received 12/28/07 to 12/24/08. Additional information abstracted: Patient presented to oncology center with sweats at night, weight loss, rash and itching. Multiple open weeping papules yellowish in nature, others erythematous and reddish/brown, some are papulopustular. Present on eyelids, neck, arms, back, and posterior portion of legs. 8/24/09 Dermatology consult received. FINAL DX: lymphomatoid papulosis, type C, leaving scars. Records reveal patient experienced widespread & painful nodular lesions, ulcer on left hand, intermittent mouth sores, fatigue, nausea. Tx w/methotrexate starting 6/08, clobetasol propionate cream & folic acid. Developed MTX-induced pneumonitis. MTX d/c'd. Punch biopsy done when developed scaly patches c/w eczematous dermatitis. Tx w/PUVA & Oxsoralen starting 12/08 w/good results." None. 6/25/09 Medical records received DOS 12/28/09 to 12/24/08. Surgery for wrist fracture.None. 6/25/09 Medical records received DOS 12/28/09 to 12/24/08. LABS and DIAGNOSTICS: Chest X-ray negative for lymphoma. PET CT scan negative for lymphoma. Blood work normal. Bone marrow - low ferritin. . During the same period patient was treated with None. Patient recovered.

HPV (GARDASIL) Side Effects Report #349234
HPV (GARDASIL) vaccine side effect was reported on 06/09/2009. Female patient, 14.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Fatigue, Fatigue X 2 days NoneNone . During the same period patient was treated with None. Patient recovered.

HPV (GARDASIL) Side Effects Report #349269
HPV (GARDASIL) vaccine side effect was reported on 06/16/2009. Female patient, 18.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Fatigue, "1 month following 1st gardasil injection patient reports muscle weakness or pain, non-progressing. Also c/o fatigue. Medical records received DOS 5/27/09 to 6/16/09. Assessment: Acne vulgaris, fatigue, multiple joint arthralgia, acute bronchitis, acute pharyngitis. Patient presents with acne, generalized fatigue, muscle cramping all over, pain multiple joints, oral contraceptives. ICD-9 Codes: 706.1, 780.7, 719.49, 466.0. 462, V72.3" Allergic rhinitis only.NKDA. Chickenpox. Medical records received DOS 5/27/09 to 6/16/09. Second dose Gardasil given 5/27/09 (Lot# 0100Y) no worsening of symptoms."cbc, cmp, esr, arthritis panel all normal. Medical records received DOS 5/27/09 to 6/16/09. LABS and DIAGNOSTICS: WBC - Normal, HCT 36.2% CMP WNL, ESR 4, ANA (-), RF (-), ASOT 82. EBV IgG (+) IgM (-). Toxo (-). CMV (-) Cocci (-)." . During the same period patient was treated with "allegra D, veramyst. Oral contraceptives.". Patient recovered.

HPV (GARDASIL) Side Effects Report #349527
HPV (GARDASIL) vaccine side effect was reported on 06/16/2009. Female patient, 17.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Fatigue, "Pt. had fainting episodes with 1st dose of GARDASIL on 4/7/09. With this 2nd GARDASIL & within seconds pt. got pale, as she was laying down her eyes rolled back, got stiff & shook about 2-3 times. Resolved quickly. Physician came immediately & saw her recovered. Episodes of vomiting for 1 hr. Pt home. 9/22/09-records received for dates of service-6/26/09-8/13/09-neurology consult-evaluation for 2 episodes associated with Gardasil. Blacked out at time of injection-body stiffening and shaking eyes deviated upward. First event 4/7/09 C/O felt weird and ears heard rushing unable to see as black came into her vision. C/O being hot, lost consciousness and was limp. Confused regarding circumstances-no change in mental status. 2nd event 6/15/09-lost consciousness, stiffening and shaking of whole body, weak afterward, pale and greenish. Vomited. C/O abdominal pain and bothered by smells, dizzy and short of breath wi th stairs. Appetite decreased for 6 days. Follow-up visit 8/13/09-no further episodes of loss of consciousness or seizures. C/O vision will become black when changing from sitting to standing. C/O tired. Long history of being tired. Assessment: most likely represented convulsive syncope particulary given her history of other vasovagal presyncopal events." NoneNoneNo 9/22/09-records received- EKG sinus arrhythmis. EEG normal. Labs WNL. . During the same period patient was treated with None. Patient recovered.

HPV (GARDASIL) Side Effects Report #349667
HPV (GARDASIL) vaccine side effect was reported on 06/19/2009. Female patient, 16.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Fatigue, "Information has been received from a consumer concerning her approximately 17 year old daughter with no medical history or allergies who was vaccinated with three dose of GARDASIL. Concomitant therapy included ~LOLESTRA~. The consumer reported that after receiving the first and second dose of GARDASIL the patient experienced injection site soreness but then was fine. Then about three weeks after receiving the third dose of GARDASIL. The patient experienced bruising in her leg which caused immobility, which they thought was a blood clot so they took her to the emergency room and had to stabilize her leg and then shortly after the bruising cleared up. Then in September 2008 the bruising came back in her leg and starting in November 2008 the patient started to get sick constantly. The patient could not move, was very exhausted, lost about 7 pounds, could not eat, and had breathing problems. The patient was taken to a pulmonologist because her pediatrician thought she may have walking pneumonia, mono or asthma, but they were all ruled out. Then the patient was taken to a physician who ran a bunch of blood test, and computerized tomography scan (CT) of her brain and a magnetic resonance imaging (MRI) of her left leg. The MRI and CT scan came back fine, but the physician stated that through the blood work the patient's immune system was compromised and believed it was from GARDASIL ~ The patient then started to get a lot of sinus infections and developed cyst in her sinus so she had out patient surgery (name of hospital, address and phone number unspecified).~ The consumer reported that in mid May 2009 the patient developed mono and had been doing better but still got exhausted pretty fast, and had missed about 45 days of school this past school year. The patient was seen by the pediatrician to seek medical attention. At the time of report, the patient was recovering. Upon internal review, mononucleosis and bruising in leg were considered to be disabling. Additional information has been requested. 7/24/09 Clinical s" "None PMH: scoliosis, costochondritis, sinusitis, pahryngitis, back pain, abdominal pain""magnetic resonance, fine; head computed axial, fine; hematology, immune system is compromised. Labs: Spirometry WNL. O2 sat 97% on RA. H. pylori (+). Abd US WNL." . Patient recovered.

HPV (GARDASIL) Side Effects Report #350021
HPV (GARDASIL) vaccine side effect was reported on 06/24/2009. Female patient, child 12.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Fatigue, "Mom stated Pt developed hearing loss to both ears Dec 07 shortly after completing GARDASIL series. Dose #1 1/23/07 - Dose#2 3/29/07 - Dose#3 8/6/07 - Pt now wears hearing aids. 7/8/09 Medical records received DOS 8/6/07 to 6/24/09. Assessment: Hearing impaired in both ears. Patient's parent reports that child has failed school hearing test, now wears hearing aids. Acne, headaches, fatigue. Palpitations. Urinating more frequently. Dizziness. Mood swings. Menstrual cycles heavy and irregular. Thoracic spine, mild curvature to the left." acne; finger injury7/8/09 Medical records received DOS 8/6/07 to 6/24/09. ADD. Ingrown toenail. Acute bronchitis. Allergic rhinitis.failed school hearing test . During the same period patient was treated with ADDERALL XR. Patient recovered.

HPV (GARDASIL) Side Effects Report #350121
HPV (GARDASIL) vaccine side effect was reported on 06/19/2009. Female patient, 16.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Fatigue, "pt sits on exam table - gave MENACTRA im to LD then HPV im RD. A few second later patient feels dizzy and passed out and lying on exam table, for about one minute then awake and talking but feeling tired. Apply O2 P = 64 BP = 100/64 observe 15 mn then discharge home in a good condition fully awake." NoneNone . During the same period patient was treated with None. Patient recovered.

HPV (GARDASIL) Side Effects Report #350543
HPV (GARDASIL) vaccine side effect was reported on 06/28/2009. Female patient, 14.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Fatigue, "Faints - blacks out - low blood pressure. Extreme pain in legs and body. Body jerks no concentration brain fog. Rashes, joint pain Fatigue, constipation weight loss - nausea. Headaches bedridden long periods. 7/20/09 Hospital records received DOS 7/18/08 to 7/13/09. Assessment: Orthostatic hypotension and Fibromyalgia. Syncope and Collapse. Migraine. Aversion to eating. Chronic pain syndrome. Multiple ER visits and hospitalizations. Chronic diarrhea and dizzy spells. Decreased PO intake. Weight loss. Headache, blurry vision. Mental status change. Confusion, inability to eat. Uncontrolled pain. Loss of consciousness. On birth control pills. Constipation. 9/4/09 Received ICD9 codes: 4516; 43239; 4580; 7291; 27651; 78701; 78321; 78052; 3384; 56400; 2871. 7/1/09 Medical records received DOS 6/20/07 to 12/24/07 Assessment: Fatigue, arthralgia, myalgia, easy bruising, lack of concentration. Patient presnts with lower leg pain, aching, sore arms, ankle bruising. Heavy menstrual period. Lack of concentration. Allergies. Painful skin with light touch. Constipation, SOB with excercise. Illness at time of immunization: Tired, not sleeping well. Body aches. Stress at school. Sore throat, Amox." None"None. 7/20/09 Hospital records received DOS 7/18/08 to 7/13/09. Fibromyalgia/chronic pain, platelet dysfunction, Lyme disease, orthostatic hypotension. Allergy to Stimate. Head trauma. Leg injury. Irregular menses. 7/1/09 Received medical records w/PMH: Excercise-induced asthma."7/20/09 Hospital records received DOS 7/18/08 to 7/13/09. LABS and DIAGNOSTICS. Upper GI Series Normal. Abdominal Ultrasound Normal. CBC Normal. Metabolic Panel Normal. MRI/MRA Normal. Cortisol Stimulation Test WNL. Lyme titer - Borderline . During the same period patient was treated with None. Birth control pills.. Patient was hospitalized Patient recovered.

HPV (GARDASIL) Side Effects Report #350708
HPV (GARDASIL) vaccine side effect was reported on 07/02/2009. Female patient, 21.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Fatigue, "6/15/09 Pt. to clinic to receive HPV #2. Pt described symptoms after receiving first GARDASIL IZ within 2 hours after injection experienced fever, gastric distress, fatigued & SOB. Went to ER had to wait 5 hours & was not seen. Symptoms resolved." NKDA . Patient recovered.

HPV (GARDASIL) Side Effects Report #350931
HPV (GARDASIL) vaccine side effect was reported on 07/07/2009. Female patient, 18.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Fatigue, "7/01/2009 Dr. reported that patient had syncope x 2, tiredness, dizziness, swollen/rash on face on 7/1/09 at 1630. Pt. passed out and injured self. Dr. reported left leg paresthesia and twitching." UNKNOWNUNKNOWNUnknown . During the same period patient was treated with NONE. Patient recovered.

HPV (GARDASIL) Side Effects Report #351066
HPV (GARDASIL) vaccine side effect was reported on 07/09/2009. Female patient, 14.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Fatigue, "Extreme fatigue (sleeping 20-22 hours per day). In Jan. she started to throw up, on 1/19 she had a migraine symptom that was painful and affected her vision for 3 days, vomiting continued for 5 weeks, then fainting started and lasted for a week, extreme fatigue and underlying headache during all this time. In end of April, headache stopped, but fatigue continued. In Jan. patient had a CT scan, EKG and blood work, along with an ophthalmologist appt. In Feb. she got the 2nd dose of Gardasil (we didn't know what was wrong with her). She had an upper GI in Feb. In March she had an endoscope, ultra sound of all her organs, MRI, EEG and more blood work. We are currently seeing a naturpath Dr. trying to ~detox~ her. 9/22/09 School medical records received DOS 12/14/08 to 2/17/09. Several visits. Patient tired, could not function, slept all day and night, thowing up several times a day. Dizzy, sweaty, feels she will pass out. Vision blurry, poor depth perception. Migraine headache. 9/22/09 PCP medical records received DOS 12/02/08 to 6/19/09. Assessment: Complex Migraines. Patient presents with unexplained vision abnormality. Eye exam normal. Dizzy spells, headaches, vomiting, GERD, weight loss, syncope. Neurology consult - Complex Migraines - otherwise WNL." 9/22/09 PCP medical records received DOS 12/02/08 to 6/19/09. Menorrhagia. YAZ contraception."9/22/09 PCP medical records received DOS 12/02/08 to 6/19/09. LABS and DIAGNOSTICS: CHEM - Glucose 101 mg/dL (H). Biopsy - Duodenum, stomach, gastric body, esophagus - all WNL. CT Head - WNL. MRI- Negative. EEG - Normal. Multiple Positive A" . During the same period patient was treated with YAZ (drospirenone & ethinyl estradiol). Patient was hospitalized Patient recovered.

HPV (GARDASIL) Side Effects Report #351067
HPV (GARDASIL) vaccine side effect was reported on 07/09/2009. Female patient, 13.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Fatigue, "Coughing, trouble breathing, loss of voice, malaise, crying, headache, chest discomfort, pain at injection site with swelling, dizziness, abdominal pain, weakness, fatigue, restless legs. 7/10/09 Received ER medical records of 5/10/2007. FINAL DX: laryngitis Records reveal patient had chest congestion, dry cough, abnormal taste x 1 week. Seen by PCP & dx w/allergies. OTC allergy med not helpful. Tx w/oral antibiotics & cough syrup. D/C to home w/PCP f/u. 11/23/09 Merdical recs received for date 5/7/07. OV for c/o sore throat. DX: postnasal drip. OV 5/14/07 c/o sore throat f/u ER visit. DX: postnasal drip." NonenoneLABS: CXR WNL. . Patient recovered.

HPV (GARDASIL) Side Effects Report #352171
HPV (GARDASIL) vaccine side effect was reported on 07/15/2009. Female patient, 19.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Fatigue, "Information has been received from a physician concerning a 19 year old female who about a year ago (in approximately 2008) was vaccinated with the third dose of GARDASIL (dose, route and lot number not reported). The physician reported that the patient's mother reported to him that soon after receiving the third dose of GARDASIL (in approximately 2008), the patient experienced nausea, weight loss, fatigue and joint pain. The physician reported that the patient was sent to see a rheumatologist and the results came back fine. The physician reported that the patient had recovered and was fine. The patient sought medical attention by contacting the physician. Additional information has been requested." UnknownUnknown . During the same period patient was treated with Unknown. Patient recovered.

HPV (GARDASIL) Side Effects Report #352326
HPV (GARDASIL) vaccine side effect was reported on 07/15/2009. Female patient, 26.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Fatigue, "Information has been received from a registered nurse concerning a 26 year old female who on 25-JUN-2009 was vaccinated with the first dose of GARDASIL (lot# 662518/0087Y, 0.5ml, route and site of administration not reported). Concomitant therapy included (ZOLOFT), amphetamine (ADDERALL TABLETS), (XANAX), (AMBIEN), (CLEOCIN) and (NUVARING). The patient's relevant medical history and past drug history were unknown. On 25-JUN-2009 the patient reported feeling weak, tired and mentally slow. As of 25-JUN-2009 the patient was still feeling weak, tired and mentally slow. It was unknown if the patient would continue to take the GARDASIL vaccine. Additional information has been requested." UnknownUnknown . During the same period patient was treated with XANAX; ADDERALL TABLETS; CLEOCIN; NUVARING; ZOLOFT;AMBIEN. Patient recovered.

HPV (GARDASIL) Side Effects Report #351972
HPV (GARDASIL) vaccine side effect was reported on 07/20/2009. Female patient, 13.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Fatigue, "Information has been received from a consumer concerning a 14 years old female with a history of tubes in ears when little and adenoids removed at age 2 years old and no drug reactions who on 13-NOV-2007 was vaccinated with the first dose of GARDASIL. There was no concomitant medication. The patient received the 2nd dose of GARDASIL on 16-JAN-2008 and the 3rd dose of GARDASIL on 23-MAY-2008. At the beginning of February 2009, the patient experienced weakness, pain, tiredness, terrible leg pain, shortness of breath, muscle weakness, every now and then the stomach bothers her, fever, and headache. The patient had been seen in the office and hospitalized. The patient has been in and out of the hospital. The unspecified physicians at the hospital thought the patient had Guillain Barre but later determined it is not. Two spinal taps, 3 CT scans, MRI, numerous X-rays and blood panels were performed. The results showed that there was protein in the spinal fluid. The patient is better but every now and then there is muscle weakness and joint pain throughout both arms, both legs and both feet. The patient was homebound for the rest of the school year and missed school from February to March in 2009. The patient was at the hospital with 17 different physicians. Weakness, pain, tiredness, terrible leg pain, shortness of breath, muscle weakness, stomach bothers her, fever, headache and joint pain throughout both arms, legs and feet were considered to be disabling and immediately life-threatening. Follow-up information has been received from a medical assistant concerning a 14 years old female who on 13-NOV-2007 was vaccinated with the first dose of GARDASIL (lot# 657737/0522U). The patient received the 2nd dose of GARDASIL (lot# 657737/0522U) on 16-JAN-2008 and the 3rd dose of GARDASIL (lot# 658094/0524U) on 23-MAY-2008. No other vaccines were administered at the time of the GARDASIL dose. A lot check has been initiated. Additional information has been requested. 7/24/09 MR received from PCP from 11/2007 to 4/13/09. In f" "Ear tube insertion; Adenoidectomy. 8/6/09 Multiple hospital inpatient, DC summary, and ER records. Ear infection, tonsillectomy, adenoidectomy. Recent URI. PMH: Pharyngitis. OM. Diarhea. HSV1. Hand pain. weight gain. Dysthymic disorder . Ear tubes. Family hx of CMT.""Spinal tap, there was protein in the spinal fluid. 8/6/09 Multiple hospital inpatient, DC summary, and ER records. LABS and DIAGNOSTICS: CBC - WBC 2.61 K/mm3 (L) Mono 14% (H). Urinalysis - protein trace, blood trace, WBC 6 /hpf (H), RBC 13" . During the same period patient was treated with None. Patient was hospitalized Patient recovered.

HPV (GARDASIL) Side Effects Report #352152
HPV (GARDASIL) vaccine side effect was reported on 07/22/2009. Female patient, 21.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Fatigue, "Seizures, Slurred speech, Dizziness, muffled hearing, blurred vision, involuntary joint movement, easily frustrated, muscle spasms, taste and memory disturbances, loss of sleep, extreme stress and anxiety related to symptoms and treatments. 7/23/09 Consultant records received DOS 7/31/07 to 7/13/09. Assessment: Partial seizure emanating from the left hemisphere. Patient ~felt like something would happen~ Then unable to speak appropriately, jumbled words, could not speak properly. Right arm made involuntary movements, felt like she was out of her body. Make loud noises. Hearing felt muffled. Felt on edge and not as sharp for 24 hours. Slightly mumbles, tired at times. Recurrent episode. Blotches in vision, headache. Agitated, irritability - Keppra. ICD-9 Code: 345.11, 780.39, 784.0 7/28/09 Medical records received DOS 5/30/07 to 1/29/09. Patient requests Gardasil vaccine. 1st dose of Gardasil given. Oral contraceptive changed from Desogen to Seasonique. Has had two seizures, on Keppra. 2nd, 3rd doses of Gardasil given. Denies any side effects from this medication (Gardasil)." N/AN/A 7/28/09 Medical records received DOS 5/30/07 to 1/29/09 Caffeine."MRI, Multiple EEG, Multiplte Doctor Visits, all from having to traveling long distances. 7/23/09 Consultant records received DOS 7/31/07 to 7/13/09. LABS and DIAGNOSTICS: MRI - Normal. MRI angiogram normal. WBC / CBC normal. Comprehensive" . During the same period patient was treated with N/A 7/28/09 Medical records received DOS 5/30/07 to 1/29/09. Oral contraceptives. Oral contraceptive changed from Desogen to Seasonique.. Patient recovered.

HPV (GARDASIL) Side Effects Report #352421
HPV (GARDASIL) vaccine side effect was reported on 07/27/2009. Female patient, 17.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Fatigue, "Nausea & vomiting, abdominal pain, joint pain, numbness & tingling in hands & feet, fatigue, weight loss. Unable to eat certain foods. Developed allergy to wheat. These symptoms started 1 to 2 weeks after 1st vaccine. Pt stated felt like ~she was 80 yrs old.~ Started wheat free diet, visited doctor, lab tests for celiac disease negative, numerous lab tests (lyme titer, cbc, rheumatoid workup, ANA, Sed rate, lupus and all negative. 2 months after vaccine peripheral neuropathy, joint pain symptoms improved. Continues with abdominal pain, weakness, weight loss & difficulty with foods. Diarrhea begins and continues to present. Work up by GI specialist includes EGD, colonoscopy, CT's, MRI, GI series, video capsule endoscopy, numerous lab studies. Allergy testing showing allergy to wheat. Positive for fructose malabsorption. Wheat free & fructose free diet. Work up continues after 1 year to find source of abdominal pain and watery diarrhea. 7/30/09 PCP records received 7/11/08 to note written 7/28/09. Initially presented 7/11/08 request to be tested for celiac disease. Reports 2 yr hx of abdominal pain, recently improved on wheat-free diet. Returned 8/11/08 with c/o 2 months hx of ~everything hurting~- joints and muscles, fatigue, decreased sleep, sensitive hearing. Labs all WNL except (+) EBV Ab IgG showing recent infection. 10/8/09 Hospital records, DC summary received, service dates 3/16/09 to 3/18/09. Assessment: Chronic complex of abdominal pain with diarrhea. Patient developed myalgias, asthenia, fatigue, arthralgias, nausea and vomiting - now resolved. Lost weight. Constipated. Patient now presents with abdominal pain and postprandial diarrhea. Abdomen - diffuse tenderness to palpation. ICD-9 Codes: 564.1 Irritable bowel syndrome, 787.91 Diarrhea." Pectus Excavatum PMH: abdominal pain. 10/8/09 Hospital records 3/16/09 to 3/18/09. Blastocystis hominis infection. Possible Joubert's Syndrome.Small bowel biopsy with intraepithelial lymphocytes. Labs: EBV IgG (+). 10/8/09 Hospital records 3/16/09 to 3/18/09. LABS and DIAGNOSTICS: CT Scan Abdomen/Pelvis - Abnormal. . Patient was hospitalized Patient recovered.

HPV (GARDASIL) Side Effects Report #352481
HPV (GARDASIL) vaccine side effect was reported on 07/22/2009. Female patient, child 2.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Fatigue, "Fever to 102 degrees F nausea, vomiting -> (severe) dizziness, rapid heartbeat, rash, aches/pain in legs, knees, ankles, weakness/ extreme fatigue. Onset about 6-7 hours after inoculation, treated with TYLENOL, MOTRIN, Dr. prescribed ZOFRAN for nausea. 6 PM through the night. Fever broke by 10 am following day" NoneAsthmatic . Patient recovered.

HPV (GARDASIL) Side Effects Report #352518
HPV (GARDASIL) vaccine side effect was reported on 07/24/2009. Female patient, 26.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Fatigue, "Information has been received from a physician concerning a 26 year old female with no known allergies or reported medical history who on 07-JAN-2009 was vaccinated with the first and only dose of GARDASIL (lot# 661531/1311X) 0.5 ml, I.M. route. Concomitant therapy included NECON 1/35. On 08-APR-2009, the patient experienced deep vein thrombosis. The patient was treated with anticoagulation therapy including LOVENOX and COUMADIN. Subsequently, the patient was recovered. The physician stated that ~clots can be dangerous~ and deep vein thrombosis was considered to be immediately life-threatening. Additional information has been requested. 8/10/09 ER Records received DOS 4/9/09. Assessment: Soleal vein thrombosis left mid calf. Patient presents with pain of left calf exacerbated by walking/movement. Stopped taking birth control pills today. 8/17/09 Consultant records received DOS 4/13/09 to 6/04/09. Assessment: Acute DVT left perineal and soleus veins. Patient reported to physican's office with left leg pain and was sent to ER for initiation of therapy for DVT. Placed on anticoagulation. Sent to consultant's office for follow-up. Presents with left calf tenderness. Urinary tract infection. left ear pain, congested, pressure and slight dizziness. Increased anxiety. Fatigue. Tympanic membranes show serous fluid accumulation." "Unknown. 8/10/09 ER Records received DOS 4/9/09. Alcohol use, Smoker, UTI, Acne, HPV. 8/17/09 Consultant records received DOS 4/13/09 to 6/04/09. Urinary tract infections. Smokes."Unknown. 8/10/09 ER Records received DOS 4/9/09. LABS and DIAGNOSTICS: Venous Doppler Study - Abnormal. 8/17/09 Consultant records received DOS 4/13/09 to 6/04/09. LABS and DIAGNOSTICS: Positive Doppler report with extension of DVT. INR 2 . During the same period patient was treated with NECON 1/35. Patient recovered.

HPV (GARDASIL) Side Effects Report #352921
HPV (GARDASIL) vaccine side effect was reported on 08/02/2009. Female patient, 19.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Fatigue, "After first gardasil shot on 03/27/08 my symptoms included: Pain in my arm, dizziness, acute pharyngitis, sore joints and mucles. After my 2nd Gardasil shot on 05/27/08 my symptoms were arm was sore, dizzy, weak, fatigued, whole body ached, severe lower pelvic pain a couple times, Flue off and on, colds, acute pharyngitis a few times, ear aches and infections, sore joints, back and neck pain, headaches off and on, IBS with constipation and bouts of diarrhea,had colonoscopy done, frequent UTI's, kidney infection, hard to concentrate, confusion, had rash on left shoulder for awhile then went away,sensitivity to light, racing heart sometimes, when dizzy my palms sweat, I become clumsy and heart races, grinding teeth, and on 05/29/09 went to OBGYN for Yearly Pap smear and every year it has been normal, no problems but this year, one year after I had my second Gardasil shot the results came back as abnormal. Showed HIGH GRADE SQUAMOUS INTRAEPITHELIAL LESION moderate dysplasia CIN 2. Doctor then gave me a colposcopy on 6/26/09 my protien level in urine was high +3 as well said I had ACUTE CERVICITIS. Then had Leep Biopsy done on 7/15/09 for the HIGH GRADE SIL the results were, I had HIGH GRADE SQUAMOUS INTRAPITHELIAL LESION CIN 3 SEVERE DYSPLASIA. They removed all abnormal cells. now bleeding on and off. Been on antibiotics 6 different times in one years time since I had the Vaccine. Never got sick before the shot. I believe these symptoms are caused by the Gardasil Vaccine. I believe I might have something wrong with my immune system or nervous system now. 8/5/09 PCP medical records received DOS 08/16/06 to 7/20/09. Assessment: Acute Cervicitis. High Grade Squamous Intraepithelial Lesion (CIN 3, Severe Dysplasia of Cervix. Patient presents with sore throat, productive cough, and sinus drainage. Oral contraceptives. Pharyngitis. Ear ache. Hurts to swallow. Neck anterior lymphadenopathy. Strep throat. Fatigue, headaches, needing more sleep at night. Bronchitis, chest discomfort with hx of rib contusions. Constipat" nonenone. 8/5/09 PCP medical records received DOS 08/16/06 to 7/20/09. Eye surgery. Caffeine use. Pelvic pain. Oral contraceptives. Penicillin allergy. Hives. Bacterial vaginosis"pap smear,leep biopsy, colposcopy, CBC was normal but Glm filtration Rate, Es was 70 normal is 60,strep screen negative, mono screen negative,colonoscopy, UA showed glucose at 250, bilirubin LARGE, ketones 15, specific gravity <1.005, blood" . During the same period patient was treated with Birth control pills thats it.. Patient recovered.

HPV (GARDASIL) Side Effects Report #353037
HPV (GARDASIL) vaccine side effect was reported on 07/24/2009. Female patient, 15.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Fatigue, "7/22 Woke up during the night from a really bad sharp pain in chest. She barely touched it and the sharp pain would return same with shoulders. 7/22 Tired and sore from therapy. I want to give a little history on this patient. She was a cheerleader, majorette, and was in a weight lifting class. She was very active and athletic. I didn't have enough room on the VAERS for this so I am attaching this sheet for a timeline. 10/14/08 1st GARDASIL. 12/29/08 2nd GARDASIL. 01/09 School reported she was generally weak and fatigued to the point of needing to leave school. 02/09 She started with having leg weakness and would like wrap her ankles for performances and practices (no injuries) just weakness. 03/09 The actual leg and joint pain started. She was refusing to do stunts in cheerleading because it hurt so bad. She is the ~flyer~ because of her small size and she said it hurt too bad to climb up and to be caught. 04/09 Not a lot of activity during the month with cheering or anything, but she had to be picked up from school several times because the exertion just from walking from class to class made her so tired she had to go to bed. 05/09 The week of the 11th she had to be picked up from school because of lethargy just from decorating for the prom. The week of the 18th she started with a limp more prominent in the R leg. Substantially increased pain in the joints and ~shooting, needle-stick pains in the shin area~. The following week she started losing muscle control and could not walk or stand without help and started using crutches. She complained of ~burning, stabbing, achy~ pains in many different areas. Her hips, arms, and leg muscles had significantly increased pain. Because of the severity of the pain and loss of muscle control in her legs, she was taken to ER on May 31. She was sent to hospital at that time. 06/09 She went to an Orthopedic Dr and they said it was neurological. She started seeing a Neurologist, she was doing MRI's and further testing and they couldn't find anything so they are sending her to a" noneheart murmurPlease see attached . Patient recovered.

HPV (GARDASIL) Side Effects Report #353069
HPV (GARDASIL) vaccine side effect was reported on 07/24/2009. Female patient, 16.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Fatigue, "I want to give a little history on this patient. She was a cheerleader, majorette, and was in a weight lifting class. She was very active and athletic. I didn't have enough room on the VAERS for this so I am attaching this sheet for a timeline. 10/14/08 1st GARDASIL. 12/29/08 2nd GARDASIL. 01/09 School reported she was generally weak and fatigued to the point of needing to leave school. 02/09 She started with having leg weakness and would like wrap her ankles for performances and practices (no injuries) just weakness. 03/09 The actual leg and joint pain started. She was refusing to do stunts in cheerleading because it hurt so bad. She is the ~flyer~ because of her small size and she said it hurt too bad to climb up and to be caught. 04/09 Not a lot of activity during the month with cheering or anything, but she had to be picked up from school several times because the exertion just from walking from class to class made her so tired she had to go to bed. 05/09 The week of the 11th she had to be picked up from school because of lethargy just from decorating for the prom. The week of the 18th she started with a limp more prominent in the R leg. Substantially increased pain in the joints and ~shooting, needle-stick pains in the shin area~. The following week she started losing muscle control and could not walk or stand without help and started using crutches. She complained of ~burning, stabbing, achy~ pains in many different areas. Her hips, arms, and leg muscles had significantly increased pain. Because of the severity of the pain and loss of muscle control in her legs, she was taken to ER on May 31, She was sent to hospital at that time. 06/09 She went to an Orthopedic Dr and they said it was neurological. She started seeing a Neurologist, she was doing MRI's and further testing and they couldn't find anything so they are sending her to another Neurologist (08/14/09). She also started losing clumps of hair, not sure of the actual date but it started in June and is worsening some throughout the month of July with a" noneheart murmursee attached . Patient recovered.

HPV (GARDASIL) Side Effects Report #353070
HPV (GARDASIL) vaccine side effect was reported on 07/24/2009. Female patient, 15.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Fatigue, "1/08 - school reported she was very weak - 03/09 leg weakness/tired 03/09 pain started. Please see attached. Patient continuity codes to 353037 and 353069. VAERS report received with MR and notes from PCP. Pt developed weakness and fatigue shortly after 2nd HPV vax on 12/2908. ADLs greatly reduced due to lethargy and fatigue. Developed joint pain and pins & needles shin pain and loss of muscle control in 5/2009 Walked with a limp 2' to pain. See ER notes. Neuro consults with no specific dx. Referred to another neuro and will be seen 8/2009. In June 2009 developed hair loss. Following 3rd HPV shot 7/14/09 developed sharp chest and shoulder pain, fever, nausea and stomach pain, worsening pain in fingers, thrumb, wrist, elbow and arm. 8/28/09 ER records rec'd for DOS 5/31/09 with DX: Acute lower extremity sense of weakness. Acute LE paresthesias. Presented with c/o joint pain and weakness in legs since 5/18/09. Unable to walk. sharp pains in shins and thighs. Occ feels like airway is closing. PE (+) stiff-legged, wide-based gait. Referral notes EKG abnormality, lower extremity strength 3/5, upper extremity 4/5. Referral made for outpt PT. 10/8/09 Neurology consult, rheumatology consult, pediatric pain service records received, service dates 8/14/09 to 10/1/09 Assessment: Diffuse musculoskeletal pain, amplified pain. Abnormal ESR. Chronic steroid use. Patient presents for evaluation of diffuse pain. Intermittent activity-dependent fatigue and generalized weakness, Aching pain entire body. Transient swelling of face and hands. Jaw aches after chewing. Activities limited. Uses cane or wheelchair for walking more than a few steps. Occipital headaches. ~Crouched~ gait. Brief cervical lymphadenopathy. On corticosteroids - Cushingoid face and 30 lb undesired weight gain, sleep disturbances. Muscle tenderness and tender points. Antalgic gait. Episode of severe chest pain." None"Heart murmur PMH: low K+. 10/8/09 service dates 8/14/09 to 10/1/09. Presyncope, low serum potassium. Frenulectomy."Labs: CSF WNL. ESR 38. EKG WNL. 10/8/09 service dates 8/14/09 to 10/1/09. LABS and DIAGNOSTICS: CDC - WBC 27.7 thou/uL RDW 14.7% (H) Neut 67.5% (H) Neut 17.36 thou/uL (H) Lymph 6.38 thou/uL (H) Baso 0.00 thou/uL (L). EBCAgG (+) EBAgAB ( . Patient recovered.

HPV (GARDASIL) Side Effects Report #353200
HPV (GARDASIL) vaccine side effect was reported on 08/05/2009. Female patient, child 12.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Fatigue, "Mother brought child to HD office 8/3/09 PM to report that child's arm became tender, with redness over deltoid spreading to just aboeve the elbow PM 7/31/09. c/o being tired and ~just not feeling well~ continuing today. there had been a ~knot~ in her arm, but it is now gone. Did not check for fever. Gave Ibuprofen, used cool compress off and on for 2 days." NONENONE REPORTEDNone . During the same period patient was treated with NONE. Patient recovered.

HPV (GARDASIL) Side Effects Report #353217
HPV (GARDASIL) vaccine side effect was reported on 07/31/2009. Female patient, 20.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Fatigue, Severe stomach pain and weakness. Very tired and barely able to get out of bed. Kidney pain. . Patient recovered.

HPV (GARDASIL) Side Effects Report #353282
HPV (GARDASIL) vaccine side effect was reported on 08/04/2009. Female patient, 14.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Fatigue, Severe fatigue and soreness. asthma; allergies . Patient recovered.

HPV (GARDASIL) Side Effects Report #353307
HPV (GARDASIL) vaccine side effect was reported on 08/06/2009. Female patient, 14.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Fatigue, "7/27/09 Came in to HD c/o side effects since vaccination. Symptoms: dizziness (7/16/09), vomitting (7/22/09), passed out (7/23/09), hives on chest, remains weak and tired. Referred to MD. Note: Patient also participates in band practice" nonenoneNone . Patient recovered.

HPV (GARDASIL) Side Effects Report #353315
HPV (GARDASIL) vaccine side effect was reported on 08/06/2009. Female patient, child 12.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Fatigue, "On 11/16/08, pt went about her day as normal, but became very tired quite suddenly around 5:00 in the evening. She went to bed to rest (something she rarely did until this point). After a couple of hours we attempted to wake her to attend church, a favorite activity, and she wanted to continue sleeping. We let her sleep until the next morning. We made her get up and prepare for school, but before she left, she complained of tiredness, headache, and sore throat, and we allowed her to stay home from school. She remained in bed for ten days, only getting up to go to the bathroom, shower, or go to the doctor. We encouraged her to sit up in a chair or even lie down in another room to help increase her energy level, but she did not have the strength for more than a few minutes. During this time the headache and sore throat remained, along with upper abdominal pain (left side right under ribs). The symptoms gradually improved, and pt was much better by the end of the first week of December. From then until the middle of January, pt continued to report mild symptoms, including fatigue and abdominal pain, but she was able to go about her normal activities. In mid January, pt came home from school, went to bed, and would not get up until morning. She went to school the remainder of that week with moderate symptoms, only because she was taking mid-term exams. Since then, pt has had three more occurrences of symptoms, missing one and two days of school. During these periods she has complained that light hurts her eyes. Upper abdominal pain, headaches, and sore throat recur periodically. Pt has also complained of periods of ~feeling out-of-it~, or not being able to concentrate at different times since mid-December. She has also stated that her legs ~fall asleep~ often. To the best of my knowledge, she has never had fever during this time. In July she received five injections (HPV/Meningitis/DPT/Varicella/HepA), and two in October (HPV/Influenza). Lot number for July 2008 HPV vaccine was 1757U." NoneNone"Lab tests performed, all with normal results: Monospot, EBV titers, CBC, urinalysis, pancreatic enzymes. Many other blood tests with normal results. Biopsy performed during endoscopy in June 09 showed mild chronic gastritis. Two abdominal" . Patient recovered.

HPV (GARDASIL) Side Effects Report #353615
HPV (GARDASIL) vaccine side effect was reported on 08/10/2009. Female patient, 16.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Fatigue, "Immediately following HPV#2 and Varivax #2 (10:45 am) patient fainted and fell forward off of the exam table and hit her Left cheek, ear and knee on the ground. Her ear bled at the site of her earring. After being on the ground flat she regained consciousness within 45-60 seconds. She was confused for a few moments and tearful. Ice was applied to her cheek and she stayed and was observed for 15 minutes. She was told not to drive or go to work today and to call if she had vomiting, headaches or other changes. Mom is very upset. I called at 5:30 pm and patient is napping and other than having a bruise on her cheek (not swollen) and tired has no other worrisome signs. Mom wants a CT of brain and cheek done (she works in radiology at hospital). I do not think these are warrented at this time. She is angry I won't order them now and is going to file a report with the hospital.(she says.)" mild URI with runny nose for one day.None . During the same period patient was treated with antibiotics s/p wisdom tooth extraction 5 days prior. I don't know what they are as they didn't know.. Patient recovered.

HPV (GARDASIL) Side Effects Report #353760
HPV (GARDASIL) vaccine side effect was reported on 08/11/2009. Female patient, 15.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Fatigue, "Body aches, fatigue, blisters inside mouth, swollen glands, sores on lips and gums, swollen lips." NoneNone . Patient recovered.

HPV (GARDASIL) Side Effects Report #353763
HPV (GARDASIL) vaccine side effect was reported on 08/10/2009. Female patient, 18.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Fatigue, "Severe diarrhea w/in 48 hrs. of 3rd vaccine, vomiting, chronic fatigue, headache, abdominal pain, heart palpitations, sensitivity to light & noise. All except vomiting have continued. Low grade fever of ~unknown origin~. 8/14/2009 PCP records rec'd dated 7/20-8/3/2009 with dx: Headache. Fatigue. Abdominal Pain. Pt initially presented 7/20/09 with 2 week hx of headaches and abdomminal pain. Nausea associated with abd pain. Parent reports reduced activity level. F/U 8/1/09. Tenderness to palpation in RUQ. Returned 8/3/09 with worsening sx. MD notes sx began following HPV and TDaP vax in June. Reports need frequent breaks with activity, spending days in bed 2' to fatigue, dizziness, lightheadedness, seeing spots, epigastric pain, several episodes of syncope with myoclonic movements. Referred to cardiology and neurology." "allergic to mites, molds, aged cheeses. PMH: ADD, Anxiety, Sensory integration issues, env allergies. 9/24/09 Hospital operative report DOS 6/12/09. Recurrent tonsillitis, hypertrophic tonsils. Tonsillectomy performed. 10/8/09 Neurology and cardiology consults service dates 2/6/08 to 6/1/2009. ECG - Normal Sinus Rhythm. Sleep disorder Patient presents with hypersomnolence.""CBC; sed rate checked; mono test; Lymes disease; abdominal ultrasound. Labs and Diagnostics: EEG WNL. Na+ 123, Cl- 94 both low. EBV capsid IgGAb (+), IGM (-), Nuclear IgG Ab (+)." . During the same period patient was treated with LEXAPRO-20mg; VYVANSE-30mg; YAZ. Patient recovered.

HPV (GARDASIL) Side Effects Report #353870
HPV (GARDASIL) vaccine side effect was reported on 08/11/2009. Female patient, 14.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Fatigue, "Information has been received from a physician concerning a 14 year old female with no pertinent medical history and no known drug allergies (NKDA) who on 04-NOV-2008 was vaccinated with the first dose of GARDASIL (lot# 660518/0572X, dose and route not reported) and a dose of VARIVAX (Merck) (661668/1194X, dose and route not reported). Concomitant vaccination on 04-NOV-2008 included hepatitis A virus vaccine (unspecified) (lot# AHAVB264AA) and FLUMIST (LOT# 500570P). The patient was vaccinated with the second dose of GARDASIL (lot# 660616/0570X, dose and route not reported) on 10-JAN-2009 and the third 0.5ml dose of GARDASIL (lot# 661846/1312X, injection) on 14-MAY-2009. The patient's first seizure was on 04-MAY-2009 (prior to the third dose of GARDASIL). A computed axial tomography (CT) scan done that day was negative. The patient was not admitted. The patient's next seizure (gran mal) was on 19-MAY-2009. An electroencephalography (EEG) done on that day was abnormal, showing spikes in the left anterior region supportive of seizure disorder. The patient was not admitted again. The patient went on to have additional seizures in the latter part of July 2009, for which she was admitted to hospital and was diagnosed as epileptic syndrome. On unspecified day, a magnetic resonance imaging (MRI) was performed but the results came back clear. Length of hospital stay was unknown. At the time of reporting, the patient was recovering. The patient was being treated with DILANTIN and TOPAMAX and being followed by neurology. It was reported that the condition was not considered life threatening. The physician could only say that the patient found it was hard to read regarding disability. Upon internal review, seizure and gran mal seizure were determined to be other important medical events. Additional information has been requested. 8/14/09 PCP and ER records received DOS 3/28/05 to 7/30/09. Assessment: Localization related epilepsy of left frontal origin. Breakthough Seizures. Subtherapeutic antiseizure levels. 5/04/09 -" "None. HPV #3 given 5/14/09, Lot # 1312X, LA. 8/14/09 PCP and ER records received DOS 3/28/05 to 7/30/09. Fever, congested, coughing. Pharyngitis. Allergies - pollen.""Computed axial, 05/04/09, negative; Electroencephalography, 05/19/09, abnormal, showing spikes in the left anterior region supportive of seizure disorder; Magnetic resonance, clear. 8/14/09 PCP and ER records received DOS 3/28/05 to 7/30" . Patient was hospitalized Patient recovered.

HPV (GARDASIL) Side Effects Report #354303
HPV (GARDASIL) vaccine side effect was reported on 08/16/2009. Female patient, 25.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Fatigue, "Within one week of receiving the first shot (10/24/2007), I experienced flu-like symptoms, fever, and such severe vaginal discomfort that I went to the emergency room. I was diagnosed with bacterial vaginosis. It cleared up, but my health felt off - worse digestion, I started getting heartburn, feeling fatigue, started seeing floaters in my vision and getting terrible headaches, and my menstrual cycle started becoming more irregular. I had always been like clockwork. I started losing weight, which was unusual, as I had always been overweight and had a hard time losing weight. I began feeling more and more irritable, but made no connections to the Gardasil shot. In March, immediately after receiving the second vaccine (3/17/08), my arm hurt terribly, I felt lightheaded, woozy, and had hives appear. Within 1 week, I started experiencing vaginal irritation again, fever, and had flu like symptoms. Over the course of the next month, I started to feel such severe fatigue, stomach aches, and uncontrollable diarrhea, that I went to my doctor. She told me I probably just had acid reflux. Two days later, I experience debilitating stomach pain, which lasted for nearly 1 month. I had an endoscopy, a CT scan, allergy tests, and blood work for thyroid disorders and other imbalances, all of which have come back reasonably normal and regular for my body and system. I did have some esophageal damage from acid reflux, and was put on Prevacid. Receiving no answers from the clinic, I cut out gluten, corn, soy, dairy, eggs, caffeine, alcohol, yeasts, and sugar from my diet and started working with an acupuncturist and naturopath. Stool sampling showed signs of Candida Yeast overgrowth in my intestines and parasites, which I am combating naturally with help from my naturopath, and managed to eliminate with diets and supplements after 9 months of treatment. I a got off the Prevacid successfully with her help, and am starting to feel stronger. All total, after the vaccines, I experienced extreme weight loss (50 pounds), hair loss, fa" none"none PMH: smoker, nut allergy.""Endoscopy, CT Scan, MRI, Transvaginal ultrasound, IgG and IgE allergy testing, thyroid tests, blood lipids, metabolic tests, hemogram and platelets, hepatic battery, FSH, TSH, estradiol, prolactin, progesterone, free testosterone, Candida A" . During the same period patient was treated with daily multivitamin. Patient recovered.

HPV (GARDASIL) Side Effects Report #354499
HPV (GARDASIL) vaccine side effect was reported on 08/12/2009. Female patient, 15.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Fatigue, "08/10/09 - @ approximately 3:15 pm patient had vaccinations by 5:00 pm developed fever, aches, nausea, tired. At 6:15 throat felt sore. 8/11/09 - at 6:15 AM throat felt swollen (internally.), fever (no thermometer). 08/12/09 - went to Dr. - Test influenza, no throat culture - Temp 99., patient - still felt ache and couldn't swallow Ibuprofen." HealthyDepression"Rapid influenza, Neg" . During the same period patient was treated with 100mg Sertraline daily. Patient recovered.

HPV (GARDASIL) Side Effects Report #354630
HPV (GARDASIL) vaccine side effect was reported on 08/19/2009. Female patient, 22.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Fatigue, "Pt. had seizure like activity after the vaccination, this was her third dose, she had no adverse reactions with the previous two. She remembers feeling tired, hungry, thirsty immediately after the vaccination and she felt faint and fell to the floor, where she was found by a nurse to have jerking movements of her limbs and she was making moaning noise, her eyes were rolled up, she dis not recall this after, the jerking resolves in 1 minute ans she was fully awake and alert after that, she denied feeling tired, no headaches, vision changes, there was no bowel or bladder incontinence with it. Her vital signs were stable." "Tic disorder, OCD, Anxiety disorder" . During the same period patient was treated with Tenex. Patient recovered.

HPV (GARDASIL) Side Effects Report #354639
HPV (GARDASIL) vaccine side effect was reported on 08/01/2009. Female patient, 17.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Fatigue, "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." "Systemic Lupus Erythematosus; Raynaud's. 9/16/09 Rheumatology records received DOS 4/28/09 to 9/9/09. LABS and DIAGNOSTICS: ANA (+), ds-DNA 38 IU/mL (+), SSA (+), SSB (+). ESR 30 (H). C3 74 (L). Complement C4C 5 mg/dL (L). 24 hr Urine - P" . Patient recovered.

HPV (GARDASIL) Side Effects Report #354753
HPV (GARDASIL) vaccine side effect was reported on 08/14/2009. Female patient, 16.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Fatigue, "Mom states pt felt tired yesterday, light headed dizziness, fell out & lost conciosness for 30 seconds today!" NoneNone . During the same period patient was treated with VYVANSE 20mg; ABILIFY 5mg. Patient recovered.

HPV (GARDASIL) Side Effects Report #354771
HPV (GARDASIL) vaccine side effect was reported on 08/20/2009. Female patient, child 12.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Fatigue, "Initially loss of hair. Then dizziness and nausea with vomiting and severe abdominal pain. After 20 months of multiple doctor visits, Nina was diagnoses with POTS, Postural Orthostatic Tachycardia Syndrome. She is required to take meds every 3 hours including a beta blocker. She has been on homebound study for her last 2 years of school. 9/29/09 PCP medical records and multiple consultations received DOS 7/18/05 to 10/2/08. Assessment: Vestibular hypofunction. Patient presents with otalgia, ears fell clogged. Injured ankle. Pharyngitis, URI. Hair falling out, dizziness. Feels cold. Orthostatic tachycardia. Snores. Progressive fatigue. Dehydration. Sudden increased heart rate at rest with nausea. Cardiologist - Normal cardiac exam. ENT Consult performed T&A. Peripheral vestibular lesion. Vomiting, stomach pain. Neuro consult - migraine varient. Feels off balance. Otology Consult - Transient decreased hearing (R). Visual vestibular hypersensitivity. Vestibular hydrops." No"none. 9/29/09 PCP medical records and multiple consultations received DOS 7/18/05 to 10/2/08. Exercise-induced asthma. Allergic rhinitis. Allergy to household dust. 10/5/09 Vaccine records received: Hep A #1, SKB, given 10/1/08, lot# AHAVB246AA, LA. Flu shot, Conn, given 10/1/08, lot# U278414A."Tilt table test and echocardiogram. 9/29/09 PCP medical records and multiple consultations received DOS 7/18/05 to 10/2/08. LABS and DIAGNOSTICS: Normal ECG and Echocardiogram. CT Scan (-). ENG hypoactive. Audiometic - Abnormal. Rotary cha . Patient recovered.

HPV (GARDASIL) Side Effects Report #354775
HPV (GARDASIL) vaccine side effect was reported on 08/20/2009. Female patient, 14.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Fatigue, "1st vaccination was on 07/15/08, she began having muscle cramps primarily in legs. 2nd vaccination was 10/8/08 and muscle cramps extended throughout the body and much more severe. She also began loosing her ability to use her arms, hands, and legs along with fever, headaches, severe body aches, anemia, and elevated liver enzymes.By mid Dec.08 she required total care including getting dressed, putting shoes on, bathing, washing hair, etc. 8/27/09 Hospital records received DOS 1/12/09. Assessment: Dermatomyositis Patient presents with recent history of increasing muscle weakness. ICD-9 Codes: 710.3 Juvenile Dermatomyositis. 8/27/09 Hospital records received DOS 1/12/09. Assessment: Dermatomyositis Patient presents with recent history of increasing muscle weakness. PMH: Allergies - Sulfa, egg yolks. Bladder cysts. ICD-9 Codes: 710.3 Juvenile Dermatomyositis. 8/28/09 Hospital records received 2/28/09 to 3/2/09. Discharge Diagnosis: Right lower quandrant pain, dermatomyositis. Patient presented with severe right lower quadrant pain. Recent upper respiratory infection. Rash consistant with dermatomyositis. Decreased PO intake, decreased urine output. 8/28/09 PCP medical records received DOS 7/15/08 to 8/21/09. Assessment: Oral and vaginal candidiasis. Dermatomyositis. Shingles with post herpetic neuralgia/itching. Patient c/o 'real weak spells, almost passed out~. Chest hurts when coughing and inhaling. Malaise, fatigue. Swelling and red papular rash - periorbital area - since starting allergy injections. Fever. Vaginal yeast infection, thrush in mouth. Sore throat, abdominal pain. Acute sinusitis. Shingles. Otitis externa." None"None at that time. 8/27/09 Hospital records received. DOS 1/12/09. Allergies - Sulfa, egg yolks. Bladder cysts. 8/27/09 Hospital records received DOS 1/12/09. Allergy to sulfa, egg yolks. Exercise induced asthma. Frequent urinary tract infection as infant with dilation of urethra and removal of vaginal lesion, PE tubes. 8/28/09 PCP medical records received DOS 7/15/08 to 8/21/09. M""Lab results found elevated muscle enzymes, sed rate, etc. Muscle Biopsy performed at Hospital in Jan 09 resulted in a confirmed dx of Juvenile Dermatomyositis. 8/27/09 Hospital records received DOS 1/12/09. LABS and DIAGNOSTICS: Muscle B" . During the same period patient was treated with None at that time. Patient was hospitalized Patient recovered.

HPV (GARDASIL) Side Effects Report #354791
HPV (GARDASIL) vaccine side effect was reported on 08/20/2009. Female patient, 20.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Fatigue, "She started having ~seizures~ or ~staring episodes~ and her eyes started getting blurry or double vision at times in June 2008. She was so sick she was admitted to the hospital that month. The only thing they found was SVT. Feb 2009 they found she has hypoglycemia. May 2009 She started having slow speech and started dragging her left leg. June 2009 Both legs started feeling ~tingly~ and heavy- she couldn't support herself all the time. She is in a wheelchair more that not, or uses a walker the rest of the time. She can't speak at all at times- it comes out like baby jibberish or child like speach. July 2009 she started retaining water?? We noticed she had cushy bags on her back that come and go. Also that month she started ~gagging~ like she was going to throw up, but nothing comes out- except maybe a burp. Everyday she feels sick. Her life has completely been ruined becuase she is too sick to do anything. We have taken her to several types of doctors, but they said they think it is a ~conversion disorder~ because they haven't found what is causing it all. I know better than that. It is a cop-out to label it as that just because they don't know what is wrong. All these symptoms started after she had the Gardasil Vaccinations. I know this has caused the problems! 9/17/09 ER / hospital records received 4/5/08 to 5/27/09. Many visits and complaints, extensive diagnostic testing. Assessment: Left side weakness, aphasia. Conversion disorder. Originally presents with pelvic pain and a history of cysts. Epigastric pain. Right ovarian cysts. Sinus tachycardia, syncopal episode. Thyroid nodule. Patient later presents with difficulty standing, imparied speech, stuttering, difficulty walking, dragging (L) foot, weak grip. Subsequent visits: tachycardia, abdominal pain, elevated lactate. Presented to emergency room with many episodes of shaking, blurred vision, and could not talk. Begin as a ~lightness~ or ~tightening sensation~ all over body. Fever. Panic attacks. Fatigued and tired." "9/17/09 ER records received 4/5/08 to 5/27/09. Thyroid cyst. Ovarian Cyst. 10/05/09 Vaccine records received: HPV #2, Merck, given 10/15/08, lot# 1061U, RA; Adacel, Sanofi, given 10/15/08, lot# C2768BA, LA; Twinrix, given 10/15/08, no lot # provided.""3/27/08 urinalysis w/o 6/21/08- CT. 6/22/08 Echo, transthoracic (2D), doppler, cardiography color flow velocity mapping. 6/23/08 MRI brain w/o contrast-ultrasound pelvic. 6/25/08 Ultrasound soft tissue head/neck/thyroid. 7/10/08 EEG." . During the same period patient was treated with 9/17/09 ER records received 4/5/08 to 5/27/09. NuvaRing.. Patient was hospitalized Patient recovered.

HPV (GARDASIL) Side Effects Report #354798
HPV (GARDASIL) vaccine side effect was reported on 08/20/2009. Female patient, 15.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Fatigue, ON July 21 had shot. On July 26 passed out 4 times at the fair. August 3 blacked out but she said didn't pass out all the way. Aug 10 not feeling well feels tired and stomach hurts when standing. Aug 11 took to doctor. Aug 12 passed out at the mall. Always very tired. Doesn't like to eat makes her sick. Was fine before this. 9/15/09 Received vaccine & PCP medical records. Records revealed patient experienced general good health on day of HPV #1. nonenone 9/15/09 Received medical records w/PMH: Allergy: PCN."She was told she has pots disease. Urin and blood work and EKG were good. Heart rate goes way up when sitting, to standing. It was the gardasil shot. Not sure if I marked the right one. Health Unit asked me to fill this out. My doctor" . During the same period patient was treated with none. Patient recovered.

HPV (GARDASIL) Side Effects Report #354967
HPV (GARDASIL) vaccine side effect was reported on 08/21/2009. Female patient, 18.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Fatigue, "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." nonenone. Chronic lower back pain. Seasonal allergies. Bilateral shoulder dystocia as a child. Wisdom tooth extraction. Migraine and tension headaches."Positive ANA, Postitive EEG. LABS and DIAGNOSTICS: Lumbar Puncture - Normal. MRI Head and Spine - Normal. Somatosensory Evoked Potentials - Abnormal. Visual Evoked Potentials - Abnormal. ANA (+). Sleep Study - Abnormal. MRI Back - heman" . Patient recovered.

HPV (GARDASIL) Side Effects Report #354969
HPV (GARDASIL) vaccine side effect was reported on 08/20/2009. Female patient, 17.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Fatigue, "From the time of vaccination until about a month after, I experienced moderate pain in my left arm at the injection site and in the entire arm and had pain when trying to move it. By that time, school had started on Sept 26, and over the course of the next few months and to the present I began to (and still) experience weakness, dizziness, and fatigue, sometimes with episodes of confusion or disorientation. No matter how much rest or sleep I get, I still experience those symptoms. Also during this same time period, I began to get chronic headaches that varied in severity and struck suddenly during everyday activities. I know for a fact that the headaches were neither due to dehydration or heat stroke because I drink 2 liters of water daily and it was the winter season. In late 2008, around early December, I began to notice something off in my vision. It seemed that when I looked at straight lines, like edges of a wall or a doorframe, etc, the surfaces seemed to shake. All of my symptoms persisted into the new year and the dizziness and vision problem worsened. During January 2009, I started to become so dizzy that it began to affect my balance. I would start stumbling or have errors in depth perception and walk into walls or other solid objects. The vision problem, after doing some online research, I believe is a condition called nystagmus, started to affect not just straight-line figures in my vision, but all shapes and figures. Soon I was seeing my entire environment seem like it was all vibrating or oscillating from side to side or up and down very rapidly. These symptoms, along with the dizziness continued up until February 27, 2009. On the morning of Feb 27, at 8:00a I had just woken up and started to brush my teeth when blood started streaming out of my nose. I hadn't irritated my nose by blowing it or picking it and my nose wasn't too dry either. It was a completely random occurrence. It just started bleeding and it wouldn't stop. Within five minutes' time so much blood had flowed out that it was all over" Moderate pain at injection site"Asthma, seasonal allergies. 9/1/09 ER records received DOS 3/5/09. Allergy to Augmentin. Asthma.""Upon arriving at the ER at Medical Center, prior to seeing the doctor, the nurse took my vitals and noticed that one of my pupils were slightly dilated. I saw the doctor and he ordered labs and brain scans. After a CT, lumbar puncture, and" . Patient recovered.

HPV (GARDASIL) Side Effects Report #355009
HPV (GARDASIL) vaccine side effect was reported on 08/18/2009. Female patient, 14.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Fatigue, "Diagnosed with Type 1 Diabetes Mellitus 10 days after receiving 3rd dose of GARDASIL vaccine made by Merck. 8/25/09 PCP records rec'd. WCC with no concerns 6/3/08-healthy. HPV#1 given. Returned 12/30/08 with c/o fatigue x several weeks, eating and drinking more than usual and rapid wt loss. Urine (+) for ketones at home. Assessment: Diabetes mellitus. Labs: Urinalysis (+) for protein 30, trace blood, large ketones (160). glucose 1000. BS 358. 9/3/09 Hospital records received DOS 12/30/08 to 1/1/09. Assessment: Diabetes mellitus new onset, Diabetic ketoacidosis. Presented with recent weight loss, increased thirst, increased urination, increased hunger. Generalized weakness, fatigue, headache, fever. Episode of vomiting. Constipation. Decreased muscle bulk." NoneNone12/30/09 Lab glucose 348; Sodium 136; Potassium 3.5; Chloride 103; CO2 9; Urea Nitrogens 14; Creatinine 1.0. 9/3/09 Hospital records received DOS 12/30/08 to 1/1/09. LABS and DIAGNOSTICS: Home Urine Test - Ketones. Fingerstick blood sugar - . Patient was hospitalized Patient recovered.

HPV (GARDASIL) Side Effects Report #355058
HPV (GARDASIL) vaccine side effect was reported on 08/24/2009. Female patient, 13.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Fatigue, "Mother reports fatigue and complaints of chest pain, abdominal pain." nononeEKG and Chest X-ray within normal limit results . Patient recovered.

HPV (GARDASIL) Side Effects Report #355073
HPV (GARDASIL) vaccine side effect was reported on 08/24/2009. Female patient, child 11.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Fatigue, "Long-term chronic nausea, chronic abdominal pain, face rash, anxiety, fatigue, depression, weight loss, loss of appetite, tremors, foaming of mouth...required visits to 3 different doctors with numerous prescription medications ordered with no relief. Additional medical records received 10/8/09 Dates of Service 8/4/08 to 9/2/09. Assessment: Contact pruritus, dermatitis, cellulitis, local infection, pyelonephritis, UTI, Influenza with other respiratory manifestations. Assessment: Presented on 8/4/08 with small red lesions on the left inner buttocks, diagnosed with pruritus, contact dermatitis and cellulitis. On 11/15/08 presented with rash and itching of right inner buttocks; diagnosed with cellulitis and a local infection. 6/17/09, presented with fever, lethargy, chills, lower abdominal pressure, and increased urination; diagnosed with pyelonephritis. Follow up on 6/19/09 c/o nightsweats, right lower quadrant abdominal tenderness; diagnosed with UTI. Seen on 9/2/09 for cough, rhinitis, pharyngitis, fever, diarrhea, body aches and chills; diagnosed with influenza with other respiratory manifestations. Presecibed Tamuflu." napenicillin"urine tests(2x); full blood work (2x), upper/lower GI; stool cultures (2x); CT scan Urinalysis: PH 5.0 (L), Blood 1+ (H), Ketones 1+ (H), Protein trace (6/17/09). WBC 15.4 (H), granulocytes 90.8 (H), Anion Gap 16 (H). UA on 6/19/09: Ke" . During the same period patient was treated with na. Patient was hospitalized Patient recovered.

HPV (GARDASIL) Side Effects Report #355112
HPV (GARDASIL) vaccine side effect was reported on 08/12/2009. Female patient, child 12.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Fatigue, "Rash on legs. One leg shape of a triangle. Having HA's and abdominal cramping, fatigue." None1-7-08- Allergic / 12-13-05 allergic Rhinitis . During the same period patient was treated with None. Patient recovered.

HPV (GARDASIL) Side Effects Report #355229
HPV (GARDASIL) vaccine side effect was reported on 08/25/2009. Female patient, 15.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Fatigue, "Severe Gastritis, weakness, wt. loss.Nausea, vomitting ,diarreha, anal spasms, vagal reflex responses, & paleness. 9/17/09 GI Consult records DOS 10/4/07 to 6/12/09 Assessment: Reflux Esophagitis. Eosinophilia. Patient presents with abdominal pain followed by diarrhea. Loose, watery bowel movements. Cramping, weight loss, burping, anxiety, sore throat, fatigue, reflux esophagitis. 10/12/09 ICD9 codes received for date of service 6/25/09: 789.09, 535.10, 787.91" none"8/31/09 PCP Note DOS 2/9/07. Fever, nausea. Cough. Oropharynx erythematous. Flu-like illness. WBC count 3.5 (L).""Endoscopy,colonoscopy, multiple stool specimens, blood tests ,Ct scans,& x-rays. LABS and DIAGNOSTICS: Endoscopy EGD with biopsies, colonoscopy with biopsies - abnormal. CBC - HGB 15.4 g/dL (H) Eosin 24% (H) Eosin 2.1 x10E3/uL. UIBC 140 u" . During the same period patient was treated with none. Patient was hospitalized Patient recovered.

HPV (GARDASIL) Side Effects Report #355254
HPV (GARDASIL) vaccine side effect was reported on 08/25/2009. Female patient, 15.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Fatigue, "As per patient - 2hrs after vaccines - developed numbness in arms, hands, felt lightheaded and heart rate speeding. Rescue was called and taken to ER. Few days later (4) Pt confirmed with ~problems~ and was hospitalized x 48 hours. 9/9/09-ICD-9 codes received 780.4. 785.1. 780.97. 9/9/09-ED report received presented om 8/11/09 with C/O feeling tired and dizzy, improving upon arrival to ED. Observed by parent to have tremors and when assessed without parent present, completely normal. Clinical impression acute dizziness. Palpitations. Altered mental status. Histeria." In ER and Hospital. 9/9/09-records received-CT normal. . During the same period patient was treated with PPD. Patient recovered.

HPV (GARDASIL) Side Effects Report #355418
HPV (GARDASIL) vaccine side effect was reported on 08/25/2009. Female patient, 17.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Fatigue, "Information has been received from a physician concerning a 17 year old female patient who on 05-AUG-2009 was vaccinated intramuscular with the first and only dose of 0.5ml GARDASIL (lot # 663452/0671Y). Secondary suspected therapy included VARIVAX administered on 05-UG-2009. Other concomitant therapy included ADVAIR and MENACTRA administered on 05-AUG-2009. On 06-AUG-2009 the patient developed exertional vertigo and extreme fatigue. The patient was a Division 1 softball player and she had not been able to participate due to these symptoms. On 18-AUG-2009 the patient had syncope and ended up in the emergency room. she was not admitted. She will be seen in the office on 19-AUG-2009. The patient had sought the physician for medical attention on 11-AUG-2009. The patient had not recovered. The patient's exertional vertigo, extreme fatigue and syncope were considered to be disabling. Follow up information has been received from the physician concerning the 17 year old female patient who on 15-AUG-2009 had concomitantly received the second dose of VARIVAX (LOT# 664701/0726Y) and MENACTRA (LOT # U291944). On 18-AUG-2009, the patient had syncope and was taken to the Emergency room. The patient had a CT scan and laboratory tests. All testing was negative. The patient was not admitted to the hospital. The patient was seen by the physician on 19-aug-2009. The patient complained of nausea, dizzy and light-headedness on exertion. The physician stated that he was going to refer the patient to a cardiologist for evaluation. Additional information has been requested. 9/3/09 Received ER medical records of 8/18-8/19/2009. FINAL DX: dizziness w/evidence of mild heat exhaustion; possible HPV vaccine side effects. Remained stable & d/c to home w/PCP f/u. Records reveal patient experienced dizziness & malaise since vaccines, with nausea & vomiting while playing sports on day of admission. 9/8/09 Received PCP record of 8/19/09 & vaccine records. FINAL DX: syncopy & nausea Records reveal seen in ER w/neg w/u. Recovered. 11/" None 9/3/09 Medical records received w/PMH: right knee surgery. 11/5/09 Medical records received for date 9/18/09 and 10/15/09 PMH: several syncopal episodes till age 8."computed axial, 08/18/09, negative; laboratory test, 08/18/09, negative 9/3/09 Medical records received w/LABS: CBC, CMP, CT brain WNL. 11/5/09 Medical records received for date 9/18/09 and 10/15/09 Diagnostics: MRI brain(-), EEG(-), bl" . During the same period patient was treated with ADVAIR. Patient recovered.

HPV (GARDASIL) Side Effects Report #355482
HPV (GARDASIL) vaccine side effect was reported on 08/26/2009. Female patient, 16.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Fatigue, "Initial near syncopal episode at time of vaccination on 7/30/09. Approximatley 8/11/09, she began to have intermittent problems with easy bruising, tingling, 9/25/09 Received PCP medical records which reveal patient in good general health on day of vaccination & had brief vasovagal syncope after shot. RTC 8/28 after symptoms began 8/11/09 of malaise, tiredness, easy bruising & near fainting episodes while driving. Exam revealed shotty cervical lymph nodes, erythematous throat, macular bruising on arms & nodule on right shin. 9/11 labs revealed + strep & had recent tick bite. Tx w/oral antibiotics." NoneHistory of pyelonephritis 9/25/09 Medical records received w/PMH: pyelonephritis. Allergy: amoxicillin.cbc - WNL; glu 85; ekg: sinus bradycardia; other labs pending 9/25/09 Medical records received w/LABS: (+)ASO . Patient recovered.

HPV (GARDASIL) Side Effects Report #355483
HPV (GARDASIL) vaccine side effect was reported on 08/26/2009. Female patient, 14.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Fatigue, "Severe headaches/migraines which cause sleeplessness, stomache aches, painful menstrual periods, nausea, always tired and feels like sleeping all the time, dizziness, heartburn. Unable to eat certain foods like fast food burgers. Had appendix taken out October 31, 2008 after one week of fevers above 103 for one week and emergency room visits. Finally after one week surgeon looked at records and determined appendix should have been removed one week earlier. 9/29/09 PCP records received DOS 1/5/07 to 8/7/09. Assessment: Transferred migraine, rebound analgesic headache, anxiety. Patient c/o recent headaches. Repeated strep pharyngitis. Plan B emergency contraception. Oral contraception initiated. Flat affect. Anxiety. Pelvic inflammatory disease. Headaches with photophobia and phonophobia. Pharyngitis/laryngitis with productive cough and wheezing. Bronchitis. Dry eczematous rash skin arms and legs. Abdominal pain, diarrhea, constipation. Gastroenteritis. Depo-Provera initiated. Muscle tension headaches. Insomnia. Painful intercourse. 9/29/09 Hospital records received DOS ER 10/25/08 Inpatient 10/31/08. Assessment: Appendicitis. Patient presented with right lower quandrant abdominal pain. Hematuria. Nauseous, vomited. Discharged from ER. Presents several days later with same complaints. Laparoscopic appendectomy. Pelvic inflammation. ICD-9 Codes: 540.9 Acute Appendicitis NOS, 784.0 Headache, 305.1 Tobacco use disorder/depend." none. 9/29/09 PCP records received DOS 1/5/07 to 8/7/09. Depression. Allergic rhinitis. Acne."allergic to cats. 9/29/09 PCP records received DOS 1/5/07 to 8/7/09. Strep Pharyngitis with fever, nausea and vomiting."9/29/09 PCP records received DOS 1/5/07 to 8/7/09. LABS and DIAGNOSTICS: Rapid Strep Test (+). CBC - WBC 13.0 Thous 10*3/ul(H) MPV 7.3 cu mic (L) Grans 81.1% (H) Lymphs 11.2% (L) ABS Gran 10.6 Thous (H). 9/29/09 Hospital records received . During the same period patient was treated with Doxycycline. Patient was hospitalized Patient recovered.

HPV (GARDASIL) Side Effects Report #355894
HPV (GARDASIL) vaccine side effect was reported on 08/29/2009. Female patient, 15.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Fatigue, "fatigue, fainting, dizziness and seizures starting in 10/08 and lasting until seizure were under control in 3/09 while taking trileptal. There were a few fainting spells and over twenty different seizures during the five month period. Seizures started again after second dose of gardasil given in 6/09. 9/15/09 Neurology consult records received DOS 6/10/09. Assessment: Complex partial epilepsy. Patient had episode of loss of consciousness. Passed out 7-8 min w/o postictal period. Recurrent episode with whole body jerking following by 30 min postictal period. Continued recurrent seizures. Episodes are preceeded by chest pain." 9/15/09 Neurology consult records received DOS 6/10/09. Trauma (L) elbow with surgical fixation.9/15/09 Neurology consult records received DOS 6/10/09. LABS and DIAGNOSTICS: EEG - ABNORMAL. MRI - Normal. Echocardiogram - Unremarkable. Chest X-ray - Unremarkable. EKG - Unremarkable. . Patient recovered.

HPV (GARDASIL) Side Effects Report #356081
HPV (GARDASIL) vaccine side effect was reported on 08/31/2009. Female patient, 15.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Fatigue, "After receiving vaccine daughter c/o pain to injection site for days. c/o headache, dizziness, ~stomache ache~, fatigue and general malaise. Intermittent numbness to hand/ wrist, joint and bone pain. On August 18, patient woke with swelling to finger, collapsed 15 minutes later with syncopal episode and vomiting with ~seizure like activity~. Pt transported to ER. Patient developed swelling to hands and feet with scattered rash. Discharged with prednisone and benedryl. Continued to c/o joint pain and fatigue with dizziness. August 24, while in school, severe dizziness, tremors with ~seizure like activity~, memory loss. Transient numbness to extremities. Transported to another ER and currently awaiting EEG and neurology appointment. 9/9/09 PCP medical records received DOS 8/25/08 to 8/31/09. Assessment: Medication Rxn to vaccine. Syncope. Presented at ER with edema, SOB, syncope, slow speech, confused. Ref to neurologist. 10/23/09: EEG Report received for date of service 9/15/09. Assessment: Normal awake and asleep EEG for a 15 year-old 10/23/09: EEG Report received for date of service 9/15/09. Assessment: Normal awake and asleep EEG for a 15 year-old. 10/26/09 Medical records received for date 9/21/09 Neurology consultation. Presented with c/o acute encephalopathic episodes x2 one month ago and episodes of hand, foot swelling with shoot neuropathic pains in her legs and arms. Confusion, lightheadedness, syncope, joint pains, back pain, numbness in toes/hands. Pt had gardasil one month prior to episodes. Assessment: WNL except bilateral atrophy of intrinsic hand muscles.DX: no evidence of seizure will order labs." none"asthma, acne. 9/9/09 PCP medical records received DOS 8/25/08 to 8/31/09. Asthma, allergies. Chronic folliculitis.""CT scan, EKG, lumbar puncture, chest xray, CBC, CMP, sed rate, drug screen, UA. 10/23/09: EEG Report received for date of service 9/15/09. Assessment: Normal awake and asleep EEG for a 15 year-old. 10/26/09 Medical records received fo" . During the same period patient was treated with "Yaz, Minocycline, (albuterol, advair, flonase precscribed but not being used at time of reaction)". Patient recovered.

HPV (GARDASIL) Side Effects Report #356102
HPV (GARDASIL) vaccine side effect was reported on 08/25/2009. Female patient, 16.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Fatigue, "Per pts. mother, pt. started experiencing extreme fatigue/weakness and some nausea in morning on 08/21/2009. Pt. was taken to PCP and Hgb check was done as pt. also started menses on 08/21/2009. Pt. felt fine all weekend and then on 8/25/09 started with headache, chills, nausea, and weakness, and was again taken to PCP and was at this time tested for influenza. Per mom, PCP is unsure of course of symptoms." None"Allergic to sulfa, KEFLEX, DURICEF"Hemoglobin performed on 8/21/09 - normal result per pts. mom. Influenza test - result pending. . During the same period patient was treated with None. Patient recovered.

HPV (GARDASIL) Side Effects Report #356226
HPV (GARDASIL) vaccine side effect was reported on 08/27/2009. Female patient, 17.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Fatigue, "Near syncope - some chest pain & dizziness nausea. 2nd episode 19th/8/09 (same SX). 9/3/09-records recived-date of service 8/25/09-2 episodes of basically near syncope, chest pain and nausea associated with it-dizziness and lightheadedness. First occurred on 8/19/09. Heart beat felt rapid. Second episode on same day. General sense of fatigue which is longstanding.C/O back pain in office day vaccines administered." NoNo 9/3/09-records received- Mom has history of panic attacks. . Patient recovered.

HPV (GARDASIL) Side Effects Report #356304
HPV (GARDASIL) vaccine side effect was reported on 09/01/2009. Female patient, child 12.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Fatigue, "Information has been received from a physician and an office manager concerning a 12 year old female patient with amoxicillin allergy (AMOXILIN) who on 26-AUG-2009 was vaccinated with the first 0.5 ml of a dose of GARDASIL, concomitantly with a dose of BOOSTRIX (Lot: AC528046AA), a dose of VARIVAX (Lot: 664232/0498Y) and a dose of MENACTRA (Lot: U2815AA). The patient stated that after the vaccinations she felt tired. She went home and had a seizure. The patient went to Emergency room and had computed axial tomography (CAT) done (results not reported). The patient was not hospitalized. The patient's mother called on 27-AUG-2009 at the Physician's office and stated that her daughter was doing better. The physician also stated that he did not consider the events to be Life threatening or to have caused the patient significant Disability or Incapacity. Upon internal review seizure was considered as other important medical event. Additional information has been requested. 9/21/09 ER records received for DOS 8/26/09 with dx: possible seizure by hx with normal exam in ER. Pt presented after episode of staring, becoming stiff, shaking and jerking, eyes rolling back in head and lack of memory of event. Confused after." Penicillin allergyPMH: allergy to Amoxicillin/"computed axial, 08/26/09 Labs and diagnostics: CT brain WNL. CBC/CMP WNL. drug screen (-). EEG abnormal. EKG NSR. BS 104." . During the same period patient was treated with Unknown. Patient recovered.

HPV (GARDASIL) Side Effects Report #356328
HPV (GARDASIL) vaccine side effect was reported on 08/25/2009. Female patient, 17.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Fatigue, "Bradycardia, arrythmias, heart block, syncope, chest pains. Taking 3 kinds of medicine daily. Has plenty of follow ups with cardiologists, possibly put in a pacemaker. 9/25/09 ER records reeived DOS 11/10/08 and 11/22/08. Assessment: syncopal episodes, sinusitis, sinus arrhythmia. Patient felt dizzy, passed out, hit side of head. Presents at ER awake and alert saying she feels tired. Lost 40 lbs during the past year. Irregular periods. Nose stuffy. Drowsy. Bump on side of head. Systolic murmur left sternal border. 11/2/2009 records from 6/4-6/7/2009 and ED visit 8/5/2009. Patient was seen for c/o's syncope on both occasions. Tx: telemetry, lab and echo normal, Ekg noted bradycardia. Patient discharged with Holter monitor. Dx: vasovagal syncope" NoNone. Caffeine beverages. PMH: none Allergies: NKDA"EKG; Echocardiogram; Tilt table test; EEG; Bloodwork. LABS and DIAGNOSTICS: EKG - Abnormal, sinus bradycardia with A-V dissociation and junctional rhythm. Chest X-ray - Minimal scoliosis, otherwise normal. CT Head - Sphenoid sinusitis, oth" . During the same period patient was treated with None. Patient was hospitalized Patient recovered.

HPV (GARDASIL) Side Effects Report #356573
HPV (GARDASIL) vaccine side effect was reported on 09/04/2009. Female patient, child 12.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Fatigue, "Gardasil #1, Hep A #1, Menactra and flu given 10/5/07. Patient seen 5/12/08 and reported vomiting several times a week since thanksgiving (about 6-7 weeks after vaccine), limb pain, parasthesia's, headaches and fatigue. Patient still nearly 2 years later with vomiting several times a week, leg pain and tremors in her right hand/arm bad enough to interfere with school work and writing. She has had extensive GI and neuro evaluation with no diagnosis and no satisfactory treatment of symptoms. We do not know if this is related to gardasil but have begun to question it. She had a second gardasil 7/21/08. Of note, this patient has a sister with a severe mitochondrial disorder affecting her gut function, seizures, deteriorating mental function. 9/14/09 MR received from pcp which include multi-specialty consults dated from 10/2007 to 9/2009. In for WCC 10/5/07 with dx: Well. 4 vax given. Multiple visits after for pharyngitis, URI, tinea corporis, vomiting x 6 months with 8 lb weight loss, H/A, blurry vision, lower limb pain, decreased sleep, strep throat. Dx: Migraine/vomiting weight loss. Referred for labs and consults. By 9/3/09 reporting continued vomiting, tremors, muscle pain. GI consult with no specific dx made. 6/16/09 reports worsening of sx. PE (+) for fine tremor of tongue and hands. Neuro consult 6/29/09 with impression: Migraine complex. Returned for w/u for possible seizures due to episodes or tremors and jerking of the R side." wellmenorrhagia. PMH: Menorrhagia. ankle pain."carnitine level low, scope nl, fasting blood sugar, b12, folate, heavy metal screen, sleep study, ekg all nl as far as I know. EEG abnl--getting further studies. Labs and diagnostics: MRI head (-). Upper GI with small bowel WNL. EGD WNL" . During the same period patient was treated with "micronor at time of vaccination. Now on lo ovral, ponstel, zofran, carafate, lactaid, prilosec, amitryptyline". Patient recovered.

HPV (GARDASIL) Side Effects Report #356630
HPV (GARDASIL) vaccine side effect was reported on 09/04/2009. Female patient, 17.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Fatigue, "10:05A - received vaccines shortly after got nauseated, warm. Dizzy - laid in supine position. Ice to back of neck. BP (L) arm sitting 104/60 pulse 60 slightly thready. Skin warm & dry palms sweaty/clammy. After 15-20 min c/o trouble getting breath, tongue feeling funny, general feeling ~feeling funny~, unable to describe. Mid chest became red in color - lacy looking at this time. Client c/o again of not being able to get breath, speech somewhat slurry & thick sounding - E vehicle called. B/P 106/68 Pulse continues to be slightly thready but 60-60 in number. Feeder were evaluated. Skin dry, palms of hands sweaty. Rash after approx 5 min decreased in intensity. Continues to c/o of feeling weird, but unable to describe feelings. Throughout this event client continued to have ~spasms of legs, arms & lips - denied being cold. Transported by E-vehicle to hospital. 9-4-09 9AM TC to parent. Patient is tired, but has been taking BENADRYL. No rash at this time. Eating & drinking. Slept most of yesterday. Taking ibuprofen also for c/o HA & sore arm." NoneNoneE Room gave IV BENADRYL - no rash present . During the same period patient was treated with BCP. Patient recovered.

HPV (GARDASIL) Side Effects Report #356463
HPV (GARDASIL) vaccine side effect was reported on 09/03/2009. Female patient, 17.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Fatigue, "Had seizure approx 1 month after having the 2nd hpv vaccine. since then have been suffering from dizziness, sometimes sore achy left arm. Weakness, fatigue, sensitivity to light, headaches. MRI done and came back clear with ~no cause for seizure~ seeing Neurologist next week for EEG. Been to doctor and had three sets of blood tests done with no findings. Have had my eyes tested and they came back fine." Cold during first vaccine - felt fine for 2nd.asthma. . During the same period patient was treated with monofeme (oral contraceptive)ventolin inhaler (asthma). Patient recovered.

HPV (GARDASIL) Side Effects Report #356699
HPV (GARDASIL) vaccine side effect was reported on 09/08/2009. Female patient, 13.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Fatigue, "9-3-09 Rec'd T/C from MGM, advised client developed enlarged node Left side of her neck,close to the clavicle on 8-21-09. States client has been very tired but has been going to school. MGM stated client did not have any fever, sore throat or headache. PHN advised MGM to take client to Urgent Care, as she does not have a PCP." "9-8-09 T/C to parent, states she has not taken client to Urgent care due to cost. State she doesn't have a PCP, doesn't qualify for assistance, state there is no Free Clinic. PHN strongly enc. parent to have client seen by a physician. Gave" . Patient recovered.

HPV (GARDASIL) Side Effects Report #356835
HPV (GARDASIL) vaccine side effect was reported on 09/09/2009. Female patient, 15.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Fatigue, "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." None"Short Stature 9/28/09 Medical records and DC summary received from date of service 11/1/08 to 11/7/08 PMH: anemia, menstral irregularities with heavy flow, short stature with growth hormone treatment, Oral contraceptives.""CBC's.Coobs test. Bone marrow aspirate and BM biopsy. ANA. Retic count. LDH. Complements. Chest x ray. Serologies for Parvo, CMV, HIV, MONO. Iron studies and Chromosome analysis. 9/28/09 Medical records and DC summary received from date of" . During the same period patient was treated with None. At the time of vaccination. Treated with Growth Hormone from age 10-13. Patient was hospitalized Patient recovered.

HPV (GARDASIL) Side Effects Report #356846
HPV (GARDASIL) vaccine side effect was reported on 09/08/2009. Female patient, 13.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Fatigue, "Diagnosed w/ juvenile rheumatoid arthritis 1/09. Symptoms have been progressive since 2007. Also has asthma, scoliosis and migraine HA. 9/25/09 Medical records/ER visits received DOS 3/11/02 to 06/20/08. Patient presents with infection behind (R) leg. Fatigue. 9/27/09 Medical records received DOS 8/22/08 to 9/5/09. Assessment: Juvenile Idiopathic Arthritis of Polyarticular Subtype / Arthritis Secondary to Bowel Disease. Finger pain and swelling. Loose stools, achiness, knees weak. Generalized pain. Morning pain, stiffness in back, toes, fingers. Shoulder pain. Stomach pain after eating. Nose sore, anxious and sad. Sacroiliac joint pain. Decrease in lumbar flexion. Sinusitis. Viral illness. Lips swelled." Asthma; Scoliosis; Migraine HA"Pistachio; reaction to valium. Received 2 doses Hep A vaccine recalled for poss lack of potency. Scoliosis, back pain. Scoliosis brace. Thigh, calf pain. Numbness tingling right foot, insomnia. Sacroiliac joint syndrome. Adverse reaction to Valium. Eye rolling and facial twitching. Myoclonic jerking, anxiety, hallucinations, headaches. Panic attacks. Asthma. Vertigo. Injured should"LABS and DIAGNOSTICS: Rheumatoid Factor 28 (+). Anti-Saccharomyces Cerevisiae Antibody (ASCA) (+). X-ray Hand - Abnormal. PPD (-). CHEM - Glucose 60 mg/dL (L). . Patient recovered.

HPV (GARDASIL) Side Effects Report #356914
HPV (GARDASIL) vaccine side effect was reported . Female patient, 15.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Fatigue, "Diffuse myalgias, fatigue, nausea, sweating for approximately 36 hours, with onset approx. 5-10 hours after receiving vaccines. Rash developed 8/17/09." NoneNone . During the same period patient was treated with None. Patient recovered.

HPV (GARDASIL) Side Effects Report #356938
HPV (GARDASIL) vaccine side effect was reported on 09/10/2009. Female patient, 19.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Fatigue, "Headache, Nausea, dizziness, chilling, tiredness, shortness of breath, complained of chest plain, severe cramps. 9/14/09 Received vaccine & PCP medical records which reveal patient seen 12/5/07 & 2/27/08 with sore throat, fever, chills, fatigue, body aches, productive cough w/yellow sputum & HA. Dx both times w/acute bronchitis & tx w/antibiotics & cough syrup. 9/25/09 Autopsy report received DOD 09/12/2008. Acute Cardiac Arrhythmia of Unknown Etiology. Addtional information abstracted: Heart with focal microscopic ischemic changes, pulmonary congestion and edema. Rare petechiae: conjunctival, periorbital and laryngeal. Resuscitation related sternal fracture." NoneNoneNone. I do have copies of all medical history from 01/08/2004 to the time of her death that I can provide if needed. The Medical Examiners office will have tissue samples until 4/2010. . During the same period patient was treated with Yaz until 3/17/08. Femcon beginning 3/17/08. Anaprox as needed.. Patient died on 2//08/09/1.

HPV (GARDASIL) Side Effects Report #356939
HPV (GARDASIL) vaccine side effect was reported on 09/10/2009. Female patient, 17.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Fatigue, "Mental status changes starting 7 days after immunization with fever, headache, lethargy, inability to walk, discoordination, signs of autonomic instability (BP/pulse). Two events of brief seizure with mouth pulling to the left separated by 30 minutes occurring on one day about 1 month following onset of symptoms. Fatigue, intermittent tachycardia, left-sided headache and general weakness have persisted, although improved over the past 3 months. She has diffuse, symmetric hyperreflexia in all extremities with 1-beat clonus of the right ankle. Diagnosis of ADEM was made. No treatment given. 12/23/2009 Clinic note received for DOS 11/18/2009. DX: Post Vaccine ADEEM Patient presented complaint of tachycardia lasting 3 to 4 days, pain in leg, episode of right hand shaking for a few minutes, episode of rapid trembling, shortness of breath and increased headache and fatigue. Assessment: No evidence of recurrence of demyelinating lesion, re-current symptoms are residual from first attack. 12/23/2009 Neurology consult, clinic note and MRI report received for DOS 07/14/2009-11/18/2009. DX: ADEM One week after receiving Gardasil vaccine, patient developed high fever, tachycardia and unsteady gait. Patient was hospitalized (2 days) for headache and tachycardia and was treated with antibiotics. Due to persistent fatigue, patient was re-admitted and diagnostic tests were performed. All symptoms improved. Patient still has fatigue and notes twitching on arms, legs and face. Gait has returned to normal. 01/06/2010 Hospital H&P, consults and diagnostic tests received for DOS 07/13/09- 07/14/09 and laboratory tests received for DOS 06/05/09. DX: Lethargy, Headache, Weakness. Poss. Acute Demyelinating Encephalomyelitis. Patient c/o increasing weakness, pressure in the head when moving, passed out two days earlier, headach. Neurologic examinaton noted hyperreflexia with sustained clonus." None"12/23/2009 PMH: Eczema, Allergy to PanMist DM Syrp. PMH: pneumonia, chronic sinusitis, chicken pox.""MRI of head and spine +/- contrast with small areas of intensity. LP with CSF normal, including evaluation for oligoclonal bands negative. 12/23/2009 Diagnostics: WBC-Elevated, Blood cultures-Negative, Lumbar puncture-Negative, MRI of c" . Patient was hospitalized Patient recovered.

HPV (GARDASIL) Side Effects Report #356950
HPV (GARDASIL) vaccine side effect was reported on 09/10/2009. Female patient, 18.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Fatigue, "Symptoms began with hair loss two months after first shot, progressed to stomach problems, indigestion, bloating, menstrual irregularities, PMS Symtoms very bad, yeast infection, bladder infection, extreme fatigue, extreme headaches, muscle aches, foggy vision, foggy memory, inability to concentrate, depression, anxiety. We are currently treating her for Systemic Candidias. 9/18/09 PCP medical records received DOS 10/2/06 to 6/27/08. Assessment: Cystitis. Irritable bowel syndrome alternating type. GERD. Patient presents with urinary urgency, dysuria, and frequency. Hypogastric tenderness. Nevus on shoulder. Dysplastic Nevus. Multiple benign nevi. Sinus infection, stomach ache, constipation, feeling run down, sore throat. UTI. Diarrhea. Ankle injury. Bloating. Dizziness, 'spacy', hair loss. Mucous in stool. Pelvic pain. LGSIL. Abnormal bowel movement pattern. Inflammation of colon." None. 9/18/09 PCP medical records received DOS 10/2/06 to 6/27/08. MetrorrhagiaNone. 9/18/09 PCP medical records received DOS 10/2/06 to 6/27/08. Septal rhinoplasty with tonsillectomy.Doctors performed many tests and we came back with no answers. Other than positive results for numerous yeast infections and bladder infections. 9/18/09 PCP medical records received DOS 10/2/06 to 6/27/08. LABS and DIAGNOSTICS: Urinalysi . During the same period patient was treated with None. 9/18/09 PCP medical records received DOS 10/2/06 to 6/27/08. Ortho Tri-Cyclen. Patient recovered.

HPV (GARDASIL) Side Effects Report #356991
HPV (GARDASIL) vaccine side effect was reported on 09/11/2009. Female patient, 16.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Fatigue, "patient recieved Gardasil on 12/19/07, second dose on 2/20/08, and last dose on 6/23/2008. Extremely tired and at times seemed slow to respond.On 6/24/2009, went to family doctor to get menactra for college admission. That night patient had seizure during sleep. Bit tongue severely and had memory loss.Went to doctor, told to watch and wait. On 9/1/2009, patient suffered grand mal seizure at college and was taken to emergency room and evaluated. Sent to see neurologist next day and put on lamictal to control seizures. Following up on Sept 18 2009 with EEG and MRI.No family history at all of seizures and has been diagnosed with sudden onset seizures. 9/15/09 PCP and Neurology consult records received DOS 6/26/09 to 9/2/09. Assessment: Seizure disorder. Patient c/o 'feeling really weird', woke up with discoloration and swelling left side of tongue. Trouble recalling things, took longer to remember things. Felt hot. Tongue bitten. Second seizure. Stiffening, jerking. Collapsed to floor. Taken to ER. Neurological exam WNL. 9/15/09 PCP and Neurology consult records received DOS 6/26/09 to 9/2/09. Assessment: Seizure disorder. Patient c/o 'feeling really weird', woke up with discoloration and swelling left side of tongue. Trouble recalling things, took longer to remember things. Felt hot. Tongue bitten. Second seizure. Stiffening, jerking. Collapsed to floor. Taken to ER. Neurological exam WNL. 9/24/09 ER records received DOS 9/1/09. Assessment: New onset seizure. Seizure occuring just prior to arrival. Head injuries. Post-ictal headache and mild confusion. Sinusitis." "none, healthy""none 9/15/09 Received medical records w/Menactra, Lot #U2670AA, given LA on 6/24/2009."Still doing tests. Will have mri and eeg. LABS and DIAGNOSTICS: Cranial CAT Scan Unremarkable. Cervical Spine CAT Scan Unremarkable. Blood Studies Unremarkable. 9/24/09 ER records received DOS 9/1/09. LABS and DIAGNOSTICS: Normal EKG . Patient recovered.

HPV (GARDASIL) Side Effects Report #357068
HPV (GARDASIL) vaccine side effect was reported on 09/12/2009. Female patient, 21.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Fatigue, "Had dizziness after first shot on 5/11/2009. My daughter had mild dizziness and headaches on and off after shot but the first week of July she had severe dizziness and nausea. Taken to emergency room for treatment. Treated with antibiotic and antivert. 10 days after this visit, taken back to emergency room with 103 degree temp, severe abdominal pain, dizziness, nausea and vomiting. Also had asthma attack that required rescue inhaler. Had not had asthma attack for over 10 years. Treated at ER with IV fluids, IV antibiotics, IV pain medications and IV antiemetics. CT of abdomen showed infection of the colon. Sent home on Flagyl, Cipro, Lortab and Phenergan. Had some blood in stool and rectal pain for 3 weeks after this visit. Continues to have dizziness, nausea and left upper quadrant abdominal pain. Has bleeding between periods and fatigue. Prior to the Gardisil shot, my daughter was healthy and had not been in emergency room for over 5 years. She was scheduled for her second shot on 7/13/2009 and we did not get it. 11/3/2009 records from ED visits 7/2 and 7/11/2009.Dc Dx Vertigo, abdominal pain, Colitis Patient presented on 7/2/2009 with c/o's vertigo and dizziness. Tx'd with antivert, medrol dose pak. On 7/11/2009 patient presented with c/o's nausea, vomiting, fever and LUQ abd pain. Tx: IVF, IV ABX, IV Zofran and Dilaudid." None"Allergies: Metal (dermatitis), antihistamine/decongestant combinations, Medical:S/P perthes L hip, asthma (controlled),seasonal allergies PMH: Asthma Allergies: antihistamine/decongestant mix""Labs 7/11 CBC, WBC 17.0 high, Chem profile Low Na, high glucose, Urine pregnancy test neg Dx tests: Ct Abd/Pelvis noted ? inflammatory colitis" . Patient recovered.

HPV (GARDASIL) Side Effects Report #357357
HPV (GARDASIL) vaccine side effect was reported on 09/15/2009. Female patient, 18.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Fatigue, "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." none"10/26/09: Outpatient medical records received for dates of service 2/6/08 to 10/5/09. PMH: Eye surgery for esophoria, wisdom teeth removal, Allergic to Amoxicillin.""Vaccine dates: Feb 27/07, Apr 27/07, Sept 07/07 10/26/09: Outpatient medical records received for dates of service 2/6/08 to 10/5/09. Labs and diagnostics: ANA-Positive, anti-CCP ab.-Positive, anti RNP ab.-Positive, CRP-Negative, Lupus" . Patient recovered.

HPV (GARDASIL) Side Effects Report #357372
HPV (GARDASIL) vaccine side effect was reported on 09/15/2009. Female patient, 15.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Fatigue, "within 20 minutes of shot, became dizzy with nausea and headache. left arm, hand and both feet went numb. nausea and headache ended within few hours. numbness in hand and both feet still exists 8 hours later. this was 2nd of the 3 doses. 9/25/09 Neurology consult received DOS 9/17/09. Assessment: Focal neurological symptoms after second HPV vaccine. Patient reports numbess for several hours in injected arm. Developed headache, nausea, and dizziness. Subsequently tingling sensation in left hand. Tired. Numbness in both feet. Tripped. Neurological exam - normal." nonenone. Numbness after taking Percocet. . During the same period patient was treated with none. Patient recovered.

HPV (GARDASIL) Side Effects Report #358471
HPV (GARDASIL) vaccine side effect was reported on 09/24/2009. Female patient, child 11.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Fatigue, "Complaints of blurry vision, R knee pain, fatigue. Started after 1st HPV vaccine 3-10-09. HPV# 2 5/12/09. HPV#3 9-15-09. Not seen by MD until 9/24/09. VA 20/20 ou, R knee exam normal, hemogram --> no anemia." Congen hip dysplasiaH/H 52.7/39; WBC 6500; pH 228; VA 20/20 ou . Patient recovered.

HPV (GARDASIL) Side Effects Report #357516
HPV (GARDASIL) vaccine side effect was reported on 09/16/2009. Female patient, 23.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Fatigue, "Information has been received from a registered nurse concerning her daughter who had been vaccinated with three doses of GARDASIL and after the second dose began experiencing headaches. The patient was not hospitalized. The patient was seeing a rheumatologist. Follow-up information was received from a 23 year old female patient. She reported she in June 2007, August 2007 and December 2007 was vaccinated with the first, second and third dose of GARDASIL (lot numbers not reported) respectively. There was no illness at time of vaccination and there was no pre-existing allergies, birth defects or medical conditions either and ~she was never a sick child or a sick adult~. On 01-OCT-2007 morning the patient started to experience migraines. The patient reported she had constant migraine since then. She had seen a neurologist multiple times. She had an MRI, and MRV and and MRA done in late 2007 and they all showed no complications. She had been prescribed amitriptyline hydrochloride, ZOMIG, FROVA, FIORICET, TOPAMAX, INDERAL, lisinopril among others, not one of these medications helped her migraines. she saw her original primary care doctor and now being followed by her new primary care physician. She had multiple infections, many times getting tested for Lyme disease (negative) and other blood tests (negative). She was in constant crippling pain from her migraines, as well as muscle joint pain and weakness, and frequently getting infections. She had been bruising especially easily since October 2007 also. She was tested for VON WILLEBRAND'S Disease, but results were negative here as well. Her new primary doctor had recently diagnosed her with chronic fatigue and referred her to a Rheumatologist, which she had scheduled an appointment. The patient strongly believe her symptoms are side effects caused by the GARDASIL vaccine. She reported she had none of these symptoms prior to receiving the vaccine, and there was no medical explanation to her symptoms as of yet. The patient was not recovered. The patient's events were co" "None HPV#3 given 12/14/07, Lot# 0890F, RA""magnetic resonance, ?/?/07, no complications; vascular imaging, ?/?/07, no complications; diagnostic laboratory, negative; MRV, ?/?/07, no complications; Lyme disease assay, negative; von Willebrand factor, negative" . During the same period patient was treated with Unknown. Patient recovered.

HPV (GARDASIL) Side Effects Report #357525
HPV (GARDASIL) vaccine side effect was reported on 09/14/2009. Female patient, child 12.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Fatigue, "Initial report received on 08 September 2009 from another manufacturer, report # WAES0908USA04708 whose initial reporter was a health care professional. ~Information has been received from a physician and an office manager concerning a 12 year old female patient with amoxicillin allergy who on 26-AUG-2009 was vaccinated with the first 0.5 ml dose of GARDASIL, concomitantly with a dose of (BOOSTRIX) (Lot : AC528046AA), a dose of VARIVAX (Lot : 664232/0498Y) and a dose of (MENACTRA) (Lot: U2815AA). The patient stated that after the vaccination she felt tired. She went home and had a seizure. the patient went to the emergency room and had computed axial tomography (CAT) done (results not reported). The patient was not hospitalized. The patient's mother called on 27-AUG-2009 at the physician's office and stated that her daughter was doing better. The physician also stated that her did not consider the events to be life threatening or to have caused the patient significant disability or incapacity. Upon internal review the seizure was considered as other important medical event. Additional information has been requested~." Patient has a penicillin allergy."26 August 2009: computed axial tomography (CAT), (results not reported)." . Patient recovered.

HPV (GARDASIL) Side Effects Report #357541
HPV (GARDASIL) vaccine side effect was reported on 09/17/2009. Female patient, 13.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Fatigue, "Extreme Fatigue, Nausea, migratory joint pain, joint swelling, abnormal TSH,T3,T4, headaches" "Asthma, Uticaria Pigmentosa 9/21/09 Medical records received w/:Menactra, Lot# U237BA, given LA 9/14/07; HPV #2, Lot# 1263U given LA 10/12/2007; Fluzone, Lot# U2448AA given 11/21/07 LA""Lyme test, JRA, Thyroid testing, CMV, EBV" . During the same period patient was treated with "Xyzal, Xopenex, Advair". Patient recovered.

HPV (GARDASIL) Side Effects Report #357621
HPV (GARDASIL) vaccine side effect was reported on 09/17/2009. Female patient, 26.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Fatigue, "Per pt phone call 9/14/09, pt received HPV #2 on 6/12/09. Went to ER 6/13/09 for fatigue & body aches, unable to hold 3 mo old son. Per pt. given pain injection and sxs resolved immediately. Told @ ER sxs due to HPV vaccine." None unknownNone . During the same period patient was treated with Mirena IUD. Patient recovered.

HPV (GARDASIL) Side Effects Report #357777
HPV (GARDASIL) vaccine side effect was reported on 09/21/2009. Female patient, 16.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Fatigue, Patient had her second injection of the Gardasil Shot in June 2009 and since then she has lost most of her hair. She is also getting scabs on her head also and itching. She is fatigued and very emotional. She continues to miss days at school because of the humiliation she faces at school with the loss of her hair. NoneNoneShe has had blood test to see if it is Thyroid and the test was well within the standards and the only other thing she has done different is this vaccination that she did not want to begin with. Her Doctor and her father insisted she have . During the same period patient was treated with None. Patient recovered.

HPV (GARDASIL) Side Effects Report #357797
HPV (GARDASIL) vaccine side effect was reported on 09/21/2009. Female patient, 18.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Fatigue, "extreme fatigue, mono, chronic strep throat, Hashimoto's, extreme face and body swelling, aching muscles. Got first vaccine 7/10/09 Lot 0072X in conjunction with Menactra vaccine. Second vaccine 12/22/08 Lot 1311X. Went to college on cross country scholarship. Started off season great. She said she started noticing that she was having trouble running mid October and that her legs felt heavy. Starting getting facial swelling second week of January. Went to doctor and they said it was allergic reaction. Got sick in February - dx with strep. Didn't get better. Went to ER end of March with extreme facial swelling. Told her it was allergy and gave her prednisone. Re-dx with strep again in early April and then mono April 9th. Got really sick and could not get better. Extreme facial and body swelling. Dx with Hashimoto's June 29th. and started thyroid treatment. Was not able to return to college in August and is still home. Started getting muscle soreness in July. Made Gardasil connection 2 weeks ago and is going to begin treatment by doctor who has helped several other gardasil patients. 10/13/09 Medical records received, Dates of Service 4/19/09-8/10/09. Dx: Other Specified Acquired Hypothyroidism, Abnormal Weight Gain, Oligomenorrhea, Fatigue, Thyromegaly. Presenting Sx: Pt. experienced an approximately 40 lb. weight gain over a 1 to 2 month period, additionally she c/o fatigue, trouble sleeping and staying asleep, facial swelling, swelling around eyes, acne, one terminal hair periumbilical, headaches and a heavy period. Pt. saw a nutritionist and was put on a diet plan. She experienced menarche at age 13 and had irregular periods for several years (approximately 6 periods/yr.). Ortho Tri-Cyclene-Low was initiated which she took for several years, but stopped early this year after missing several pills. She re-started the pill a few months ago. Concomitantly, she takes Synthroid, Cosyntropin and furosemide. She was diagnosed with mononucleosis in April, and tested positive for Epstein-Barr Virus in May. H" none"Ortho-tryclen Low. 10/13/09 Medical records received, Dates of Service 4/19/09-8/10/09. PMH: Streptococcal infection 4/9/09, ear infections, mononucleosis 4/12/09, Allergic to Penicillin.""mono - April 9, 2009 and June 30, 2009. Two Positive strep tests. Tested positive Hashimoto's - 6/30/2009. Thyroid Uptake and ultrasound confirmed thyroid on low side of normal -nothing accounted for extreme symptoms she was experiencing." . During the same period patient was treated with none. Patient recovered.

HPV (GARDASIL) Side Effects Report #357890
HPV (GARDASIL) vaccine side effect was reported on 09/14/2009. Female patient, child 10.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Fatigue, 9-11-09 off @ 2:30p (showing swelling/reddness) tired + in pain @ location. At midnight fever/hives. Visited ER @ 9:30AM 9-12-09. Tx with KEFLEX. NoneNone . Patient recovered.

HPV (GARDASIL) Side Effects Report #358392
HPV (GARDASIL) vaccine side effect was reported on 09/25/2009. Female patient, 20.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Fatigue, "dizzy, very bad headache, stiff joints, stiff and painful neck, trouble breathing and short of breath, fever, ligh-headed, tired, whole body sore to the touch--fainting. felt like I was becoming paralayzed-- was like this for 2 days. I WILL NOT HAVE THE 3RD DOSE." . Patient recovered.

HPV (GARDASIL) Side Effects Report #358624
HPV (GARDASIL) vaccine side effect was reported on 09/29/2009. Female patient, 15.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Fatigue, "approxiametly 2 weeks after dose 3 of Gardisil patient complaining od left hip pain. Seen 9/11/09 cough, leg pain headache, rib pain. Seen 9/15/09 epigastric pain, fatigue, back pain. Seen 09/23/09 flank pain, nausea, cough,congestion" NONENONE"Normal CBC,CMP, ESR, Urinalysis, urine culture, Amylase/Lipase, Abdominal Pelvic ultrasound" . During the same period patient was treated with Yaz Zyrtec. Patient recovered.

HPV (GARDASIL) Side Effects Report #358751
HPV (GARDASIL) vaccine side effect was reported on 09/28/2009. Female patient was vaccinated with HPV (GARDASIL). Patient symptoms: Fatigue, "Information has been received from a consumer via and internet blog concerning her daughter a student with a history of occasional migraine and pharyngitis streptococcal when younger who in September 2007, was vaccinated with the first dose of GARDASIL (Lot number not reported) and received her second dose of GARDASIL (Lot number not reported) in November 2007. Subsequently on an unspecified date the mother reported that GARDASIL made her daughter sick. It had attacked her daughter's central nervous system. The student now spent most of days confused, irritable, trying to find her past as she can not remember a lot of it. She was an honor student and just graduated in May and could not remember her graduation. She suffered with re-occuring Methicillin-resistant staphylococcal aureus infection (MRSA), chronic fatigue, migraines, hair loss, chest and back pain, weight gain, joint pain, seizures and mini strokes. The reporter stated that her daughter is trying to get her life back and she wont received the third dose of GARDASIL as she realized this was indeed what made her sick. It was unknown if the patient sought medical attention. At the time of the report, the patient's outcome was unknown. Seizures were considered to be an other important medical event. The reporter felt that her daughter symptoms were related to therapy with GARDASIL. Attempts to verify the existence of an identifiable patient and reporter have been unsuccessful. No further information is available." Migraine; Pharyngitis streptococcalUnknown . During the same period patient was treated with Unknown. Patient recovered.

HPV (GARDASIL) Side Effects Report #358968
HPV (GARDASIL) vaccine side effect was reported on 09/28/2009. Female patient, 18.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Fatigue, "My daughter received 1 dose of the GARDASIL vaccine and within 10 days had a fever, bleeding gums, canker sores inside the mouth, fatigue, no appetite. No one else in the family or friends were ill." . Patient recovered.

HPV (GARDASIL) Side Effects Report #358992
HPV (GARDASIL) vaccine side effect was reported on 09/30/2009. Female patient, 19.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Fatigue, "Notable increase in allergic reactivity and unwellness after first shot. Shot extremely painful going in. Patient has high pain tolerance, and stated it was the most painful thing that ever happened to her. Left tonsil and lymph node in left arm swollen and painful. After second shot anaphylactic reactions with symptoms increasing and cascading into respiratory distress, feeling heavy pressure on chest, severe digestive issues. Muscle heaviness and dibilitating fatigue and mental fog. Heaviness and weakness more pronounced in limbs. Symptoms exacerbated by even minor exertion. Each episode lasted longer than previous and became disabling to the point patient needed wheelchair. Could not stand up to shower, or raise arms to wash hair. Became airborne and skin reactive to strong chemical and food odors. Heart palpitations. Dizziness and faint feelings. Intolerant of even trace amounts of citric acid, and soy lecithin. Intolerant of all fruits, all vegetables or products source from them. Did not have menstruation for almost 2 years. Now has heavy cycles lasting weeks. Metallic taste in mouth. Heavy grey buildup on teeth despite no change in oral hygiene (meticulous oral hygiene). Severe skin problems on face. All over bloating, especially in face and abdomen. Rashes, hives, tongue swelling, painful eruptions on tongue. Episode of tongue swelling witnessed by allergist upon accidental exposure in office to trigger. Seen by Allergists, ENTs, Gastroenterlogists, Speech Therapist, Dietician, Screened for Asthma (negative), Multiple blood tests, and CT scans. Given protocol of multiple antihistamines, Gastrocrom, nebulizer. No effect. Seen at Neurology, various MRIs. Seen by Allergist, and Neurologists. Seen by PA. Had to take medical leave from college. Acupuncture for past year. 10/22/09 and 10/23/09 Medical records received from dates 9/11/08 to 5/6/09 DX: Anaphylactic reaction, secondary to multiple food products, worse with citric acid.Presenting symptoms: Pt. with strong complex history of allergic" None"Allergic to Dairy, egg, peanut, penicillin, ragweed, dust. 10/22/09 and 10/23/09 Medical records received from dates 9/11/08 to 5/6/09 PMH: anaphylactic reactions, multiple food allergies including peanuts, dairy, eggs, citric acid. PCN allergy, cefuroxime allergy. Pneumonia, migraines, syncope, menorrhagia, vocal cord dysfunction.""MRIs, CT scans, Blood tests for allergic disease indicators. All normal. Ischemic forearm test 10/22/09 and 10/23/09 Medical records received from dates 9/11/08 to 5/6/09 Diagnostics/Labs: CT sinus(-), PFT WNL, Ischemic Exercise test for" . During the same period patient was treated with "Zyrtec D, Depoprovera". Patient recovered.

HPV (GARDASIL) Side Effects Report #359467
HPV (GARDASIL) vaccine side effect was reported on 10/05/2009. Female patient, 26.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Fatigue, "Patient received Gardasil vaccine dose #2 on 10/1/2009, and that evening she complained of chills, nausea, and several episodes of vomiting. She reports no fever, and her symptoms resolved that night. She does report feeling fatigued for the next 24 hours after the onset of her symptoms but reports no futher complaints." nonenonenone . During the same period patient was treated with Necon 777 oral contraceptive. Patient recovered.

HPV (GARDASIL) Side Effects Report #359858
HPV (GARDASIL) vaccine side effect was reported on 10/06/2009. Female patient, 17.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Fatigue, "Information has been received from a physician concerning a female who on 02-JUL-2009 was vaccinated intramuscularly with a dose of GARDASIL (lot no. not reported). After vaccination, on an unknown date, the patient started experiencing flu like symptoms and had swelling in her groin area. Subsequently, the patient recovered. Follow up information has been received from a licensed practical nurse who regarding a 17 year old female at 134 pounds weight and 52 inches with drug allergies to AUGMENTIN, OMNICEF, BACTRIM who on 02-JUL-2009 was vaccinated intramuscularly in the right deltoid with her first dose of GARDASIL (Lot#661954/1131X) at 11:50 am. It was reported that 5 - 7 days following GARDASIL first injection on 07-JUL-2009, the patient experienced cervical lymphadenopathy, sore throat, headache, dizziness, fever (TM 102.3), hives, nausea, diarrhea and loss of appetite. On an unknown date some symptoms dissipated but the patient had prolonged (10 weeks) of out cervical lymphadenopathy, fatigue and dizziness. Extensive work-up by a hematologist, ENT (ears, nose, and throat), infectious disease and endocrinology. At the time of the report the patient was improving. the liscensed practical nurse considered the patient's experience to be disabling. Additional information has been requested. 10/19/2009 records from PCP, ENT, Hematologist and Endocrinologist visits. Patient 5 days post vaccine had sx of: cervical lymphadenopathy, headache, sore throat, fever, urticaria, nausea, diarrhea, dizziness , malaise, fatigue and anorexia. Initially dx'd with strep pharyngitis and was on ABX x 2 and Medrol dose pak, lymph node size decreased at first but then rebounded and have continued to enlarge since then. PE notes tender , mobile bilateral enlarged cervical lymph nodes appox 2-3 cm. ED visit 9/10/2009: sx frequent urination, hematuria. DC Dx UTI, Tx'd with ABX/Pyridium. Final Dx: Hashimoto's Thyroiditis, Viral lymphadenitis with mono-like illness. Tx: modify activities/rest. 11/5/2009 records from OB-GYN MD" Drug hypersensitivity"PMH: Migraines, Asthma Allergies: Amoxicillin, Augmentin, Omnicef, Sulfa""oral T, 102.3 Lab: CBC, Lipid profile, CMP, LDH, ESR, CMV titer, IgM titer, Toxoplasmosis serology WNL, TSH 5.1 high, Cat scratch panel. Mono-test, PPD, EBV, ANA negative, ACE normal, Monocyte ct 15.6 high, Basophil ct high at 2.05, Thyro" . During the same period patient was treated with Unknown. Patient recovered.

HPV (GARDASIL) Side Effects Report #360063
HPV (GARDASIL) vaccine side effect was reported on 10/07/2009. Female patient, 14.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Fatigue, "Information has been received from a physician and a licensed practical nurse concerning a 13 year old female with no pertinent medical history or no known drug allergies, who on 24-SEP-2009 was vaccinated with 0.5 ml of the first dose of GARDASIL (Lot number 659655/1486U) intramuscularly on the right arm. On the same day the patient received a dose of hepatitis A vaccine (inactive) (AVENTIS) (Lot number: AHAVB291AA) on the right arm, a dose of VARIVAX (Lot number: 661334/0737X) on the right arm, MENACTRA (Lot number U2663AA) left arm. The patient became lightheaded, had pain at the injection site, was dizzy and experienced numbness on the right leg while still in the office after vaccination. the patient was told if the symptoms got worse, to call the office or go to the emergency room (ER). The patient continued to feel bad, vomited and felt weak so the patient went to the ER. The patient was hydrated and got better. The physician reported that the patient recovered maybe on 01-OCT-2008, reported as ~1 week after the first dose of GARDASIL~. On 25-SEP-2009, the patient was in the office for a well visit and received the second dose of GARDASIL (Lot number 662404/0312Y) on the left arm, a dose of influenza virus vaccine (unspecified) (Lot number: U3177AA) and a dose of hepatitis A virus vaccine inactivated (Lot number 663913/0206Y) on the right arm. The patient then experienced severe pain at the injection site on the left arm. The nurse put ice on the injection site because the pain was so extreme the patient was crying. The patient was told to call the office if the symptoms got worse. The patient went to the ER. The patient had no fever. The ER notes from 27-SEP-2009, at 17:30 stated that the patient started to feel, on 25-SEP-2009, lightheaded and complained of pain all over-severe myalgia. The patient had difficulty moving her left arm and left leg. The patient got better 26-SEP-2009, but symptoms got worse 27-SEP-2009 night. The patient had nausea, dizziness sometimes, tired, aches and pains all over the b" None PMH: none Allergies: NKDA"diagnostic laboratory, 09?/??/09, Basal metabolic normal; complete blood cell, 09?/??/09, normal Labs: CBC, BMP, UA, urine pregnancy test all normal/neg" . Patient recovered.

HPV (GARDASIL) Side Effects Report #360064
HPV (GARDASIL) vaccine side effect was reported on 10/07/2009. Female patient, 13.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Fatigue, "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" "None 10/16/09 Received medical records from Ophthalmology and Rheumotology consultations from 12/18/07 to 7/13/09 PMH: chronic iritis, joint pain, Lyme disease, steroid induced glaucoma. Head injury 7/19/04 hit head on road, blurry vision, HA advised ER visit.""diagnostic laboratory 12/18/07, Lyme's disease test was negative 10/16/09 Received medical records from Ophthalmology and Rheumotology consultations from 12/18/07 to 7/13/09 Diagnostics/Labs: 12/18/07 Lyme Ab WB IgG /IgM 1.23(H), Lyme Ab E" . During the same period patient was treated with None. Patient recovered.

HPV (GARDASIL) Side Effects Report #360086
HPV (GARDASIL) vaccine side effect was reported on 10/08/2009. Female patient, 17.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Fatigue, "Hair loss began within a few days of Gardasil. This continued at a dramatic rate so that she has lost what mom believes to be up to 50% of her hair volume. Has also had extreme fatigue and muscle soreness. 1/4/2010 PCP records for 8-11/2009, on 11/9/2009 patient with c/o's hair loss, fatigue, facial flushing" nonenone PMH: None Allergies: NKDA"Labs: CRP, Amylase, ESR, C3, C4, CH50, ANA, Anti-DNA, SSa, SSb, Jo1 AB all wnl/neg, TSH low, CBC wnl, UA + bacteria but urine culture negative, CMP , iron, iron sat and TIBC wnl, Antiphospholipid AB neg" . Patient recovered.

HPV (GARDASIL) Side Effects Report #360409
HPV (GARDASIL) vaccine side effect was reported on 09/25/2009. Female patient, 16.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Fatigue, "Client given dose #2 GARDASIL, left treatment room, returned within 5 min. Stated began to feel nauseous, headache, dizzy almost immediately after left room. RTC BP 110/60, P 80 regular; c/o eye sensitivity to light, feeling of fatigue and headache while here. No apparent breathing difficulty. Seen by PCP-advised not to have dose #3 GARDASIL." "Cold symptoms no fever, cough and runny nose"None . Patient recovered.

HPV (GARDASIL) Side Effects Report #360502
HPV (GARDASIL) vaccine side effect was reported on 10/12/2009. Female patient, 20.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Fatigue, "I received the second shot of Gardasil vaccine on July 3, 2008 at 7:00 PM in my left deltoid. I immediately developed a rash following 15 minutes after vaccination. An hour after the injection, I was feeling dizzy and disoriented. I was admitted to the emergency room of the Tri-City Medical offices on July 14th, due to projectile vomit, dehydration, and weakness. I was dangerously dehydrated after throwing up more than 15 times in a single hour and was unable to swallow my own saliva without throwing up again. I was incapacitated and unable to walk, requiring to be carried into the hospital. Following my emergency room visit, I started experiencing hyper-sensitivity to my environment and products I used in my daily routine; a symptom characteristic of Polysorbate 80 poisoning considering it has been known to produce reactions of anaphylaxis, which is a constituent in the Gardasil vaccine. I experienced allergic reactions to face creams that were a customary part of my routine for years, inducing swelling of my face and nasal passages. These reactions continued without explanation and though I discontinued the use of all products that created reactions, my body's hyper-sensitivity did not dissipate. On August 2, 2008 I applied my acne cream Retin-A micro at night. By the morning, the entirety of my face had become severely swollen and did not recede completely for two days. It was so severe that it shut my right eye completely. Retin-A had never been a problem before. I was then bitten by an unknown insect in my sleep a few days later and awoke to find a swollen growth the size of a golf-ball on my arm. It was extremely itchy and an incredible ache spread through my arm and up to my shoulder. The following morning the swelling had disappeared and the ache had receded. On August 9, I started to loose all my sensation in my legs. The numbness slowly spread first throughout the left side of my body, including my face and head. In the following two days it consumed the rest of my body, numbing in" Tonsilitis"None 10/21/09 Medical records received for dates 6/22/08 to 10/15/09 PMH: chronic sinusitis, malaise/fatigue, anxiety disorder, asthma. Allergy to tetracycline, chloroquine, EEC, retin A, cipro, gardasil vaccine.""I'm seeking a thorough blood panel by a toxicologist, because the primary cause of my illness is based on the toxins of Gardasil. Other diagnostic tests cannot and haven't identified the cause of my symptoms, despite them being ongoing. 10" . During the same period patient was treated with None. Patient was hospitalized Patient recovered.

HPV (GARDASIL) Side Effects Report #360564
HPV (GARDASIL) vaccine side effect was reported on 10/13/2009. Female patient, 17.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Fatigue, "10-309 Sz- 1st episode seizure - MRI negative - 10am. 10-12-09 Left hand weakness > given phenytoin - 7pm. 10/23/09 Medical records received for ER visits DOS 10/03 and 10/09. FINAL DIAGNOSES: Seizure disorder, left arm parasthesia. On 10/3 first time seizure w/prolonged postictal period. Witnessed by parents. Hard to awaken. H/O extremity shaking, numbness and tingling, dropping things w/o LOC. Usually in the am. PE wnl, (+) fatigue only. Discharged to home. Planned neuro follow-up. 10/9 patient returned to ER with c/o L hand, coldness, tingling and numbness. Subtle pain 1/3 up to elbow. Equal grasp. Developed weakness bilat legs in ER. Phenytoin tx. Resolved. Discharged to home. EEG and Neuro follow-up as planned." NoneNone. PMH: Asthma. ALLERGIES: none."MRI negative; EEG pending. LABS & DIAGS: chloride 108 (H), anion gap 16 (H), MRI brain- no evidence of acute infarct, non-specific white matter changes may be seen in setting of migraine HAs, gliosis, vasculitis, demyelination or Lyme's, L" . During the same period patient was treated with None. Patient recovered.

HPV (GARDASIL) Side Effects Report #360623
HPV (GARDASIL) vaccine side effect was reported on 10/13/2009. Female patient, 16.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Fatigue, "Child became flushed about 15 minutes after administration. Progressed to dizziness and became unconscious at home. Was difficult to arouse, unknown seizure activity. Prednisione 30 mg was given, and child was taken to Emergency Room, and was evaluated. Has severe pounding headache, general body aches and very tired. Has slept excessively. 12/09/09 Immunization records received 12/10/09 MR received for DOS 10/12/09. DX: vaccine reaction to gardasil. After receiving vaccine, Pt felt flushed, lightheaded, became unresponsive for 10-15 sec, body pain. tx: orapred, motrin. Pt discharged home in stable condition." DX studies: negative for influenzaPMH: IBS . Patient recovered.

HPV (GARDASIL) Side Effects Report #360687
HPV (GARDASIL) vaccine side effect was reported on 10/13/2009. Female patient, 18.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Fatigue, "I have been experiencing bilateral muscle fatigue and pain in feet and legs for almost three years now. They began when I was a 19 year old female pre-medical college student with a history of moderate alcohol use and smoking, and no major diseases except mild scoliosis as an adolescent and shingles at age 17, which indicates some auto-immune issues. I wear orthotics for my flat feet and have a history of swollen Achilles tendons and other feet problems. I was in great physical shape as I exercised five times a week for an hour. After volunteering in a hospital, on my feet for three hours, I experienced a sudden onset of intense foot pain in February 2007 which disabled my mobility for the rest of the day. From then on, my leg muscles were extremely weak and fatigued so much that I was not able to climb up stairs or walk from my dorm to classes on campus. I also experience sporadic pain throughout different places in my legs and feet, including knee, ankle, thigh, and foot pain. Sometimes the pain is so bad I will all of a sudden be forced to limp as I cannot put any pressure on my foot after it has a sort of spasm. I sometimes experience these spasms while driving and have to pull over and can no longer drive, and I can no longer drive longer distances. I also experience stiffness and aches in my legs and feet late in the night, in the mornings, and after keeping them in one position for awhile. After I drink alcohol, my symptoms become worse and more frequent for the following week proportionate to the amount of alcohol consumed. Podiatrist Evaluation Feb. 2007: Podiatrist examined my orthotics which were too old and diagnosed me with congenial pes planus and limb pain. Podiatrist took a slipper cast of each foot and made orthotics which corrected the pes planus as best as they could. Podiatrist ordered physical therapy three times a week to strengthen my leg muscles which were extremely weak during strength and resistance testing. Podiatrist referred to a back specialist to determine if any lower back proble" NoAllergic to ceclor- Back specialist took X-Ray of lower back to determine if any lower back problems at the Center are influencing the leg issues in March 2007. X-Ray was normal. - Orthopedist then ordered a nerve conduction test and electromyography (EMG) . During the same period patient was treated with Yasmin. Patient recovered.

HPV (GARDASIL) Side Effects Report #360753
HPV (GARDASIL) vaccine side effect was reported on 10/06/2009. Female patient, 14.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Fatigue, "2 wks post vaccine -> myalgia/fatigue. Wt loss. Ultimate diagnosis Addison's Disease 8/09. 10/26/2009 PCP and Endocrinologist records, initial visit 8/13/2009. Patient with c/o's fatigue, arthralgias, myalgias and an 18 lb unexplained wt loss. Baseline cortisol levels were <1, patient dx'd with Addison's disease. Tx: started on hydrocortisone bid." NoneNone PMH: none Allergies: NKDA"Cortrosyn stim was flat Labs: CBC, CRP, ANA, VIT D, Rennin, Blood Mercury normal, BMP : Na low, ACTH, Varicella AB test neg, Lyme test neg Dx studies: MRI Brain wnl" . Patient recovered.

HPV (GARDASIL) Side Effects Report #360944
HPV (GARDASIL) vaccine side effect was reported on 10/14/2009. Female patient, child 12.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Fatigue, "Information has been received from a physician concerning a 13 year old female who in 2008 was vaccinated with GARDASIL. The patient completed the series of GARDASIL in 2008 and was recently diagnosed with Autoimmune Thyroiditis (2009). The patient sought her pediatrician. At the time of the reporting, the patient had not recovered from the event. Follow up information received on 06-OCT-2009 from a physician via medical records indicated that the patient was female student, with no medical history, known allergies or illness at the time of vaccination. The patient's family history included hypothyroidism and polycystic ovary syndrome (mother), aniridia (brother) and hypothyroidism (paternal grandmother). On 26-NOV-2008 the patient was vaccinated with a third dose of GARDASIL (lot # 650557/0072X), intramuscularly into the left arm. Secondary suspect vaccination given on the same day included a third dose of FLUZONE, (lot # U2760AA), intramuscularly into the right arm. The patient presented with her mother in the physician's office on 19-MAY-2009, complaining of feeling tired, muscle aches and requiring long naps. She has been experiencing these symptoms for the last couple of months (end of school year). The myalgias were generalized and most pronounced in her knees, hips and shoulders. TYLENOL helps some. She has been sleeping well-getting 8 hours of sleep without significant interruption. She generally feels well rested in the morning. She has not been short of breath and she denies fever, chills, night sweats, nausea, vomiting. She started her menstrual periods last July and they have been irregular. Her mother noticed that the fatigue and body aches were more pronounced just prior to her most recent menstruation. She had no urinary problems and she denied increase thirst. She grew approximately 2 inches in height in the past year. The physical exam was within normal limits. The patient developed hypothyroidism diagnosed on 19-MAY-2009 with symptoms beginning in March 2009 (approximate). The patient had a comp" Unknown"blood pressure, 114/5; serum TSH, 05/19/09, 12.06 UIU/, high; neutrophil count, 05/19/09, 53 %, lymphocyte count, 05/19/09, 36 %; monocyte count, 10 %; temperature measurement, 36.2 degrees C; respiratory rate, 18; total heartbeat count, 52" . During the same period patient was treated with Unknown. Patient recovered.

HPV (GARDASIL) Side Effects Report #361318
HPV (GARDASIL) vaccine side effect was reported on 10/17/2009. Female patient, 17.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Fatigue, "severe pain at injection site, since that time has started blacking out, seizures, migraines, heart palpitations, blood pressure control problems, nausea, severe pain in extremities, tingling in arms and legs,severe tiredness, low quality of life. 11/4/09 Medical records received for date 6/5/08 to 10/28/09. 6/5/08 Pt established care at PCP with initial c/o multiple syncopal episodes in past few wks. Mostly when changing positions lying/sitting. DX: syncope, irreg. menses, sinusitis, insomnia. Multiple OV for c/o syncope, body aches, dizziness, chest pain, ear pain, DX: syncopal episodes, orthostatic HTN, muscle pain, chest pain, tachycardia, depression/anxiety, autonomic dysfunction." none"allergic codeine, pcn""MRI, MRV, CAT SCANS, numerous blood work studies, EEG, EKG, Holt monitor, tilt table testing." . Patient recovered.

HPV (GARDASIL) Side Effects Report #361427
HPV (GARDASIL) vaccine side effect was reported on 10/19/2009. Female patient, 23.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Fatigue, 09/2008 GASTROINTESINAL PROBLEMS 10/2008 WEIGHT LOSS 11/2008 SWOLLEN GLANDS LEG PAINS/RESTLESS LEGS LOST 30 LBS IN 3 MONTHS/TIRED FATIGUE/WEAKNESS -CONTINUED UNTIL PRESTENT DAY NONE"NONE. PMH: ADD, Anxiety, Heart Murmur, tonsilectomy.""ENDOSCOPY, COLONOSCOPY, TONSILECTOMY, BLOOD WORK, SWALLOWED CAMERA." . Patient recovered.

HPV (GARDASIL) Side Effects Report #362933
HPV (GARDASIL) vaccine side effect was reported on 10/27/2009. Female patient, 13.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Fatigue, "Extreme Fatigue. Lethargic reaction. Extreme Weakness in joints and muscles. Almost non responsive. Emergency room visit resulting in IV, antibiotic injections and short stay in hospital." NoneNone"Blood Work Up, Strep Test." . Patient was hospitalized Patient recovered.

HPV (GARDASIL) Side Effects Report #363230
HPV (GARDASIL) vaccine side effect was reported on 10/27/2009. Female patient, 13.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Fatigue, "chest pain, difficulty breathing, headache, extreme fatigue," none"echocardiagram,chest x-ray(2), MRI of the brain, spinal tap, eye exam(2),blood work, strep cultures, mono test, etc.,etc.," . Patient was hospitalized Patient recovered.

HPV (GARDASIL) Side Effects Report #363546
HPV (GARDASIL) vaccine side effect was reported on 10/28/2009. Female patient, 14.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Fatigue, "Information has been received from a physician concerning a female patient who on approximately 12-AUG-2009, ~three weeks ago~, was vaccinated intramuscularly into the deltoid with a dose of GARDASIL. The next morning after vaccination, on approximately 13-AUG-2009, the patient had experienced headaches and dizziness every day for the last three weeks. The patient also had not been able to concentrate in school. The patient sought medical attention by an office visit. The patient recovered from all symptoms on 02-SEP-2009. Follow up information was received from the physician who reported that the 14 year old patient on 18-AUG-2009 was vaccinated with her first dose of GARDASIL (Lot No. 663452/0671Y). On 19-AUG-2009, the patient experienced severe headache and dizziness. The patient was prescribed ANTIVERT for the treatment of dizziness. Although the patient was going to school, she was very tired and had difficulty concentrating. The patient sought unspecified medical attention. At the time of the report, the patient had recovered from all symptoms. The patient's headache, dizziness, disturbance in attention, and fatigue were considered to be other important medical events by the reporter. No further information is available. 11/2/09 Medical records received for date 9/2/09. DX: Adverse rx to vaccine. Presenting SX: c/o severe HA, dizziness x3wks. Pt states began after first vax of gardasil." UnknownUnknown . During the same period patient was treated with Unknown. Patient recovered.

HPV (GARDASIL) Side Effects Report #363769
HPV (GARDASIL) vaccine side effect was reported on 10/29/2009. Female patient, child 12.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Fatigue, "Madi started getting severe stomach pains approx. 24 hours after Gardasil vaccine. She threw-up violently at least 13 times. For the next 3 weeks she suffered from fatigue, joint pain, numbness and tingling in her fingertips, fevers, nausea, sore throat, skin peeling off of her hands, muscle weakness in her legs. 11/30/09: Infectious disease consultation received for date of service 8/05/09. Dx: Viral syndrome. Presents with c/o sore throat, fever, emesis, joint pain and tingling and stiffness of fingers following vaccination. MD states sx. unlikely related to vaccine, rec. continue HPV series. 12/23/09 clinic records and laboratory reports received for DOS 07/28/09-07/29/09. DX: Acute Viral Pharyngitis. Patient presented with c/o sore throat, dysphagia and vomiting. 12/23/09 clinic records received for DOS 08/04/09-10/05/09. DX: Viral infection and acute pharyngitis. Presents with c/o headaches, fever, vomiting, joint pain, body aches, sore throat, cough and decreased appetite. Plan: Ibuprofen, fluids and rest." NONE"12/23/09 PMH: Pneumonia, Corneal abrasion, scoliosis.""Full blood work up at Children's Hospital in Omaha, NE. Also tested for H1N1, strep, seasonal flu, meningitis. Went to Infectious Disease as well. 11/30/09: Infectious disease consultation received for date of service 8/05/09. Labs and di" . Patient recovered.

HPV (GARDASIL) Side Effects Report #364162
HPV (GARDASIL) vaccine side effect was reported on 10/31/2009. Female patient, 23.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Fatigue, "Tightness in abdomen, violent vomiting, diarreha, fainting, weakness, fatigue 11/03/09 Vaccine record received. 11/05/09 Medical records received for DOS 10/30/09. Patient developed nausea, diar and vomiting several hours s/p vaccine. Hot and cold flashes. ED visit. All bld wrk WNL. Fluid replacement and antiemetics. Felt better. D/c to home." NoneNone. Allergies: None."Labs and Diags: WBC, BMP and UA WNL." . During the same period patient was treated with Nuva Ring. Patient recovered.

HPV (GARDASIL) Side Effects Report #364964
HPV (GARDASIL) vaccine side effect was reported on 11/03/2009. Female patient, 22.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Fatigue, "Information has been received from a medical assistant, for GARDASIL, a Pregnancy Registry product, concerning a 22 year old female with penicillin allergy who on 05-DEC-2008 was vaccinated with the first dose of GARDASIL (lot number unspecified). On 03-FEB-2009 the patient received the second dose of GARDASIL (lot number unspecified). On 10-JUL-2009 the patient received the third dose of GARDASIL (lot number: 661846/1312X, 0.5ml, IM. There was no concomitant medication. The patient's last documented period was 3 months ago, in approximately April 2009; however, the patient had sporadic periods. On 23-JUL-2009, the patient was seen in the office for symptoms of body aches, fatigue, nausea, vomiting and myalgia. On 23-JUL-2009 a urine pregnancy test was conducted and the result was positive for pregnancy. HCG quantitative test was ongoing (result unknown). The patient's estimated delivery date would be on 28-JAN-2010. At the report time the patient was pregnant. Follow up information has been received from a medical assistant concerning the 22 year old female who was vaccinated with 3 doses of GARDASIL on 05-DEC-2008, 03-FEB-2009 and 10-JUL-2009 respectively. The reporter noted that the patient terminated pregnancy on an unspecified date. The patient last menstrual period was on 27-APR-2009. The estimated delivery date (EDD) would be on 01-FEB-2010. At the time of the report, the outcome was unknown. No further information is available." Pregnancy NOS (LMP = 4/27/2009); Penicillin allergy"urine beta-human, 07/23/09, positive for pregnancy" . During the same period patient was treated with None. Patient recovered.

HPV (GARDASIL) Side Effects Report #365427
HPV (GARDASIL) vaccine side effect was reported on 11/05/2009. Female patient, 15.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Fatigue, "Started passing out at school, incoherent and did not recognize people. Was taken to hospital emergency complete blood work including drug testing done, all came back negative. CAT scan done came back negative. Unable to recognize family member that came to hospital and friends. While in hospital she had what we now know 3 seizures. She becomes completely quiet, tears running down face and does not respond to any one. They released her saying it was a reaction to her asthma inhaler. Went to pediatrician next day who thought it may be drugs but drug panel at hospital was negative. Her personality completely changed went from outgoing and friendly, to quiet and tired. On Wednesday September 5 she returned to the pediatrician who suggested she see a specialist she suspected patient was having seizures and her memory had still not returned. Started seeing Dr. on Sept. 6 and he confirmed seizures put on meds. After seizures she becomes very aggravated and mean then take a nap that can last anywhere from a couple hours to all day. There were 2 occasions she lost control of her bodily functions. In October she started have short term memory loss and would ask the same question over and over again. She was taken out of school and put on hospital/home studies for the remainder of her sophmore year. She was taken off all med in the spring of 2008 and her last seizure was in Nov of 2008. 12/16/09 Medical records received for dates 9/16/07 to 3/14/08. DX: seizures. Multiple f/u appts for seizure monitoring. Pt w/ active seizure disorder. 12/17/09 ER records received for date 8/30/07. DX not documented. SX: c/o asthma attack, parents states pt not acting right since the asthma attack. Assessment: flat affect, disoriented. 1/4/2010 Ed note for 9/20/2007, patient with c/o's dizziness, no tx noted," noneasthma Allergies: NKDA"CAT Scan, EEG, MRI, Blood work ups Diag/Labs: CT(-), UA(-), tox screen(-), MRI(-), EEG abnormal." . Patient recovered.

HPV (GARDASIL) Side Effects Report #365902
HPV (GARDASIL) vaccine side effect was reported on 11/08/2009. Female patient, 15.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Fatigue, "Patient came to parent reporting numbness and tingling of legs/feet. She fell to the ground and begin seizing. Her aunt, a nurse manager, recognized the symptoms of a seizure and accompanied parent to the ER. She was transported to another hospital and hospitalized 10/05-10/10/2009. Patient has continued to have unexplained seizures since that time. Other symptoms include: low blood pressure, headache, fatigue, hyperventilation, achy and shaky legs. 11/13/09: Discharge summary and hospital records received for dates of service 10/8/09 to 10/13/09. Dx: Psychogenic nonepileptic seizures. Assessment: Presented with episodes of lightheadedness, dizziness, near syncopy or syncopy, numbness of legs & feet, feelings of her lips tingling as well as episodes of hyperventilation. Eventually sx. increased to loss of awareness and seizure-type activity. Seen in the ED 3 times in 24 hrs. prior to admission for apparent seizure activity. Admitted to ICU for observation. Video EEG noted several events judged nonepileptic in nature. The apparent seizures were determined to be a conversion disorder. Pt. discharged to home with instructions to stay home from school, not drive, and to be supervised when bathing. 11/23/09 Hosp. records received for date 10/8/09. DX: Seizure vs pseudoseizure. Presenting SX in ER: active seizure several episodes, upper body shaking, crying. MD witnessed episode, no LOC. Pt. seen in ER 10/7/09 for episodes of hyperventilation. ICD9 codes: 786.01, 780.39, 782.0" None"None. 11/13/09: Discharge summary and hospital records received for dates of service 10/8/09 to 10/13/09. PMH: Synovitis of the hip, irritable bowel disorder, sinusitis, rash from Amoxicillin. 11/23/09 Hosp. records received for date 10/8/09 PMH: sinusitis, hyperventilation, low BP.""EKG, various lab workups (urine and blood), CT, MRI and video EEG. 11/13/09: Discharge summary and hospital records received for dates of service 10/8/09 to 10/13/09. Labs and diagnostics: Head CT (-), CBC (WNL), BMP (WNL), TSH (NL), Mag" . During the same period patient was treated with None. Patient was hospitalized Patient recovered.

HPV (GARDASIL) Side Effects Report #365909
HPV (GARDASIL) vaccine side effect was reported on 11/08/2009. Female patient, 23.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Fatigue, "Lymph node in neck became swollen. Feeling tried and exhausted and dizzy all day. Cannot perform normal daily functions because of tiredness and near syncope.11/12/2009 MD records for 10/20/2009, patient with c/o's lump lt side of neck. PE noted a small, mobile, 1cm mass. Tx: observation Dx neck mass ICD-9 code 784.2" noasthma PMH: Asthma Allergies: KeflexDx studies: US of the neck impression lymph node . During the same period patient was treated with "Birth Control (Seasonique), Asmanex, Albuteral, Mobic". Patient recovered.

HPV (GARDASIL) Side Effects Report #365994
HPV (GARDASIL) vaccine side effect was reported on 11/06/2009. Female patient, 18.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Fatigue, "Information has been received from a physician and a registered nurse concerning an 18 year old female patient with shoulder injury who on 02-SEP-2008 was vaccinated with the first dose of GARDASIL (lot # 661530/0575X) and on 14-OCT-2009 received the second dose of GARDASIL (663452/0671Y). There was no concomitant therapy. On 15-OCT-2009, the next day after vaccination, the patient complained of headache, fever and general fatigue. The fever went away after about a day. The headache persisted. It was reported that there was stomach discomfort as well. On an unspecified date, the patient ended up being treated at urgent care with IV fluids for dehydration and IV TORADOL for headache. The physician stated that the patient has been out of school for this entire time and unable to drive because of dizziness and light sensitivity to the eyes. On 27-OCT-2009, the patient called to the office because she thought that she was sick with flu like symptoms. The physician also stated that the patient was debilitated and that she was sleeping 8 to 10 hours a day. It was also reported that the patient could not drive or do anymore of her normal activities. This had been ongoing for 2 weeks as of 28-OCT-2009. No laboratory or diagnostic tests were performed. At the time of reporting the patient was on around the clock pain relievers. Upon internal review the patient's experiences were considered to be disabling. Additional information has been requested." Injury to shoulder NOSNone . During the same period patient was treated with None. Patient recovered.

HPV (GARDASIL) Side Effects Report #366346
HPV (GARDASIL) vaccine side effect was reported on 11/10/2009. Female patient, 26.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Fatigue, "BODY ACHES, MUSCLE WEAKNESS. FIRST THREE WEEKS FATIGUE, DIFFICULTY BREATHING SPECIALLY WHEN TALKING FOR MORE THAN 20 MINUTES. 11/13/09 Medical records received for dates 9/2/09 to 11/10/09. OV 9/2 received gardasil vax dose 1. OV 9/10 wellness exam visit pap WNL. OV 10/9 pt c/o body aches, muscle pain, dizziness, SOB. DX: fatigue, dyspnea, impacted cerumen. OV 10/13 c/o SOB, allergies, fatigue. Referral given cardio/pulm eval. 11/9 pt called MD stated left side muscle weakness where gardasil vax given, difficulty breathing. 11/10 pt called MD stated sx resolved. Declined further gardasil vax." NONE"ALLERGIES(DUST, MOLD, CATS) 11/13/09 Medical records received for dates 9/2/09 to 11/10/09 PMH: Anemia, HSV1""DOCTORS CAN'T FIND ANYTHING UNUSUAL IN BLOOD TESTING, BUT I WAS REFERRED TO A PULMONOLOGIST AND I'M CURRENTLY DOING SOME MORE TESTING. 11/13/09 Medical records received for dates 9/2/09 to 11/10/09 Diagnostics/Labs: EKG(-), CXR(-), CBC WNL" . Patient recovered.

HPV (GARDASIL) Side Effects Report #366928
HPV (GARDASIL) vaccine side effect was reported on 11/12/2009. Female patient, 14.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Fatigue, "Initially after the vaccination Jasmyne felt hot and passed out. She was woozy and we waited until she was more stable so we could take her home. Within a week roughly she started to have random fainting spells which she had never experienced before. Additionally, she has numbness/tingling in arms and legs and intermittent chest pains. She is constantly fatigued and because we never know when she will have a fainting episode she is homeschooled. She tends to be very weak and dizzy after she faints and it can take a hour or so for her to regain any strength. Many times her legs give out when she is walking and she falls down. She has seen multiple doctors and specialists. We just monitor her condition and make sure stay hydrated and we also increased her sodium to try and combat the fainting which has been slightly effective. The biggest issue now is the constant fatigue and pain she experiences regularly. 11/16/09 Medical records received fro DOS 1/27/09. PCP notes documents vaccine dates and h/o beast pain, redness, swelling. ABx therapy." No"h/o beast pain, redenss, swelling.""Multiple blood tests, cardiac stress tests, EEG, MRIs, & general physical exams." . Patient recovered.

HPV (GARDASIL) Side Effects Report #367044
HPV (GARDASIL) vaccine side effect was reported on 10/01/2009. Female patient, 14.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Fatigue, "11/16/2007 approx. 1:30 p.m. Fri at school admin principal called. Pt was feeling very ill. Could not walk and feeling body weak. Unable to express herself went to ER. Blood work, CT scan EGD test. On 11/18/2007 went back to ER Hosp. Referred to Neurologist w/meds. 12/04/09 ED records received for DOS 11/16/09. Pt. brought to ED after fainting at school, feeling very tired; c/o shortness of breath, painful urination. Discharged home. DX: ataxia vs. pseudoataxia 12/04/09 ED records received for DOS 11/18/09. Pt presents with vertigo, headache, hot flashes, ~legs not cooperating~. Discharged home." Vaccines was painful at time12/04/09 PMH: ADHD; NKDA; scoliosis; anxiety attackBlood Labs CT Scan; ECG test; EMG test; Pelvic test. Eye test; head; neck; back MRI. Done twice. 3 Neurologist MD (seen) meds. 12/04/09 Labs/Diagnostics:CT brain scan : no evidence of acute intracranial pathology; AST 10 (L); ALT 28 (L); . Patient recovered.

HPV (GARDASIL) Side Effects Report #368015
HPV (GARDASIL) vaccine side effect was reported on 11/13/2009. Female patient, 14.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Fatigue, "Started flu sx evening 11/6 (presumed H1N1). Took Ibuprofen only. On 11/11 had staring spell, became nonverbal. Ambulance got normal glucose. Slowly improved over 2 hr in ER. Diagnosed ~fatigue, 1st menses~ I think this was a CNS symptom of influenza. Seen in office 11/12 normal neurological exam. Phone next day still sleeping a lot. Improving at date of report. Update: Pt hospitalized 11/15 - 17/09 for altered mental status. Extensive work up [EEG, LP, MRI, CT, Viral titers and PCR's] failed to identify a cause. As of today she is definitely improved." No; sister had flu 11/5/09NoIn ER: normal BMP; CBC; HCG; Mono spot; drug screen. . During the same period patient was treated with No; Differin topical started that day. Patient was hospitalized Patient recovered.

HPV (GARDASIL) Side Effects Report #368235
HPV (GARDASIL) vaccine side effect was reported on 11/17/2009. Female patient, 17.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Fatigue, "Patient woke up feeling faint and cold. She was light headed and complained at school to several people that she felt faint. Then she did faint and she had a seizure that lasted 2 minutes. She was taken to the hospital by the paramedics. MRI, EEG all tests were normal. No explanation for this event. Next shot is June 2008. Patient appears immune-compromised. She is constantly sick and complains of fatigue. She returns to college. She is sick from Sept thru Dec. No amount of antibiotics helps. Her hair is falling out. She is pale, listless, without energy. On Dec 27, 2008, she passes out again, first thing in the morning after feeling cold and faint. Again she suffers a seizure and is unconscious for 2 minutes. She is taken to the hospital and no explanation can be found for this drop in blood pressure, syncope and seizure. Eleven months later she has another episode exactly like the first two. Throughout the year she has suffered from unexplained drops in blood pressure. She has never regained her energy level and is often sick with sinus infection like symptoms, but her sinuses are clear (x-ray) and no amount of antibiotics help. When she received the second Gardasil shot she also received the Menactra vaccine. 12/29/09 Pediatric Medical records received for DOS 01/02/08-01/05/10. PCP notified by school that pt. had first seizure activity on 01/18/08 and was transported by ambulance to hospital. DC home to f/u with neurologist, MRI and EEG. Reported instances of seizure activity on 12/30/08, 01/01/09 and 11/25/09. Referrals to allergist, cardiologist and neurologist." nonenone 12/29/09 PMH: Asthma; Allergic to Bactrim.No diagnosis to date. All tests are inconclusive for any problems. Clear EEGs. No heart problem. Never used any drugs. Always healthy until this. 12/29/09 Diagnostics: Normal MRI and EEG . Patient recovered.

HPV (GARDASIL) Side Effects Report #368250
HPV (GARDASIL) vaccine side effect was reported on 11/17/2009. Female patient, 19.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Fatigue, "dizziness, nausea and malaise for several weeks after first injection (May 2007); vomiting, diffuse joint pain, weakness, sleeping constantly after second injections (July 2007); bilateral petechial rash lasting for several months, fatigue, left sided tingling of arm and leg followed by face droop and drooling, headache lasting a few months, alopecia, and pain after her third injection (August 2007). Treated with pain medication, accupuncture, facet injections, radiofrequency rhizotomy procedures. 11/30/09 Medical records and discharge summary received for DOS 5/1-5/8 Final DX: Intractable headache and neck pain, nausea, vomiting, nausea S/P Gardasil # 1 dizzy, nausea, weakness, malaise weakness. Improved. Gardasil #2 increased vomiting, weakness, diffuse joint pain. Somnolence, fatigue. Gardasil #3 w/meningitis vaccine, constant sleeping, anemia, bil petechial rash on legs, ANA eleveated, borderline low thyroid, L side tingling, facial droop w/headache for 10 min intermittently. Alopecia. Pain clinic tx w/facet injections. 70% improved. Received additional facet injection and developed severe neck pain and headache. Nausea, vomiting. Could not get out of bed. Steroids, fluids. Much improved. D/C to home w/pain meds." PMH: depression Allergies: unk"Labs & Diags: Ct Head- no intracranial cause of headaches, Normal contrast MRA of the head, Normal CTA neck, ANA neg. ALT/SGPT 53 (H), ALBUMIN 3.4 (L), GLOBULIN 4.3 (H), MAGNESIUM, 14. (L), CA 8.1 (L), GLUC 125 (H), BUN 5 (L), SODIUM 130 (" . Patient was hospitalized Patient recovered.

HPV (GARDASIL) Side Effects Report #369649
HPV (GARDASIL) vaccine side effect was reported on 11/24/2009. Female patient, 25.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Fatigue, "sore throat, high fever followed by total body joint pain and swelling. treatment began with a prednisone shot 11/25/09 ED Notes for DOS 01/17/09. Final DX: Inflammatory arthritis, systemic symptoms of fever and fatigue, sore throat self-limiting, leukocytosis infcluding eosonophilia/neutrophilia, and microscopic hematuria. Pt presented to ED with 2 wk hx of joint pain, swelling and stiffness. The pain started in her hands and generalized to her jaw. Pt did not have fever, but had sore throat for 3 days, which went untreated. Pt noted that she was unable to form a fist. On 01/14/09, Pt was seen in urgent care and tests confirmed leukocytosis, elevated ESR, and hematuria. NSAIDs, Vicodin and prednisone did not resolve the arthralgias. Upon physical assessment, Pt was found to have a recent numbness, tingling of hands that resolved. Pt's physician suspected a diagnosis of possible adult onset of Still disease based on her symptoms, although the Pt did not meet all the criteria. Prednisone 20 mg/day was started. Pt scheduled for a follow up visit in 1 month. 11/25/09 Follow up visit notes for DOS 04/29/09. DX: Inflammatory arthritis, leukocytosis, thrombocytosis, recent microscopic hematuria. Pt complained of ongoing difficulties with wide spread joint pain and fatigue. Pt did not have visible swollen joints and prednisone was thought to have resolved this event. Physician reduced prednisone dose to 15 mg/day. Follow up visit was scheduled for 2 months. 11/25/09 Follow up visit notes for DOS 06/26/09. DX: Inflammatory arthritis and microscopic hematuria, indeterminant significance. Pt complained of uncontrolled pain and swollen joints of hands with morning stiffness that improves as the time goes on. Follow up visit scheduled for 2 months. 11/25/09 Follow up visit notes for DOS 07/02/09 DX: Hematuria. Pt felt better with no pain or swelling and wanted to be off prednisone. Follow up visit scheduled for 2 months. 11/25/09 Follow up visit notes for DOS 09/04/09 DX: Inflammatory polyarthritis" 11/25/09 PMH: Tonsillectomy11/25/09 Allergies: Erythromycin allergy or intolerance."diagnosed with stills disease an auto immune disease similar to rheumatoid arthritis 11/25/09 Laboratory tests showed WBC 17.9 with elevated neutrophils, eosonophils, monocyte count, hemoglobin 12.5, platelets 306 and ESR 48. 11/25/" . Patient recovered.

HPV (GARDASIL) Side Effects Report #370035
HPV (GARDASIL) vaccine side effect was reported on 11/24/2009. Female patient, 13.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Fatigue, "First administration of Gardasil in 07/08 with bilateral hand tremor beginning 08/08. Second administration on 12/31/08 with hand pain beginning 02/09 and extending to wrists, elbows, shoulders, back, hips, knees, ankles, feet and toes by 04/09. Final administration is 07/09 with immediate increase in pain. The physician was asked about possible reaction after the first dose. The physician advised there was no connection. Patient has been dx with fibromyalgia; however, no successful tx at this time. Along with the tremor, other neurological involvement is indicated by bilateral clonus and proprioceptive symptoms in her legs. Patient also suffers headache and significant fatigue. Patient has been unable to sleep in bed for several months and does not get solid, consecutive hours of sleep. She has lost 20 pounds since this past Spring. There are days patient requires moderate assistance for sit-to-stand. 12/04/09 Consult note for DOS 01/30/09. DX: Essential tremor Pt c/o hand tremor that is bothering when writing for 4-5 mos. On neurological exam: weight, head and height were all above 90th percentile; mild postural tremor BUE. Physician considered this diagnosis of essential tremor as benign and suggested reducing caffeine and stress. Pt to follow up prn. 12/08/09 Follow up consult for DOS 11/09/09. DX: Fibromyalgia Pt c/o L knee pain, neck pain, inguinal pain, finger joint pain, hand pain, wrist joint pain, elbow joint pain, shoulder joint pain, back pain in Lumbar spine, buttock pain, and hip. Musculoskeletal exam: confirmed joint pain in L fingers, shoulder, L and R knees, L and R ankles; tx: Soma. Pt c/o pain continuing." No"allergic to penicillin and seasonal allergies 12/08/09 Follow up consult for DOS 11/09/09. PMH: Hypothyroidism; Allergies: Amoxicillin, Zithromax, Augmentin.""I do not have specific results. They have completed blood work and x-rays that ruled out rheumatoid arthritis. Patient has also had an MRI of her pelvis. I was advised that all testing has been negative, but am not sure for which conditions" . Patient recovered.

HPV (GARDASIL) Side Effects Report #370139
HPV (GARDASIL) vaccine side effect was reported on 11/24/2009. Female patient, 16.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Fatigue, "Information has been received from a physician concerning a female ~sophomore in high school~ student patient who on an unspecified date was vaccinated with the first 0.5 mL GARDASIL and on unknown date received the second dose of GARDASIL. It was reported that the patient developed rash after getting two doses of GARDASIL. The patient sought unspecified medical attention. At the time of reporting the patient had not recovered. Follow up information has been received from a physician via medical records, concerning a 16 year old female student with allergy to DILAUDID, and a medical history of adenoidectomy, endotracheal intubation insertion, tonsillectomy, PE tubes and an orthopedic surgery (internal fixation of left arm fracture), who on 03-NOV-2008, was vaccinated with the first dose of GARDASIL (Lot No: 657737/0522U), in the left arm. On 20-JAN-2009. the patient was vaccinated with the second dose of GARDASIL (Lot No: 659437/1266U), in the left arm. Concomitant medications included doxycycline, TYLENOL and ZYRTEC. In February 2009, the patient experienced costochondritis. On 02-APR-2009, the patient presented for evaluation of one month of sickness with hives and then migrating joint pain. The patient presented with complaints of pain to all the joints and muscle pain. On of a scale of 10 the pain was 7. The severity of her fatigue on a scale of 10 was 7. The patient experienced morning stiffness duration 10 minutes. The physician reported that the patient stated that this condition started suddenly. The symptoms had been intermittently present for the last one month, with waves of hives and overall aching and now with recurrent erythema but without itching. The patient noted fevers as coming off the MEDROL and had sweats when on the steroids. The physical exam did not show any abnormality, except for the musculoskeletal exam that showed joints affected primarily in the ankle, and possible inflammation of the MTP. The skin exam showed scattered macules of the arms and more confluent itchy area of the skin on" Drug hypersensitivitySurgery; Arm fracture; Orthopedic procedure; Endotracheal intubation; Tympanostomy tube insertion; Tonsillectomy; Adenoidectomy"Serum creatine kinase, 05/06/09, Normal; Urinalysis, 04/02/09, Protein in urine; Erythrocyte, 05/06/09, elevated: 49" . During the same period patient was treated with TYLENOL; ZYRTEC; doxycycline. Patient recovered.

HPV (GARDASIL) Side Effects Report #370627
HPV (GARDASIL) vaccine side effect was reported on 11/25/2009. Female patient was vaccinated with HPV (GARDASIL). Patient symptoms: Fatigue, "Information has been received concerning a female patient ~maybe college-age~ with unspecified medical history, drug reactions or allergies, who in 2008 was vaccinated with a dose of GARDASIL (route and lot # unknown). Concomitant medication unspecified. On 17-NOV-2009, a news station reported that the patient reported that she received GARDASIL and on an unspecified date she became tired all of a sudden, she also suddenly developed lupus and her pancreas had to be taken out. She possibly might need chemotherapy in the future. Unspecified lab diagnostic studies performed. The patient sought unspecified medical attention. At the time of this report the patient had not recovered. Attempts are being made to verify the existence of an identifiable patient. No further information is available." unknownunknown . During the same period patient was treated with unknown. Patient recovered.

HPV (GARDASIL) Side Effects Report #371619
HPV (GARDASIL) vaccine side effect was reported on 12/04/2009. Female patient, 17.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Fatigue, "I am unsure of an accurate time, her new symptoms didnt start until after the second vaccine in the series of three. On 2/23/09 she was vaccinated and on 2/25 the symptoms started and have not gone away. Syncope several episodes, nausea, tunnel vision, muffled hearing, tingling limbs, dry mouth, burning sensations, overall ~weird feeling/somethings not right~ extreme fatigue, leg muscles contract or something and she cannot bend it until it stops." "no Time above is unknown, the system made me enter a time, the doctors office may have record of that""pineal cyst 12/29/09 PMH: allergy-Relpax, arachnoid cyst, pineal gland dysfunction, congental anomalies of inner ear (2005), syncope (01/26/09), common migraine.""EKG, ECG, MRI, CT Blood work, Seen by Neurologist who says her symptoms are not at all related to her Pineal Cyst, now they are asking we find a new doctor because she's 18, my thought is they don't know how to fix her so wash their hands o" . Patient recovered.

HPV (GARDASIL) Side Effects Report #373636
HPV (GARDASIL) vaccine side effect was reported on 12/10/2009. Female patient, 17.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Fatigue, This 18 year old female received the GARDASIL vaccine and 2 weeks later developed acute disseminated encephalomyelitis. Her initial symptoms were fever tachycardia and headache followed by ataxia. She was discharged and had a recurrence of her symptoms a month later which resolved over the following weeks. She has been left with persistent fatigue and intermittent tachycardia. Allergies PanMist SM SYRP. Active Problems Normal Routine History And Physical Adult -V70.0 - PMH Eczema -692.9. Family Hx No multiple sclerosis No stroke syndrome No paraplegia of unknown etiology No autoimmune disease. Personal Hx Behavioral history: Not smoking. Alcohol: Not using alcohol. Drug use: Not using drugs. Marital History - Single.She had a normal lumbar puncture and an abnormal MRI with two periventricular white matter lesions. . During the same period patient was treated with None. Patient was hospitalized Patient recovered.

HPV (GARDASIL) Side Effects Report #374741
HPV (GARDASIL) vaccine side effect was reported on 12/22/2009. Female patient, 22.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Fatigue, "My entire life I have been very active, worked out every day of my life since 15, never ever in my life had any sort of acne...no health problems. About a year ago everything changed, in the past year I have gained exactly 27 pounds and although I continue and try to workout I am unable to lose this weight...I am so fatigued to the point I cant get out of bed most days which has affected a few semesters of college and I have lost a few jobs due to this fatigue which I cannot control. I am unable to bend over and pick anything up without getting dizzy and any activity as simple as running up the stairs my heart speeds up and I am out of breath and need to sit. I have consistently had a minimum of 2 migraines a week in which I am unable to leave the house this has been for the past year, and prior to these migraines I have extreme back and neck pain which painkillers cannot even help. I have been to numerous dermatologists trying to resolve 2 issues, adult acne AND excessive facial hair growth on my jawline, chin and under chin to the point Ii just use a razor now to remove the hair as I am unable to afford full laser hair removal and insurance does not cover. My entire life I have had beautiful thick hair, in fact so thick I would get stopped by people with compliments however the past year I pull chucks of hair out in the shower and it is very thin and brittle now. I have done so much blood work and every test in the book. In the past year I have been to a heart doctor, dermatologists, chiropractors, endocrinologist, natural homeopathic doctor, and 3 different physicians and NO ONE has a solution...my mom has been very down as she is upset for me and with me we feel so lost nobody has any idea what is going on. The past year I have consistently described myself as ~this is not me and this is not my body~. I now get depressed as I have no control of the weight gain or acne or facial hair or hair loss or any of this. My numerous doctor visits and mental pain I have endured have left a hole in my family's w" nonenoneHave been tested for PCOS as I have all of the symptoms for it but 3 different doctors ran tests including an endocrinologist and it has been confirmed 3 times that I do not have PCOS. All of these symptoms have occurred exactly after my 1 . Patient was hospitalized Patient recovered.

HPV (GARDASIL) Side Effects Report #374854
HPV (GARDASIL) vaccine side effect was reported on 12/23/2009. Female patient, 25.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Fatigue, "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" No"No. 12/28/09 Discharge summary, hospital records received. Service dates 11/23/09 to 12/22/09. Asthma. Allergies to erythromycin, penicillin.""Thrombocytopenia. I have been now been admitted into the hospital 3 times, and have to go back again in a few days, as I have dropped again. My levels have been at 8,000, 3,000, and 12,000 (normal levels are 150,000 - 450,000) at the time" . During the same period patient was treated with Trivora Birth control (oral pill taken 1x per day) Albuterol inhaler (taken as needed for seasonal and pet allergies). Patient was hospitalized Patient recovered.

HPV (GARDASIL) Side Effects Report #374928
HPV (GARDASIL) vaccine side effect was reported on 12/22/2009. Female patient was vaccinated with HPV (GARDASIL). Patient symptoms: Fatigue, "Information has been received from a registered nurse, a Licensed Practical Nurse (LPN) and medical records for the Pregnancy Registry for GARDASIL, concerning a 17 year old female, gravida 1 Para 0, had chicken pox in the past, with no known drug allergies and with a history of depressive disorder of bipolar for which she was being treated with LEXAPRO (start date not reported) who on 17-AUG-2007 and 11-MAY-2009 was vaccinated with first dose (lot number 656051/0244U) and second dose (659184/0843X), respectively of GARDASIL, both doses were vaccinated in right deltoid IM. On 11-MAY-2009, the patient was also vaccinated with hepatitis A virus vaccine inactivated (MSD) (659832/0932) in left deltoid IM. Concomitant therapy included LEXAPRO and prenatal vitamin oral tablet 27-0.8mg, 1 tablet daily. On an unspecified date after the patient received the second dose of HPV vaccine, a PAP test was positive for HPV. On 16-SEP-2009, the patient presented with amenorrhea and positive home pregnancy test. The patient's LMP was on 01-JUN-2009 and the EDD was 08-MAR-2010. The father of baby (FOB). The patient had a paternal cousin with autism. FOB had a maternal uncle who was born with a diaphragm disorder and the ~heart on the wrong side~, the description was most suspicious for a congenital diaphragmatic hernia. It was also reported that the FOB's maternal great uncle had Down syndrome and with mental retardation. The patient's grandmother had breast cancer and her grandfather had diabetes and heart disease. After the patient discovered she was pregnant, she stopped taking LEXAPRO (stop date not reported). The patient had a body rash during her first trimester (no further details were provided). On 16-SEP-2009, her EGA was 15 weeks 2 days. Her cycles were regular and occurred approximately every 28 days. Her last pap smear, which was performed in 2007, showed normal, A urine pregnancy test was positive 3 weeks ago, which was on approximately 26-AUG-2009. Her last menstrual period was normal and lasted for 6 days. Since her" Bipolar disorder; Depressive disorder; SmokerChickenpox"Ultrasound, 09/16/09, suspected CNS abnormality of fetus and suspected fetal condition; Ultrasound, 09/17/09, fetus has misshapen skull with anterior and posterior bulging at the forehead; Ultrasound 10/08/2009, the right orbit did not ap" . During the same period patient was treated with LEXAPRO; Vitamins (unspecified). Patient recovered.

HPV (GARDASIL) Side Effects Report #375362
HPV (GARDASIL) vaccine side effect was reported on 12/28/2009. Female patient, 18.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Fatigue, "Information has been received from a physician concerning an 18 year old female patient with fatigue, depression and insomnia who was vaccinated with the first, second and third dose of GARDASIL on 06-AUG-2007, 06-NOV-2007 and 04-MAR-2008 respectively. Concomitant therapy included ZOLOFT, SEROQUEL and maybe CORTEF. The physician reported that after the third dose vaccination with GARDASIL, the patient experienced chronic fatigue and EPSTEIN-BARR syndrome. The physician also reported that about two weeks after the vaccination, on approximately 18-MAR-2008, the patient was diagnosed with EPSTEIN-BARR syndrome. Thyroid test( results not provided) and EPSTEIN BARR test were performed. The EPSTEIN-BARR test was positive. The patient sought medical attention in the office. It was reported that the patient was unable to attend her last semester of high school due to fatigue. At the time of the report the patient had not recovered. All telephone attempts to obtain follow-up information have been unsuccessful. The patient's chronic fatigue and EPSTEIN BARR syndrome were considered to be disabling by the physician. Additional information has been requested." Depression; Insomnia; Fatigue"thyroid function test, 03/??/08, results not provided; EPSTEIN-BARR virus, 03/18?/08, positive" . During the same period patient was treated with CORTEF; SEROQUEL; ZOLOFT. Patient recovered.


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