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Blood test 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:Blood test

HPV (GARDASIL) Side Effects Report #336390
HPV (GARDASIL) vaccine side effect was reported on 01/02/2009. Female patient, 18.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Blood test, "syncope or seizure still being determined,events started in june of 08, she has experienced over 100 syncope episodes since that time, a month or so after inoculation, co administered with Hep A, episodes began in june, again in august, september, weekly in november, december, has experienced immobility, nausea, irregular and missed periods, migraine like headaches, left ear pain, leg pain and tingling in hands and feet, lower back pain, to date she has been to the ER 7 times and had two hospital stays for issues of passing out from 3 minutes to over 30 minutes as she passes out repeatedly, no medical treatment other than rest up until this point, she is being admitted for further neurological understanding and a three day hospital evaluation. 2/4/09 Neurology consult received dated 12/22/08 for eval of episodic LOC. Pt initially began having lapses of consciousness in 6/2008 on vacation. Seen in ER and found to be dehydrated, possibly r/t alcohol consumption. Repeat attacks however were with good hydration status. 1 week after 1st episode pt was feeling ill and unable to walk/stand w/o having an episode. W/U (-). Pt may have weeks w/o episodes, but then begin with teeth chattering, then a ~head rush~, dizziness and the feeling of going to pass out. Holter monitor did not register any abnormalities during episodes. Episode in 8/2008, pt was unable to roused x 30 minutes. W/U (-). In 12/08 episode did not involve complete LOC but had bifrontal H/A with photophobia after. Some events involve hand shaking or whole body shaking. Pt to be admitted for further eval.D/C Summary received for DOS 1/5-8/2009 with D/C DX: Unexplained LOC. PE WNL. One mild event noted during admission with teeth chattering and tremulous movements of the upper extremities, L>R. No LOC. No further events during admission." nonenone PMH: frontal H/A. Low back pain x 1 yr."ekg, eeg, cat scan, mri, blood tests. Labs and Diagnostics: EKG WNL. EEG WNL. Normal imaging studies. Brain MRI WNL." . Patient was hospitalized Patient recovered.

HPV (GARDASIL) Side Effects Report #336933
HPV (GARDASIL) vaccine side effect was reported on 01/09/2009. Female patient, 26.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Blood test, "HAD THE SERIES OF 3 GARDISIL VACCINES, HAVE BEEN EXPERIENCING PAIN IN FEET, HANDS, THEN OTHER JOINTS, BEEN TO DOCTORS, JUST BEEN TOLD MAY HAVE RHEUMATOID ARTHRITIS!! AT AGE 28. THESE SYMPTOMS STARTED AFTER THE VACCINE,BUT HAVE WORSENED OVER LAS 9-12 MONTHS!! I THNIK IT IS FROM THIS VACCINE! WHAT CAN WE DO? DON'T WANT MY DAUGHTER TAKING RA MEDS IF SOMETHING ELSE CAN HELP!! 2/2/09 Rheumatology consult received for eval of joint pain dated 12/19/08. Pt initially c/o sore feet, particularly in MTP joints x 2 yrs. Hand pain x 1 yr. Recent hand swelling jaw pain, and R shoulder, elbow and wrist pain with morning stiffness x 30 minutes. (+) canker sores and fever blisters. PE (+) for L posterior cervical lymph node, decreased thumb flexion, joint tenderness, synovitis, and swelling. Presntation c/w inflammatory arthritis such as RA." NONENONE. PMH: 30 lb wt loss 2' to stress"BLOOD WORK, XRAYS AT UVA, FONTAINE RESEARCH CENTER. Labs and Diagnostics: Anti-CCP (+), CRP 1.0. X-rays (+) for osteophytosis of the R foot, otherwise WNL. Complement CH 50 (H) at 386. UA (+) for 14 WBCs and few bacteria. ANA (+) at 1:640" . 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: Blood test, "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 #337625
HPV (GARDASIL) vaccine side effect was reported on 01/18/2009. Female patient, 19.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Blood test, "Immediately after receiving shot,severe pain in injection arm.Had to rest for 10mins in office.Beginning the next day, had a painful knot in back, pain in left lung if deep breath is drawn, muscle weakness on left side from shoulder to fingertips all the way down to toes, muscle weakness, nausea, headache,rash on neck and itchiness on chest.These symptoms progressed and got worse and by Friday. Call Dr's office. Was told the symptoms I described had nothing to do with the Gardasil Shot. After I pressed the issue, the doctor returned my call, stated their office could do nothing and suggested I should see my primary care physician. The primary care doctor was booked solid so went to urgent care center. The doctor on duty did not know much about gardasil and suggested we go to the emergency room at another hospital if symptoms got worse. I took my daughter home and watched over her. She did begin to feel better and as of today the symptoms have subsided. This was her 2nd gardasil shot, the first was given 7/2008. She is scheduled to receive the 3rd shot on 2/3/2009. I am very afraid to have the 3rd shot administered because of the difficulty she experienced with the 2nd shot and the lack of support she received from her doctor and the urgent care doctor." nonenoneA blood test was done at the urgent care office for any abnormality and results were okay. . During the same period patient was treated with yaz birth control. Patient recovered.

HPV (GARDASIL) Side Effects Report #337711
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: Blood test, "I believe the symptoms started after the second dose. Delainey has been having fainting spells where she gets dizzy and sees black with white spots and she loses her balance. It only lasts a few seconds. It has happened at least 25 times or more. 2/23/09 PCP rec received for OV 12/15/08 with c/o black-out episodes x several months. Sees ~spots~ then blacks out. Reported loses vision x 4-5 seconds with slow return. PE WNL. Sent for labs and testing." nonenone"Her pediatrician has checked her vital signs, sent her for blood work, did an ultrasound on her heart, and a CT scan. All came back normal. Labs and Diagnostics: ECG WNL. Creatinine (L) 0.7. Head CT (-)." . During the same period patient was treated with Motrin as needed. Patient recovered.

HPV (GARDASIL) Side Effects Report #338661
HPV (GARDASIL) vaccine side effect was reported on 01/16/2009. Female patient, 15.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Blood test, "Information has been received from a physician concerning a 15 year old female patient with no pertinent medical history, no drug reactions/allergies; who on 17-JUL-2008 was vaccinated with the second dose of GARDASIL. There was no concomitant medication. On 05-SEP-2008, about 5 weeks after vaccination, the patient developed hallucinations, both visual and auditory. The patient had also had syncope. The patient was seen in the office and was treated with KEPPRA with no effect. In the beginning of December 2008, the patient had recovered. Follow up information has been received from a physician on 20-FEB-2009. It was reported that the 15 year old female patient had hallucinations. On approximately February 2009 the patient had recovered.Additional information is not expected." None"Magnetic resonance; diagnostic laboratory, blood tests; electroencephalography; cerebrospinal fluid" . During the same period patient was treated with None. 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: Blood test, "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 #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: Blood test, "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 #338762
HPV (GARDASIL) vaccine side effect was reported on 01/29/2009. Female patient, 20.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Blood test, "I got the first HPV vaccine, and 1 hr later, I developed a fever of 102.0, was vomiting, and had a severe headache. Ever since 9/20/07, I have had a chronic, 24 hr/day headache. I have seen my PCP, neurologist, and many ER visits. It has been concluded that this occurred from the HPV vaccine. After doing extensive research about GARDASIL, and being advised by healthcare professionals, I got the first dose on 9/20/2007. About an hr later, I got a fever of 102.2, was vomiting, and had a severe headache. Eventually, the other symptoms went away, but the headache continued. It was an intense headache that lasted 24hrs/a day. I saw my PCP several times, and was referred to a neurologist. In the meantime, I got the second dose on 11/14/2007. I did not put two and two together. Since there was a long wait to see the neurologist, I ended up in the emergency room twice in 12/07. The first visit, an MRI, CT, and Lumbar Puncture were performed. I ended back in the ER a few days later for observation. All of the tests came back normal, but the pain was unbearable. I was put on IV MORPHINE, which had little affect. I then got an urgent appt with my neurologist in 12/07. Since 9/07, my life has been turned upside down. I have missed work, had to switch jobs, and have struggled to finish nursing school. I was 100 percent healthy before this immunization I have spent thousands of dollars on medications, copays, alternative options, such as chiropractic care, acupuncture, and massage. I simply can't afford it. I have been on more Rx in the last year and a half than most people have in a lifetime. At 21 years old, I should be able to live a normal life. Within the past month, I have been back in the ER three times. The only thing that ~took the edge off~ was IV DILAUDID. I have tried basic OTC such as ADVIL, TYLENOL, ALEVE, EXCEDRIN, Rx NSAIDS, PREDNISONE, muscle relaxers, anticonvulsants, and tricyclic antidepressants. Caffeine and antihistamine, narcotics, and just about anything else you can of, I have tried. Still, nothing has" NoneNone"Several tests, including extensive blood work; Cat Scan; MRI; and Lumbar puncture. 2/17/09-records received-CSF pressure 120-130, protein 31.2 and glucose 61, cutlure negative. CBC showed elevated WBC 10,300. Urinalysis revealed 1+ protein" . During the same period patient was treated with "At the time, just oral contraceptives 2/17/09-records received-Current medications Necon and Lorazepam.". 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: Blood test, "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: Blood test, "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: Blood test, "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 #339581
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: Blood test, "1st Gardasil vaccination on 2/19/08. Second Gardasil vaccination April 2008. 3 weeks later, on May 9, she came home from school complaining of soreness in all her joints. She had no fever or any other flu-like symptoms. Medical tests have consistently been negative for arthritis, lupus or any other autoimmune disease the doctors could think of. Neurological tests revealed no neurological source of the soreness and stiffness. Nine months later, she is still experiencing joint pain. 2/20/09 MR received from PCP. In for 14 yr WCC on 2/19/08 with dx: Well adolescent. Next OV 5/9/08 with c/o joint pain and swelling x 2 days. PE (+) for swollen ankles. Dx: arthralgia. Returned 5/12/08 with increasing pain and swelling jaws, neck, knees, wrists and ankles. Tingling in feet. NSAIDS not helping. Swollen joints on PE with decreased strength- 4/5 ankles, knees and wrists. Labs WNL. Medrol rx with some improvement, with return of pain/stiffness after. Walking stiff legged 5/16/08. 2/27/09 MR received from neurologist dated 6/25/08 with DX: Pain, joint, musculotendonous, connective tissue. Etiology unknown. MR received from rheumatologist dated 12/9/08 and 2/3/09 with DX: Enthesitis related JIA and Fibromyalgia temporally associated with Gardasil vaccine. Another consult noted discusses amplified musculoskeletal pain syndrome. ? idiopathic variant of stiffman syndrome. Pt reports continued stiffness, joint pain and decreased mobility. More fatigue. Restarted Methotrexate and Humira 2/3/09" NONENONE. PMH: none noted. allergy to PCN"MRIs, Bone Scan, X-Rays, Echocardiogram, Bloodwork. Labs: CRP, ESR, ANA, RF, mono, Complement C3 and C4 all (-). Labs: EMG/NCS WNL. MRI brain WNL. MRI spine (-)." . During the same period patient was treated with NONE. Patient recovered.

HPV (GARDASIL) Side Effects Report #339854
HPV (GARDASIL) vaccine side effect was reported on 02/18/2009. Female patient, 19.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Blood test, "3rd in the series of Guardasil on 7/24/2008. On 9/10/2008, patient went to emergency room in ambulance due to rash and difficulty breathing, assumed allergic reaction to something. On 9/20/2008, patient had 2nd reaction with severe hives, shaking, jerking spasms and dehydration, assumed allergic reaction. Both times treatment was IV benedryl and prednazone pack. Allergist consultation visit the following day resulting in his prescribing use of over the counter allergy meds; Claritin in the AM, Pepsid mid day, Zyrtec at bedtime, benedryl as needed. 9/25/2008 patient was asleep and woke up choking with extreme breathing difficulties, resulting in another ambulance ride and a 3rd emergency room visit. Treatment was IV benedryl and Prednazone pack. Over the next 5 months several (5-7) cases of mild to moderate hives during which patient took over the counter benedryl and hives went away. On 2/09/2008, patient had severe abdominal pain, began having difficulty breathing and noted hives. This resulted in 3rd ambulance ride to emergency room. For 5 months, patient has taken over the counter allergy meds regularly as described above. Up to this point in her life she has had no known allergies, no anaphylaxis and has been in very good health, active in sports. During this 5 months, she has been to the emergency room 4 times, 3 of those with severe breathing difficulties. Symptoms include hives, abdominal pain, swelling of hands and fingers, difficulty breathing all occurring rapidly. This is considered to be a life threatening situation. It appears that this response could have been caused by Guardasil injection from 7/24/2008. 3/17/09-received office records for date of vaccine. Well visit. krk 4/6/09-records received-ED visit 9/O itching and diffuse swelling, facel feels swollen. PE:eyelids slightly swollen. DX:acute allergic reacion. acute allergic rash. ED visit 9/20/08-C/O allergic reaction, ithcy urticarial rash suddenly with some shortness of breath. Previous episodes of urtic" nonenone 4/13/09-records received- PMH:seasonal allergies.allergist has performed general bloodwork 4/13/09-records received-Skin testing positive. . Patient recovered.

HPV (GARDASIL) Side Effects Report #340733
HPV (GARDASIL) vaccine side effect was reported on 02/13/2009. Female patient, 15.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Blood test, "Information has been received from a doctor of pharmacist concerning a 17 year old female patient with no pertinent medical history and no known drug allergies/drug reactions, who completed her GARDASIL vaccine series ~sometime~ last year. Concomitant therapy included hormonal contraceptives (unspecified) and vitamins (unspecified). It was reported that about a month after completion of the series the patient began to develop ~stabbing left hemisphere head pain and numbness to the left arm and leg. It was reported that the patient has continued to have biweekly ~attacks~ since the beginning of symptoms. At the time of reporting the patient had a blood work, head computed axial tomography and an magnetic resonance imaging of head done. All results were negative. At the time of the report the patient had not recovered. The patient sought medical attention with the neurologist. Additional information has been requested. Follow-up information received from the physician's office who reported that the 16-year-old female patient (previously reported at 17 years old) was experiencing headaches prior to receving the third dose of GARDASIL given in October 2008 (previously re ported as 2009, month unknown). Onset date of headaches and hypaesthesia was reported as November 2008 dose. The patient was seen by neurologist in late December/ early January and was diagnosed with migranines. The patient was not hospitalized and is currently doing fine. No further information is available. 3/16/09 Received Neuro medical records of 1/8-2/18/2009. FINAL DX: probable basilar migraine Records reveal patient experienced four spells of unconsciousness, pallor, slurred speech over several weeks preceded by blurred vision & seeing spots. Has had frequent dizziness, right parietal pain, contralateral arm & leg tingling. Referred for MRI & tx w/meds. RTC 2/18 w/good response to meds." "None PMH: Overweight, appendectomy & cholecystectomy, 12yo. LOC w/possible seizure, 11yo. Family hx: migraines""diagnostic laboratory - negative; head computed axial - negative; magnetic resonance - negative LABS: Echocardiogram, EKG, EEG done 11yo all WNL." . During the same period patient was treated with "hormonal contraceptives, vitamins (unspecified)". Patient recovered.

HPV (GARDASIL) Side Effects Report #340119
HPV (GARDASIL) vaccine side effect was reported on 02/19/2009. Female patient, 16.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Blood test, "Two weeks before Thanksgiving, mother says patient had cold symptoms, coughing and nasal congestion. The week of Thanksgiving, Nov. 24, 2008, patient c/o difficulty breathing, chest pains and a headache. To hospital emergency room. Patient was admitted and hospitalized two days in ICU and three days on the hematology unit according to mother. Diagnosis, Pulmonary Embolism. Another emergency visit to hospital on Feb. 13, 2009 for symptoms of diarrhea and bloody stools. 2/25/09-records received for DOS 11/24-11/28/08-DC DX: Pulmonary embolism. Presented with increasing shortness of breath, worsening cough anc chest wall pain for 2 weeks. Seen in Ed 1 week prior with shortness of breath and CXR determined to be asthma." "Mother says two weeks before Thanksgiving, patient had cold symptoms, coughing and nasal congestion."Hx. of anxiety and four years ago diagnosed having Thrombophilia per mother. 2/25/09-records received-PMH: MTHFR mutation."Chest X-ray, venous blood draws, CAT Scan, Nuclear contrast test, and many other tests but mother can not remember. 2/25/09-records received- On admission CXR revealed incrased perihilar markings and CT chest angiogram showed decreased att" . During the same period patient was treated with "Levenox, two injections daily for three weeks then discontinued, Coumadin daily, Seroquel 100 mg. one daily". 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: Blood test, "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 #341419
HPV (GARDASIL) vaccine side effect was reported on 02/12/2009. Female patient, child 12.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Blood test, "8/1/08- 1st shot- fainting began, headaches. 10/2/08-2nd shot- fainting + headaches continue inability to sleep or concentrate, inability to see or have use of her legs during fainting, sensitive nerves. 5/18/09 hospital records received DOS 3/5/09 to 3/6/09. FINAL DIAGNOSIS: Migraine - non-classic type, urinary tract infection Post vaccination: light headedness, feels that she will fall over, floating in lower extremities, and tunnel vision. Later insomnia, syncope on standing, fell backwards with stiffening in legs. 4/5 strenght L upper extremity. Urinary tract infection. 5/18/09 medical records received - includes neuro consult - DOS 12/1/08 to 4/8/09. FINAL DIAGNOSIS: Seizures presented as syncope Post vaccination: with change of position sees dark spots. Fell backwards with episode of rigidity. Weight loss, lower abdominal pain. Acne forehead, cheeks, chin, chest. URI with cough, congestion, rhinorrhea, hoarse, sore throat, chest heavy, difficulty taking deep breaths. Neurology consult - headaches, stress, people picking on me," NoneAsthma"MRI; EEG; Heart monitor; Blood work. 5/18/09 hospital records received DOS 3/5/09 to 3/6/09. LABS and DIAGNOSTICS: Urinalysis - hazy, protein trace, leukocyte esterase, WBC 2, RBC 1, bacteria moderate, squamous epithelial cells 5, tr" . During the same period patient was treated with "None 5/18/09 medical records received DOS 12/1/08 to 4/8/09. benzaclin, albuterol, Pediazole". Patient recovered.

HPV (GARDASIL) Side Effects Report #342765
HPV (GARDASIL) vaccine side effect was reported on 03/13/2009. Female patient, 23.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Blood test, "Initial and follow-up information has been received from a nurse, for the Pregnancy Registry for GARDASIL, concerning a 23 year old female smoker with a history of one pregnancy which the infant had gastroschisis and was pre-term premature rupture of fetal membranes at 32 weeks and pre-term delivery. On 19-MAY-2008 the patient was vaccinated intramuscularly with the first 0.5 ml dose of GARDASIL (lot no. 659182/1757U) into the right deltoid. There was no concomitant medication. The patient is now pregnant. On 18-JUN-2008 the patient had ultrasound done for dating and the result was normal embryo. On an unspecified date the patient had routine blood and laboratory tests done and no results reported. No problems reported. The patient sought unspecified medical attention. Follow-up information has been received from a complete pregnancy questionnaire. The patient was taking prenatal vitamin, 1 tablet daily in the entire pregnancy. On approximately 15-SEP-2008 the patient developed bacterial vaginosis. On 15-SEP-2008, the patient was prescribed metronidazole, 500 mg, twice a day for 7 days for the treatment of bacterial vaginosis on 15-SEP-2008, the patient developed chlamydia. On 16-SEP-2008, the patient was prescribed ZITHROMAX, 1 gram once for the treatment of chlamydia. On an unspecified date, the patient developed Group B streptococcal infection. The outcome of the events was unknown. On 07-FEB-2009, the patient delivered a normal baby girl with no congenital anomalies for complications at the 40 weeks gestation. The baby weighted 7 pounds and 4 ounces. The length was 21 inches (53.3 cm). The Apgar score was 8/9 and the head circumference was 33.5 cm. It was reported that there was no complication during pregnancy and delivery. Additional information is not expected." Pregnancy NOS (LMP = 5/2/2008); SmokerPremature labor; Premature rupture of membranes"ultrasound, 06/18/08, normal embryo" . During the same period patient was treated with vitamins (unspecified). Patient recovered.

HPV (GARDASIL) Side Effects Report #342108
HPV (GARDASIL) vaccine side effect was reported on 03/14/2009. Female patient, 18.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Blood test, "Feb-2-09 at 3:00 pm vaccines were given Within 5 minutes of vaccines, she was feeling nauseated and a numbness in right arm which started to spread to whole body, then was feeling shortness of breath and feeling very agitated. I took her back to the same nurse whom gave her the shots and she had my daughter lay down for about 15 minutes and while laying down my daughter started to have episode of feeling ill the nurse told her to lay down for 15 more minutes and then told her she was fine to go home." None was very healthy and happy until vaccines was givenNo"When taken to hospital on Feb-3-09 doctor took blood work and stated there were all the electrolism found, which was probably causing the pain in her legs" . During the same period patient was treated with No. Patient recovered.

HPV (GARDASIL) Side Effects Report #342178
HPV (GARDASIL) vaccine side effect was reported on 03/19/2009. Female patient, 20.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Blood test, "UTI like symptoms, frequent urination, burning on urination beginning 11 days after initial dose, continuing sporadically to present time, 9 months later. Treated twice with Macrobid, once with Augmentin. Also treated in March 09 for yeast infection. Persistant headache, vertigo, blurry vision incapacitating, beginning two months after second dose and continuing for another two months. During these months also experienced anxiety/panic attacks/depression, diarrhea, vomiting. Blood and urine tests all normal. MRI and CT scan revealed nothing. Pap test revealed abnormal cells at the moderate level. All symptoms were beginning to improve when the last dose was given because no one had yet connected the dots....Then exactly two months after the last dose all symptoms returned in full. Headache, blurry vision, vertigo, frequent and burning urination. Patient is now 3 months from the last dose of gardasil and is now starting to feel less bad!" nonenone"Blood, urine, MRI, CT scan all normal. Pap test taken six months after initial dose revealed abnormal cells in moderate range." . During the same period patient was treated with generic ortho-tri-cyclen. Patient recovered.

HPV (GARDASIL) Side Effects Report #342324
HPV (GARDASIL) vaccine side effect was reported on 03/21/2009. Female patient, 16.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Blood test, "Shortly after first shot, daughter started having weakness/tingling in left arm. Also, dizziness. Within a week after second shot, she began to have more weakness in both legs, tingling in both legs and left arm. Dizziness is worse. She feels very weak all over and doesnt feel like doing much. 3/23/09 Received PCP medical records of 1/9-3/9/2009. FINAL DX: migraine classical Records reveal patient was new patient on 1/9/09 & reported chronic vaginal infection x 2 yrs & HAw/photophobia & nausea. Examination revealed condyloma. Received HPV #1 & Menactra. Also tx w/oral BCP & verapamil for HA. RTC 3/9/09 for HPV #2. 5/12/09 Case closed as incomplete. Will reopen should additional information documenting high ASO titre & diagnosis of rheumatic fever as verbally reported by PCP become available." NoneNone PMH: GC & chlamydia vaginal infections 11/08. Family hx: migraines."Emergency Room visit on March 20, 2009. Blood work and CT scan were performed. All tests came back inconclusive/negative. Dr. recommended not to get third round of vaccine for HPV." . 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: Blood test, "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 #342520
HPV (GARDASIL) vaccine side effect was reported on 03/24/2009. Female patient, 14.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Blood test, "Patient received her first shot 5/24/07 - she had soreness in her arm and headaches but tollerated them. On 10/1/2007 patient was at basketball practice and collasped on the gym floor with severe abdominal pain and chest pain. The abdominal pains remained. In March 2008 she began vomiting bile and the abdominal pains worsened. They continued to get worse and in June 08 she had her second shot. Again, her pain increased. She got her 3rd shot in September 2008. We were at the hospital 4 days after her 3rd shot with adominal pain, high pulse, low blood pressure, and chest pain. By December patient was beginning to have seizure like episodes of staring and not breathing for 30-45 seconds at a time. She was beginning to have lower back pain as well as the abdominal pain and chest pain. She began to complain of burning in her stomach - like it was on fire. She had a tingling sensation in her legs and her feet - complaining of them being on fire, but her feet were freezing cold when I would touch them. Patient had a few urinary track infections and several bouts with dehydration. She also had blood in her stool. She became very weak and has only been to school 4 full days since November 2008. Patient was on numerous types of medicine but nothing seemed to help because of these episodes. Everyime she would eat it would make it worse and would be especially more intense during her monthly cycle. She was on a feeding tube for over 3 weeks as well as hospitalized 3 different times. We have been to the ER over 13 times. Records received - 05/01/2009 - multiple ED visits and hospital admissions 10/04/2008 to 02/10/2009. Prior psych hx of ADHD, LD, anxiety reaction. GI hx chronic functional dyspepsia.ED evaluations for nausea, vomiting, abdominal pain. Diagnoses have included GERD, functional abdominal pain, biliary diskinesia, pancreatitis, pancreatic divisum.GI, med imaging, and psych consultations.Sugical procedures have included cholecystectomy, ERCP, MRCP, feeding tube. Diagnosis: Chronic generalized abdominal pain of" It is hard to tell which vaccine was the most damaging but I can tell you patient received her first shot 5/24/07 Lot #0186U (riADHD - beginning 2006 5/7/09-records received-PMH: ADHD."Extensive Blood work up, Lactose intolerance test, Allergy testing, CT scans of abdomen and pelvis, Upper GI, 3 EKG tests, MRI on her brain, EGD test, Colonoscopy, Several abdominal ultra sounds, Gastro emptying, hyda scan, gallbladder remo" . During the same period patient was treated with Foclin XR20 - discontinued November 2008 due do pain medicine (no school attendance) no need for focusing. Patient was hospitalized 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: Blood test, "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 #343340
HPV (GARDASIL) vaccine side effect was reported . Female patient, 23.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Blood test, "Facial palsy (R). Pt states a few hours after vaccine she noticed drooping on right side of face - hospitalized. Referral to neurologist. Not resolved at visit on 4/1/09. 4/13/09 Received hospital medical records of 3/24-3/27/09. FINAL DX: no d/c summary dictated; neuro consult states right facial palsy Records reveal patient experienced left side facial & tongue numbness & pain, right mastoid pain, taste alteration, blurry vision, bifrontal HA, left side rib pain, left arm & leg pain w/weakness x 1 day. Neuro consult done. Exam revealed peripheral right seventh nerve distribution weakness w/weakness of right upper & lower face including weakness of right eye closure & widened right palpebral fissure; diminished pin/light touch left face, arm & leg; questionable give way weakness of left arm/leg. Admitted for observation & additional w/u to r/o brain stem lesion. Tx w/ASA. Recommended MRI/MRA but no report included." NoneNone Family hx: stroke & DM.MRI; Bloodwork LABS: Lymphocytes 46.2%(H). Anion gap 5.0(L). CT head WNL. . 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: Blood test, "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 #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: Blood test, "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 #344094
HPV (GARDASIL) vaccine side effect was reported on 04/13/2009. Female patient, 13.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Blood test, "Client recieved four vaccines on 4/2/09. The client parent requested all vaccine be given in the same extremity due to a previous injury in the other arm and the client fear of being unable to walk if we used the lower extremities. The parent reports that the Right arm was swollen and became very red and sore on 4/4/09. The client also had reported a headache which began on that date and a low grade fever. Her mother treated her with Motrin. On 4/6/09 the mother called to report that the client began vomiting the night before and that her arm was still swollen but not warm to touch and appered to be improving. The mother was advised to take her daughter to her doctor to be evaluated. The client's mother was contacted on 4/8/09 and informed that the client had been admitted to Hospital. On 4/13 futher follow up revealed that the client was home and has been diagnosed with parietal epliepsy. 4/16/09 MR received for DOS 4/8-10/2009 with D/C DX: Morbid Obesity. Pseudotumor Cerebri. Abnormal EEG. Pt initially presented to PCP with c/o dizziness upon standing, one episode of nausea and vomiting, and worsening of chronic H/A (~9 month hx). Pt recently fell out of a chair but did not have LOC. Pt sent to local hospital and transferred to current facility for neuro w/u. Started on Topamax after abnormal EEG. Pt still reporting mild dizziness and H/A at d/c." NoneNone Known PMH: Chronic H/A x 9 months. Bells Palsy 7/2008. Mono 2009. Strep throat. RADBlood work and a spinal tap were performed in the hospital. Labs and Diagnostics: MRI brain WNL except maxillary sinusitis. CSF WNL except increased opening pressure. EEG abnormal. . During the same period patient was treated with None Known.. Patient was hospitalized Patient recovered.

HPV (GARDASIL) Side Effects Report #344160
HPV (GARDASIL) vaccine side effect was reported on 04/14/2009. Female patient, child 11.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Blood test, "Information has been received from a physician concerning an 11 year old female who on 30-MAR-2009 (last week) was vaccinated with the first dose of GARDASIL. Concomitant therapy included VAQTA, MENACTRA and DTAP (unspecified) on the same day. Patient complained about sore throat a week prior to vaccination. A week later some kind test was performed and it showed that a group A strep in the blood was found. On approximately 30-MAR-2009, after getting the first dose of GARDASIL the patient experienced fever and pain in the hip after getting the vaccine. The patient died on 03-APR-2009. The patient sought unspecified medical attention. Additional information has been requested. 4/24/09 ER record received for DOS 4/1/09 with dx: Fever. Pediatric Viral syndrome. Pt presented with L hip pain and fever. PE (+) for tenderness over L anterior thigh. Tx with analgesic and d/c. 4/24/09 ER record received for DOS 4/3/09 with dx: Post-vaccination reaction. Pt presented again to ER with fever of 102'F, body aches, inability to walk 2' to leg pain, nausea, vomiting, rash and polymyagias. PE (+) for extremity pain and swelling, rash, as well as not sleeping and acting differently. Transferred to higher level of care. 4/24/09 MR received for DOS 4/3-4/2009 with Final DX: Necrotizing fasciitis (gram (+) cocci with septic shock). Pt expired 4/4/09. Pt admitted from local facility for eval of fever with difficulty ambulating. Neuro/ortho consults on arrival with probable dx: infectious myositis. Tx with IV abx however IV access was lost and pt became hypotensive and with eveidence of septic shock with cardiovascular instability. Pt intubated and despite extensive resuscitation efforts pt expired. 4/24/09 Autopsy report received with COD: Necrotizing Fasciitis (Gram (+)) with septic shock." "sore throat 4/24/09 PCP records received which reveal 11yr WCC 3/31/09 with no medical c/o. Vax given- Hep A, Gardasil, TDaP a"PMH: foot swelling. Sickle-cell trait."diagnostic laboratory, a group A strep in the blood was found. Labs 4/1/09: CBC with WBCs 11.1 73% segs, 13.1% lymphs, 12.6% monos. UA WNL Labs 4/3/09: CK 116. LDH 389. Na+ 131. K 3.1. Cl 94. CO2 18.6. Anion gap 21.5. Glucose 170. Albu" . Patient died on 3//09/04/0.

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: Blood test, "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 #345284
HPV (GARDASIL) vaccine side effect was reported on 04/14/2009. Female patient was vaccinated with HPV (GARDASIL). Patient symptoms: Blood test, "Information has been received from a physician concerning a female patient with a history of urinary tract infection who in the last couple of weeks was vaccinated with GARDASIL. Fairly recently, the patient presented with high fever and some gastrointestinal issues after receiving GARDASIL. A blood work was performed with unknown results. The patient's outcome was not reported. Additional information has been requested." Urinary tract infectionUnknown . During the same period patient was treated with Unknown. 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: Blood test, "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 #344590
HPV (GARDASIL) vaccine side effect was reported on 04/17/2009. Female patient, child 12.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Blood test, "Patient was given Hep A 1st, then HPV. After HPV was administered pt tensed up and began to loose her color, she then began to lean backwards and started to have a seizure. Seizure only lasted for 10 seconds. Vasovagal Syncope." NoneNoneEKG; O2 Saturation; BP; Blood sugar . 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: Blood test, "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: Blood test, "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 #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: Blood test, "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 #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: Blood test, "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 #345407
HPV (GARDASIL) vaccine side effect was reported on 05/01/2009. Female patient, child 11.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Blood test, "Vomiting, indegestion, lack of appetite, weightloss, dizziness, abdominal pain, fever, fainting, listlessness and nausea. This lasted from date of vaccine in January until end of March.She went to the Pediatrician three times, the Pediatric Gastroenteroligist, a Chiropractor and a surgeon. She underwent two blood tests, had a stool sample, an ultrasound and a Endosopy with no results found. She took several anti nausea vmiting medicines, took over the counter medications for her nausea and indigestion. 5/5/05 Records received DOS 1/7/09 to 3/7/09. Includes immunization records. FINAL DIAGNOSIS: Post vaccination: Flu-like symptoms, fever, chills, nausea and vomiting. Diarrhea. Later developed epigastric pain. Foul smelling flatus. LABS: MCV low, Abdominal Ultrasound WNL 5/11/09 Gastroenterology records received DOS 2/9/09 to 2/19/09. FINAL DIAGNOSIS: Abdominal pain, nausea, vomiting Post vaccination: Flu-like symptoms, fever, chills, nausea and vomiting which subsided, followed one week later with recurrence of nausea, and development of epigastric abdominal pain, diarrhea. Progressed to persistant vomiting, epigastric pain, and severe nausea. Frequent foul smelling flatus." None"Lactose intolerance, nocternal enuresis, hypothyroidism""Ultrasound, Endoscopy, Blood tests and stool sample 5/5/05 Records received DOS 1/7/09 to 3/7/09. LABS: MCV low, Abdominal Ultrasound WNL 5/11/09 Gastroenterology records received DOS 2/9/09 to 2/19/09. LABS and DIAGNOSTICS: Endoscopy" . During the same period patient was treated with None. 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: Blood test, "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 #346800
HPV (GARDASIL) vaccine side effect was reported on 05/14/2009. Female patient, 17.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Blood test, "Information has been received from a consumer concerning her daughter, a 17 year old female patient with no relevant medical history, drug reaction or allergies, who on 10-MAR-2009 was vaccinated IM with her first 0.5 ml dose of GARDASIL (lot number and site not reported). On 27-MAR-2009, the patient was vaccinated IM with her second 0.5 ml dose of GARDASIL (lot number and site not reported). There was no adverse event after the first dose. It was reported that the patient developed ~flu like symptoms and migraines~ which was diagnosed with bronchitis. The patient was brought to the hospital but not admitted after getting her second dose. Unspecified blood work was performed on an unspecified date with no result reported. The patient's mother stated that the patient was feeling better and the migraines stopped ~2 or 3 days ago.~ The patient had sought an unspecified medical attention. No further information is available." NoneUnknown . During the same period patient was treated with None. 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: Blood test, "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 #348870
HPV (GARDASIL) vaccine side effect was reported on 06/10/2009. Female patient, 17.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Blood test, "Rash beginning on bilateral arms. On and off x 1 wk. Rash down bilateral legs and cont. on arms x 3-4 days. Began with rash to face and neck 6-8-09 comes and goes. Rash seized yesterday began again today. 7/24/09 ER records received DOS 6/3/09 and 6/22/09. Assessment: Hives/Urticaria. Hypokalemia, bulemia. Patient presents on 6/3/09 with an itchy urticarial rash on arms, legs and trunk, of one month duration. On 6/22/09 c/o syncope X2, feels weak, falling. Lightheadedness, trouble with vision. Collapsed." "7/24/09 ER records received DOS 6/3/09 and 6/22/09. Chicken pox. Bulemia, depression.""Immunocap. 7/24/09 ER records received DOS 6/3/09 and 6/22/09. LABS and DIAGNOSTICS: CHEM - Postassium 2.7 mmol/L (L). CBC - MCH 31.5 PG (H). Urinalysis - pH 9.0 (H), Protein trace, Bacteria 3+, Mucous trace, Amorph Phos 2+. Last time p" . During the same period patient was treated with None. Patient was hospitalized 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: Blood test, "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 #349805
HPV (GARDASIL) vaccine side effect was reported on 06/22/2009. Female patient, 21.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Blood test, "Information has been received from a 21 year old female patient with a history of previous miscarriage and anaemia who in February 2009, was vaccinated with the first dose of GARDASIL (lot# not available). There was no concomitant medication. The Health Department that administered the vaccine did a pregnancy test but it came back negative. The patient thinks she may have been about 2 weeks pregnant at the time of the injection. On 07-MAY-2009 the patient had a miscarriage and the physician also discovered she had an anemia. A blood test and ~D & C~ (unspecified) were performed (no results provided). The patient sought unspecified medical attention. Upon internal review miscarriage was considered to be another important medical event. No further information is available." Miscarriage; Anaemia"beta-human chorionic, result negative" . During the same period patient was treated with None. Patient recovered.

HPV (GARDASIL) Side Effects Report #349853
HPV (GARDASIL) vaccine side effect was reported on 06/23/2009. Female patient, 18.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Blood test, "Swelling of both ankles, purple/red color on heals. Extreme pain in left ankle/ achillies tenden/ lower leg. Began December 08- Present. Can not stand or put pressure on left foot without pain. Gardasil Dose #1 9/20/07 Lot# 1060U Site RA" None.Allergy to amoxicillin and cefzil.MRI of left foot- revealed bursitis and bone marrow edema to left calcaneus and talus. CT scan of left foot- normal. X-rays (twice) of left leg/foot- normal. Blood work- normal. . During the same period patient was treated with Ortho Tri-cycle. Patient recovered.

HPV (GARDASIL) Side Effects Report #349873
HPV (GARDASIL) vaccine side effect was reported on 06/22/2009. Female patient, 22.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Blood test, "Seizure 3 hours post administration of HPV 1st seizure - no other risk factors. 7/9/09 Hospital ED records received DOS 6/15/09. Assessment: New onset seizure, possibly secondary to tramadol use. Relative reports that patient while on bus had an onset of shaking of upper extremities, right extremities in a 'frozen' kind of extension. Eyes rolled back, some saliva, lips turned blue. Patient woke up and was confused. Exam reveals only slight right lateral nystagmus. Medical Center and neurology referral and MRI suggested." NoneNone. 7/9/09 Hospital ED records received DOS 6/15/09. HeadachesWent to ER. had CT scan & blood tests. 7/9/09 Hospital ED records received DOS 6/15/09. LABS and DIAGNOSTICS: CBC - HGB 11.8 g/dL (L) HCT 34.8% Neutrophil 67% (H) Lymphocyte 15% (L). Other labs and diagnostics WNL. . During the same period patient was treated with 7/9/09 Hospital ED records received DOS 6/15/09. Ultram. Patient recovered.

HPV (GARDASIL) Side Effects Report #350359
HPV (GARDASIL) vaccine side effect was reported on 06/29/2009. Female patient, 21.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Blood test, "First event 4 days after vaccine (2nd) dose...vaginal lesions, nausea,vomitting, headache -E.R visit diagnosed with herpes, all subsequent tests negative - 6/7/09 headache, fever, lesions: mouth and vaginal, aspetic meningitis, hospitilized for 5 days- diagnosed with Behcets disease 7/16/09 Medical records received DOS 7/25/07 to 7/08/2009. Assessment: Meningitis, viral unspecified. Behcet's Syndrome. Patient presents with papular lesion on outer vaginal opening. Vulva - White papular lesions. Vulvovaginitis. Increasing painful multiple ulcers vaginal area, purulant discharge, pain with urination. Genital herpes. Wart right hand. Vulvovaginitis. Hospitalized for viral meningitis. Rash: torso and arms -hyperpigmented patches, legs - flesh colored nontender papules. Consultation note: Oral-genital ulcers with papular rash and meningeal symptoms. 7/16/09 Hospital discharge summary DOS 6/14/09 to 6/17/09. Assessment: Behcets Patient presents with 3 days of severe frontal headache. 2 oral ulcers on tongue and 4 genital ulcers. Intermittant raised rash on torso and extremities. Nausea and vomiting. Not taking adequate PO." none"7/16/09 Medical records received DOS 7/25/07 to 7/08/2009. Penicillin allergy, C. Trachomatis, Anxiety disorder.""MRI, CAT Scan, Lumbar puncture, blood tests. 7/16/09 Medical records received DOS 7/25/07 to 7/08/2009. LABS and DIAGNOSTICS: ESR 22 mm/hr (H) CBC - RBC 4.15 M/MM3 (L) MONO 9.2% (H) 7/16/09 Hospital discharge summary DOS 6/14/09 to 6/17/09" . During the same period patient was treated with "birth control,prozac. 7/16/09 Medical records received DOS 7/25/07 to 7/08/2009. Oral contraceptives Lo/Ovral, Gyne-Lotrimin, Prozac, Bentyl.". Patient was hospitalized 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: Blood test, "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 #351601
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: Blood test, "07-08-2009 Patient came home with chills and fever; started vomiting during night. Fever was up to 103.5. Also had lower back pain and headache. Vomiting and fever continued and went to Dr. on 7-10-2009 and was diagnosed with viral illness and started on antibiotic and compazine. Was admitted to Hospital later that day because of elevated WBC, and was diagnosed with Kidney infection, Sepsis and Disseminated Vascular Deterioration. Was in hospital for 5 days. 7/22/09 Hospital records received DOS 7/11/09 to 7/15/09. Final Diagnoses: Pyelonephritis, Disseminated intravascular coagulation, Hypokalemia, Thrombocytopenia, Acute anemia due to disseminated intravascular coagulation. Patient presented with fever and persistent vomiting. Generalized pain back and neck. Abdominal tenderness and right constovertebral angle tenderness. Heart rate 120. Pharyngeal erythema. Decreased urinary flow. Blood per rectum, vaginal bleeding, nosebleeds. 7/24/09 ICD-9 Codes: 590.80 286.6 287.5 276.8 285.9" None"None. 7/22/09 Hospital records received DOS 7/11/09 to 7/15/09. Mono, allergy to Cefaclor.""Elevated WBC and Low platelets. 7/22/09 Hospital records received DOS 7/11/09 to 7/15/09. LABS and DIAGNOSTICS: Urine - E. coli. Blood - E. coli. Urine Dip - 500 leukocyte esterase, positive nitrites, 250 blood. CBC - RBC 3.44 m/uL (L) HG" . During the same period patient was treated with None. Patient was hospitalized Patient recovered.

HPV (GARDASIL) Side Effects Report #352090
HPV (GARDASIL) vaccine side effect was reported on 07/15/2009. Female patient, 71.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Blood test, "Information has been received from a 72 year old female consumer with blood pressure high, cholesterol and Oesophageal Reflux acid reflux concerning herself who was vaccinated with a dose of GARDASIL instead of the ZOSTAVAX (Merck) by mistake on 06-Jun-2009. Concomitant therapy included Aspirin, Minerals (unspecified), and Vitamins (unspecified), Centrum silver, Fish oil, Calcium citrate and Citracal D, Prilosec, Felodipine, Lipitor and Micardis. The reporter mentioned that she was not experienced any side effects, but was worried and need to know if she needed to be concerned. Unspecified blood work as performed (results not provided). At the report time the outcome was unknown. Additional information has been requested." Blood pressure high; Cholesterol high / Oesophageal Reflux acid reflux"Diagnostic Laboratory - unspecified blood work, results not provided." . During the same period patient was treated with Aspirin; Lipitor; Citracal D; Felodipin; Centrum silver; Omega-3 marine triglycerides; Micardis. Patient recovered.

HPV (GARDASIL) Side Effects Report #352220
HPV (GARDASIL) vaccine side effect was reported on 07/15/2009. Female patient, 22.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Blood test, "Information has been received from a registered nurse concerning a 22 years old female with unknown medical history and unknown drug allergies who on 16-JUN-2009 was vaccinated with the first dose of GARDASIL at 4:00pm. Concomitant therapy included MUCINEX. ~Starting at 10:30pm the patient started having episodes of weakness, burning, tingling pain and a metallic taste from her tongue to her toes.~ ~She had these episodes 15-20 times before going to the hospital.~ At 12:23am on 17-JUN-2009 the patient went to the ER Room but was not admitted. She underwent unspecified blood work (results not reported). She was released at 3:45am that same day. When the patient got vaccinated her blood pressure was 125/72. At the hospital it was 156/94. The patient had recovered on 17-JUN-2009. Additional information has been requested." UnknownUnknown . During the same period patient was treated with MUCINEX. Patient recovered.

HPV (GARDASIL) Side Effects Report #352321
HPV (GARDASIL) vaccine side effect was reported on 07/15/2009. Female patient, 22.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Blood test, "Information has been received from a physician concerning a 22 year old female who ~four months ago~ in approximately February 2009, was vaccinated with the first dose of GARDASIL and two months after the first dose, ~two months ago~ in approximately, April 2008, the patient was vaccinated with the second dose of GARDASIL. The physicist stated that he gave the first dose of GARDASIL and twelve hours later the patient's boyfriend called the doctor and stated that the patient fainted and then could not walk. The doctor sent the patient to the emergency room. A full workup was done. The patient was fine. There was no problems. The patient was not on birth control pills and she was not pregnant. The patient is fine now. Additional information has been requested." Unknown"diagnostic laboratory, full work up including a blood work up: the patient was fine" . During the same period patient was treated with Unknown. Patient recovered.

HPV (GARDASIL) Side Effects Report #351795
HPV (GARDASIL) vaccine side effect was reported on 07/18/2009. Female patient, 14.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Blood test, "2nd dose of gardasil administered in check in room in left upper arm. Allowed to go, walked around the corner to check out and my daughter's eyes rolled back in her head and she began falling backwards. As she fell, her arms were drawn into her chest and her back was arched. She hit the floor full force on the back of her head and her hands remained tensed and pulled to her chest and her eyes began moving back and forth rapidly and then went back into her head again. Her pulse at this time was 62. She was in a total state of confusion once she regained consciousness and was very listless. A dr began asking her questions which she was unable to answer some of. No one checked her pupils with light. An ambulance was called from the hospital adjacent to the clinic and she was admitted to the ER. For the first 30-45 min in the ER she cried uncontrollably from the pain and her mood took an agressive turn. Her blood sugar was checked and an attempt to give her tylenol by mouth was made but she was combative and would not take it. She was taken to have a CT scan and returned. The CT came back normal and urine and blood were checked. We were discharged with a diagnosis of vasovagal syncope. My daughter had a seizure and not just a fainting spell. I witnessed the drawing up of the arms and the eye movements. I honestly thought she was dieing right there in from of me. She is a VERY healthy child involved in sports with no history of fainting or seizures and none in our family. As of today, she is still suffering from a severe headache and nausea so I would not be able to say she has recovered." NoneNone"CT scan, blood sugar level (84), blood and urine taken (not sure what was checked)" . Patient recovered.

HPV (GARDASIL) Side Effects Report #352473
HPV (GARDASIL) vaccine side effect was reported on 07/24/2009. Female patient, 19.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Blood test, "Information has been received from a consumer concerning her 19 or 20 year old niece with no known drug reactions/allergies and no pertinent medical history who over a year ago was vaccinated with the third dose of GARDASIL. There were no concomitant medications. The consumer reported that since receiving the third dose her niece had experienced ongoing occasional joint pain, muscle pain, tingling in her hands, and fainting spells ever since and was hospitalized. Labs diagnostic studies performed included checked heart and blood work (results not provided). At the time of reporting the patient had not recovered. The patient sought unspecified medical attention. No further information is available." UnknownUnknown . During the same period patient was treated with Unknown. Patient was hospitalized Patient recovered.

HPV (GARDASIL) Side Effects Report #353124
HPV (GARDASIL) vaccine side effect was reported on 08/04/2009. Female patient, 27.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Blood test, "Approximately 1 month after receiving the second dose of the Gardasil vaccine (manufactured by Merck - I am unable to load that in the information section below), I began experiencing numbness in my right leg. The numbness was persistent and progressive - it began in the right leg, but soon spread to the left leg, as well as my face and tongue. I also experienced poor balance, poor vision, confusion, and overall weakness. I was admitted to the hospital 3 weeks later, and kept for one week while receiving intravenous corticosteroids as treatment. 8/24/09 consultant records 1/09-received for numbness of right leg below knee right face and tongue numbness between Oct 07 and Feb 08 when symptoms improved and then in March 08 recurrent symptoms. Developed diplopia, dizziness, cognitive impairment, abdominal problems and fatigue. Impression: MS." none"A multitude of blood tests were done, along with MRIs, x-rays, and a lumbar puncture 8/24/09-records received-JC Virus DNA, QN RT-PCR <500." . Patient was hospitalized Patient recovered.

HPV (GARDASIL) Side Effects Report #354114
HPV (GARDASIL) vaccine side effect was reported on 08/13/2009. Female patient, 22.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Blood test, "Blood work was done as a routine physical one year after vaccine was distributed and the patients blood platelet count was at a low of 90 (normal range 140-400) Primary physician suggested that patient see a hemotologist, over the last year 2008-2009 patient has undergone routine bloodwork 01-09, 03-09, 05-09, and platelet count was still low, then Hemotologist had patient do a bone marrow biopsy to see if maybe her marrow wasnt producing enough platelets, biopsy showed that marrow was producing a healthy count of platelets, so after much blood work and evaluation, patient now has an auto-immune disease called ITP where her immune system is killing off her platelets leaving her with a low range of platelets, prior to the vaccination blood work shows normal range of platelet counts." mitro-valve regurgitation"Blood work done every 1-4 months, as well as a bone marrow biopsy" . 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: Blood test, "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 #354464
HPV (GARDASIL) vaccine side effect was reported on 08/17/2009. Female patient, 17.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Blood test, "Information has been received from a physician concerning a 17 year old female with childhood seizures from age 5-11 years old and had been seizure free since 11 years old and with no drug reactions/allergies. On 05-AUG-2009 the patient was vaccinated IM with the first 0.5ml dose of GARDASIL. The patient had been on DEPAKOTE (last dose was at age 13). On 05-AUG-2009 three hours after she received GARDASIL the patient had a grand mal seizure with loss of consciousness. The patient was seen in the emergency room at the hospital. There was no family history of seizure noted. The lab diagnostics studies performed: Genetic blood tests, ~CBC~, ~CMP~ urine analysis, ~EKG~ and all were negative. The patient was scheduled for a 48 hours Electroencephalography (EEG) next week. The physician requested to have WAES form faxed to him and he would provide all needed information. At the time of report the patient's status was recovering. Upon internal review, grand mal seizure was determined to be an other medical event. Attempts to obtain follow-up information have been unsuccessful. Additional information has been requested." Convulsion in childhood"electrocardiogram, negative; diagnostic laboratory, ~CMP~ urine analysis; hematology, genetic blood tests negative; complete blood cell, negative" . During the same period patient was treated with Unknown. Patient recovered.

HPV (GARDASIL) Side Effects Report #354631
HPV (GARDASIL) vaccine side effect was reported on 08/19/2009. Female patient, 14.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Blood test, "First injection of Garadsil was given to my daughter on July 21, 2009. A few weeks later her hair has begun to fall out severely. She has not had any change to her diet, no new medications, no new hair care products, in the past year. 9/4/09 Received vaccine & PCP medical records. Records reveal patient experienced general good health on 7/21/09. RTC on 8/18/09 w/hair loss." none"none 9/4/09 Medical records received w/PMH: pertussis vax reaction 1995. PE tubesx 2, T&A, bronchitis, viral exanthem, OM, strep throat, cat bite, sinusitis, vaginitis, conjunctivitis, viral syndrome.""No tests have been performed yet. Visit to the pediatrician. No diagnosis given yet. Dermatologist appt. scheduled. 9/4/09 Medical records received w/LABS: WBC 12.0 (H), neutros 79%(H), lymphs 16%(L). TSH 3.450(L), T4 0.92(N). Lipas" . 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: Blood test, "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: Blood test, 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 #354800
HPV (GARDASIL) vaccine side effect was reported on 08/20/2009. Female patient, 21.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Blood test, "FAINTING, DIZZYNESS HEADACHE , STARTED THESE FAINTING SPELLS AFTER THE 2ND SHOT THAT WAS IN 6/09 HAS FAINTED 6 TIMES. PUT ON BETA BLOCKER AND FLORINEF BY DOCTOR,BEEN TO TWO SPECIALIST FOR HEART, MAY WANT TO PUT IN PACE MAKER. WAS DIAGNOSED WITH NEUROCARDIOGENIC SYNCOPE. WE ARE VERY INTERESTED TO FIND ABOUT HOW TO BE DETOXED FROM THESE SHOTS 12/31/09 Medical records received for date 6/11/09. Pt had OV for vax. No other info provided." NONENONE"EEG, EKG, CAT SCAN, HEART HALTER MONITOR, TILT TABLE TEST BLOOD WORK" . During the same period patient was treated with BIRTH CONTROL - YAZ. Patient recovered.

HPV (GARDASIL) Side Effects Report #354906
HPV (GARDASIL) vaccine side effect was reported on 08/20/2009. Female patient, 16.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Blood test, "Information has been received from a registered nurse and a certified medical assistant concerning a 16 year old female with migraine headaches and allergy to cephalosporin who on 27-JUL-2009 was vaccinated with a 0.5 ml IM first dose of GARDASIL (lot no. 661953/1130X). No other vaccines were given that day. Concomitant therapy included ORTHO EVRA. On 28-JUL-2009 the patient stated she developed a rapid heart rate ~it feel like it was rushing out of my chest~, standing cause her to loose her breath and dizziness. The symptoms continued through the entire day and into the next. On 29-JUL-2009 the patient was seen at emergency room and was diagnosed with supraventricular tachycardia (SVT) with a heart rate of 200 (bmp). The patient was not hospitalized. The patient underwent cardioversion and was released with heart rate in the 90's (sinus rhythm). On an unspecified date, the patient recovered from supraventricular tachycardia. A blood work and a electrocardiogram (EKG) was performed (results not reported). The patient is being followed by a cardiologist and another physician who reported that holter monitor results were ~fine.~ The reporter stated that supraventricular tachycardia was not related to therapy with GARDASIL. Supraventricular tachycardia was considered to be life threatening an other important medical event. A lot check has been initiated. No further information is available. 8/28/09 ER records received DOS 7/29/09. Assessment: Arrhythmia - Supraventricular tachycardia. Patient complains of palpitations and heart racing. Chest pain and difficulty breathing. 10/13/09 ICD-9 Codes received: 427.89 Other specified cardiac dysrhythmia, 780.4 dizziness, 786.05 paroxysmal nocturnal dyspnea, 785.1 palpitations, 785.0 Tachycardia unspecified." Migraine; Drug hypersensitivity8/28/09 ER records received DOS 7/29/09. Caffeine."cardiac monitoring, results were fine; total heartbeat count, 07/29/09, 200, beats per minute; total heartbeat count, 07/29/09, 90, sinus rhythm. At discharge. 8/28/09 ER records received DOS 7/29/09. LABS and DIAGNOSTICS: Pulse 184. CBC" . During the same period patient was treated with ORTHO EVRA. 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: Blood test, "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: Blood test, "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 #355019
HPV (GARDASIL) vaccine side effect was reported on 08/19/2009. Female patient, 18.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Blood test, Right leg had no feeling/wd not support weight. Dizzy/Light Headed. Blacked out. 8/26/09 PCP note received. Pt in for PE on 6/29/09 HPV vax given./pc 9/21/09 Spoke with parent. Still reports some numbness as well as new symptom of twitching of the fingers. Has not seen a physician since the ER./pc NoneNone"Had EKG; Blood test; Inner Ear, sit, stand tests- Everything came back normal." . During the same period patient was treated with None. 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: Blood test, "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 #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: Blood test, "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 #355728
HPV (GARDASIL) vaccine side effect was reported on 08/27/2009. Female patient, 18.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Blood test, "1st vaccine: 11/28/08; Rash on hands appeared soon after, seen by Dr. on 12/7/09 for rash; 2nd vaccine: 2/7/09; 3rd vaccine: 5/1/09 followed by extreme tederness at site and muscle fatigue and pain all over body; numerous doctor visits, tests, and muscle bioposies led to diagnosis on 8/6/09 of dermatomyositis by Dr. During this period (11/28/08 - 5/1/09) rashes also appeared on elbows, knees, hips, and face. In looking back over the time period, there appears to be a connection between the vaccinations their impact on her immune system. Medical literature suggests a possible link between Gardasil and juvenile dermatomyositis, a disease that only affects 5 in 1 million people. 9/1/09 PCP medical records received DOS 2/3/09 to 8/19/09. Assessment: Nonspecific liver enzyme elevation. Nonspecific myalgias, joint complaints, possible rheumatological disorder. On 5/1/09 patient presented with complaints of a red, puritic rash. On the dorsum of and fingers of both hands, concentracted around MCP joints. Later complains of achiness and fatigue on arms and legs, sleeping more. Rash on elbows and knee. 1/7/2010 ED records received. Service date 6/29/09. Assessment: Lympahdenopathy, difficulty swallowing. Patient c/o that it is hard to swallow. Cervical lymphadenopathy. Body aches. Myalgia, sore throat, rash." none9/1/09 PCP medical records received DOS 2/3/09 to 8/19/09. Egg Allergy."Patient has had numerous blood tests, skin biopsies, muscle biopsies. Muscle biopsy conducted by University of Iowa confirmed diagnosis of dermatomyositis. 9/1/09 PCP medical records received DOS 2/3/09 to 8/19/09. LABS and DIAGNOSTICS: E" . During the same period patient was treated with None prior to 5/1/09. 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: Blood test, "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 #356334
HPV (GARDASIL) vaccine side effect was reported on 08/27/2009. Female patient, 13.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Blood test, Severe hair loss. Headaches. 10/14/09 PC note servce dates 12/18/09 to 8/6/09. Patient's hair is falling out. NoneNoneblood work 8-14-09 to check for cause of hair loss . During the same period patient was treated with None. Patient recovered.

HPV (GARDASIL) Side Effects Report #356394
HPV (GARDASIL) vaccine side effect was reported on 09/01/2009. Female patient, 17.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Blood test, Pt got GARDASIL # 3 given as injection; approximately 5 mins later stood up; was walking out of room and fainted. Pt also had blood drawn as well and hadn't eaten much that day. NoneNone . During the same period patient was treated with On birth control (TRI-PHASIL). Patient recovered.

HPV (GARDASIL) Side Effects Report #356417
HPV (GARDASIL) vaccine side effect was reported on 09/02/2009. Female patient, 25.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Blood test, "Information has been received from an approximately 25 year old female patient with ~cysts in the ovaries that were not a problem~, papilloma viral infection and an allergy to benzyl peroxide and a history of caesarean section (2002) who in 2008 was vaccinated with GARDASIL. The consumer already had HPV prior to vaccination with GARDASIL. Concomitant therapy included DEPO-PROVERA. The patient reported that she experienced dizziness after each dose of GARDASIL. All 3 doses were given over a 6 month period. The physician assistant recommended GARDASIL because ~it would be helpful for her current HPV infection~. The dizziness lasted for a couple of weeks after each vaccination. There was swelling at the site of injection after each dose and the site was pretty painful for 2 or 3 days. There was an occasional nausea within 1 week after each dose which seemed to coincide with the dizziness. The dizziness seemed to cause the nausea. The patient also had increased pain with cysts in the ovaries that had gotten worse since she received all 3 doses. ON approximately 28-JUL-2009 one of the cysts that was 2 inches in size ruptured and the patient was hospitalized. The patient still has day to day pain from the cysts. The patient did not have dizziness or nausea that stopped a few weeks after the 3rd dose of GARDASIL. At the time of the report the patient was not recovered from the other adverse events. The patient sought medical attention at office visit. On an unknown date a blood test was performed and it was normal, also a biopsy of cervix prior to vaccinations was performed (results not provided). Additional information has been requested. 9/14/09 PCP medical records received DOS 9/7/07 to 10/18/07. Patient complains of ovarian pain and cyst." Ovarian cyst; Papilloma viral infection; Hypersensitivity. 9/14/09 PCP medical records received DOS 9/7/07 to 10/18/07. ColposcoCaesarean section. 9/14/09 PCP medical records received DOS 9/7/07 to 10/18/07. DepoProvera. PAP mild dysplasia."diagnostic laboratory, Blood test Normal. 9/14/09 PCP medical records received DOS 9/7/07 to 10/18/07. LABS and DIAGNOSTICS: Urinalysis - Leukocytes trace, (+) nitrite, protein trace. TSH. CBC. CMP." . During the same period patient was treated with DEPO-PROVERA. Patient was hospitalized Patient recovered.

HPV (GARDASIL) Side Effects Report #356590
HPV (GARDASIL) vaccine side effect was reported on 09/06/2009. Female patient, 13.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Blood test, "My daughter was adminstered GARDASIL (I cannot find it in your list of vaccines below/ Ch.-B.: NE51780, NE51790, NF56940) on May 5, 2007, July 10, 2007, and January 14, 2008. A few months later (middle of 2008) she began to complain about joint pains that have now been diagnosed officially as rheumatoid arthritis. She has never been exposed to cigarette smoking, no alcohol or drug abuse or any other behavior that might have triggered the disease. Her maternal grandmother was diagnosed with it in her mid-40's, but she used to be a heavy smoker, and only has a light bought. Again, I cannot think of any other external trigger that might have been responsible for the illness other than the questionable Gardasil immunization, because it is closely related in time: shortly after the immunization the arthritis broke out." NoneHashimoto (Thyroid)"The RA diagnosis has been established (after examination and blood tests) on July 22, 2009 by Dr. at the Hospital" . During the same period patient was treated with None at the time. 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: Blood test, "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 #356915
HPV (GARDASIL) vaccine side effect was reported on 08/25/2009. Female patient, 13.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Blood test, "Severe headache and dizziness after Gardasil Shot! 9/29/09 Medical records received from dates of service 2/2/09 to 8/24/09 PCP, Allergist, ENT, Neurologist. Patient seen by PCP 2/2/09 DX:sinusitis. Presenting with HA. 3/9/09 and 3/18/09 visits no change and C/O HA. 3/24/09 Allergist consult, normal findings. 4/05/09 Neurologist consult DX: tension HA or mixed migraine HA cannot be ruled out suggest to see a specialist for TMJ for clicking in jaw. 4/20/09 and 4/30/09 PCP visit DX:allergic Rhinitis. 5/6/09 ENT consult DX: reccurent sinusitis." "None 9/29/09 Medical records received from dates of service 2/2/09 to 8/24/09 PMH: HA, sinusitis, allergic rhinitis.""Bloodtests, CT, MRI, EEG, ENT-Doctor twice, x-rays. All these tests were done between April and May 2009. 9/29/09 Medical records received from dates of service 2/2/09 to 8/24/09 Diagnostics/ Labs: CT face-mucosal thickening within the inf" . Patient recovered.

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: Blood test, "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 #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: Blood test, 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 #358135
HPV (GARDASIL) vaccine side effect was reported on 09/23/2009. Female patient, 15.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Blood test, "2ND HPV VACCINE GIVEN ON 4/2/09. ON 7/9/09 CLIENT HAD HIVES FROM HEAD TO TOE INCLUDING ARMS, LEGS, AND TRUNK. HIVES ALSO INSIDE HER MOUTH. SHE WENT TO E.R. AND RECEIVED A CORTISONE INJECTION. ETIOLOGY OF THE HIVES UNKNOWN BY PHYSICIAN. ON 7/10/09 SHE SEEN PCP WHO OBTAINED LAB WORK AND MEDROL DOSE PACKET PRESCRIBED BUT CLIENT WAS UNABLE TO SWALLOW PILLS. 7/11/09 WENT TO E.R. R/T HIVES TO LIPS AND MOUTH AND PT. WAS HAVING DIFFICULTY BREATHING FEELING TIGHTNESS TO CHEST. SHE WAS GIVEN EPINEPHRINE AT THE E.R.-THEN ALL SYMPTOMS RESOLVED WITHIN 48 HOURS. THEN ON 8/20/09 CLIENT RECEIVED HER 3RD HPV INJECTION. ON 9/5/09 CLIENT EXPERIENCED LOWER RT. ABDOMINAL PAIN AND BLOATING. ALSO HAD 3 MENSES IN 9/09 AND REPORTS IS USUALLY REGULAR WITH MENSES OCCURRING EVERY 28-30 DAYS. THE 2ND WEEK OF SEPT./09 SHE WENT TO CARE AND SEEN PHYSICIAN WHO ORDERED AN ABDOMINAL CT SCAN SHOWING FECAL IMPACTION. THE CLIENT TOOK MAGCITRATE WITHOUT RESULTS. CLIENT STATES SHE NORMALLY HAS REGULAR BOWEL MOVEMENTS. HER ABDOMINAL PAIN CONTINUED EVEN AFTER HAVING A BOWEL MOVEMENTS. TWO DAYS LATER SHE WENT TO URGENT CARE AND HAD LAB OBTAINED TESTING HER URINE AND BLOOD WHICH SHE REPORTS CAME BACK NORMAL. SHE REPORTS THE SEVERE ABDOMINAL PAIN CONTINUED. ON 9/22/09 CLIENT COMPLAINED OF LT. ARM PAIN AT THE HPV INJECTION SITE AND HAVING 1 SMALL HIVE AT THE INJECTION SITE WHICH WAS NOTICED BY HER MOTHER-LATER IN THE DAY THERE WAS A RAISED INDURATION GREATER THAN 1CM PALPATED AT THE INJECTION SITE. CLIENT ALSO REPORTS ON 9/22/09 HAVING A RASH TO BOTH UPPER THIGHS, TIGHTNESS IN HER CHEST, AND DIFFICULTY BREATHING. CLIENT PLANS TO FOLLOW-UP WITH HER PCP AND WILL REQUEST AN ABDOMINAL ULTRA SOUND. 9/28/09 Urgent care records received DOS 9/16/09. Assessment: Abdominal pain, constipation. Patient presents with abdominal pain of one week duration. 10/19/09 Primary care records received for dates of service 8/28/97 to 7/9/09 Assessment: Seen for hives on 7/9/09. Right lower abdominal pain and sore throat on 9/25/09." NONO. 10/19/09 Primary care records received for dates of service 8/28/97 to 7/9/09. PMH: None.URINE AND BLOOD TESTING DONE WAS NORMAL. ABDOMINAL CT SCAN SHOWED FECAL IMPACTION. 9/28/09 Urgent care records received DOS 9/16/09. LABS and DIAGNOSTICS: CT Scan - feces noted. CBC - Eosin 7.5% (H) Eosin 0.7 T/CMM (H). CHEM - ALP 66 U/L . During the same period patient was treated with NO. Patient recovered.

HPV (GARDASIL) Side Effects Report #358667
HPV (GARDASIL) vaccine side effect was reported on 09/28/2009. Female patient, 16.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Blood test, "Information has been received from a physician concerning his 16 year old daughter with no pertinent medical history and no known drug allergies who on 30-JUN-2009 was vaccinated IM with a first 0.5ml dose of GARDASIL (lot# not reported). There was no concomitant medication. On 14-SEP-2009 the patient experienced severe, crampy, intermittent left upper abdominal quadrant pain. On 19-SEP-2009 the patient was admitted to hospital. Blood work, computed axial tomography (CT) scan, and abdominal magnetic resonance imaging (MRI) were normal. The test results on the patient came back as positive for Epstein Barr virus. The patient received pain management with hydrocodone and intravenous morphine. The patient was discharged on 20-SEP-2009. At the time of the report, the patient had not recovered. Severe, crampy, intermittent left upper abdominal quadrant pain and positive for epstein barr virus were considered to be disabling. Additional information has been requested." None"Diagnostic laboratory, 09/19/09, Blood work was normal; Computed axial, 09/19/09, normal; Magnetic resonance, 09/19/09, abdominal: normal; Serum Epstein-Barr, 09/19?/09, positive" . During the same period patient was treated with None. Patient was hospitalized Patient recovered.

HPV (GARDASIL) Side Effects Report #358742
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: Blood test, Myalgia - severe. Chest pain tightness in lower arms. NoneAllergic rhinitis.ESR; CBC; CRP; CMP; ANA. . Patient recovered.

HPV (GARDASIL) Side Effects Report #358916
HPV (GARDASIL) vaccine side effect was reported on 09/30/2009. Female patient, child 11.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Blood test, "Diagnosed with Type 1 diabetes two months later. Frequent urination started 6 wks after vaccination and diagnosed with diabetes 8 wks after vaccination. 1/7/2010 PCP records for 2 wellness visits, 4/2008 and 5/2009, on second visit it states patient on an Insulin pump x 2 months, stable HgbA1C, Dx IDDM" none - vaccination was given at regular 11 yr old well child care check up"allergic to sulfa medications PMH: Diabetes , scoliosis Allergies: Sulfa"blood tests . During the same period patient was treated with nothing. 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: Blood test, "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 #359039
HPV (GARDASIL) vaccine side effect was reported on 09/30/2009. Female patient, 18.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Blood test, "Information has been received from the parents concerning their daughter, an 18 year old female patient with no pertinent medical history and drug reactions/allergies who intramuscularly received the first 0.5ml dose of GARDASIL (lot#660557/0072X) on 10-JUL-2008 and the second dose (lot#661531/1311X) on 22-DEC-2008. Concomitant therapy included SYNTHROID and CYTOMEL. It was reported that the first vaccination was given concomitantly with meningitis vaccine (manufacturer unknown). In February 2009, the patient has had 3 strep infections. On 10-APR-2009, the patient developed chronic mononucleosis. It was also reported that in approximately April 2009, the patient started ~swelling up, developed hashimoto's thyroiditis, she has also gained 35-40 pounds~. The patient has not been able to return to school this year. The patient's father reported that the patient was a ~college athlete~. The patient had sought unspecified medical attention. Unspecified blood work has been performed, but the result was not reported. At the time of the report, the patient was recovering. Swelling up, chronic mononucleosis, hashimoto's thyroiditis and 3 strep infections were considered to be disabling. A lot check has been initiated. Additional information has been requested." NoneUnknown . During the same period patient was treated with SYNTHROID; CYTOMEL. Patient recovered.

HPV (GARDASIL) Side Effects Report #359263
HPV (GARDASIL) vaccine side effect was reported on 10/03/2009. Female patient, 15.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Blood test, "Syncope - Running a 5K, child is a half marathoner and 5K state champion. Pulse went to 172. Ash gray in face and memory loss of event. This had never happen before, occurred again on 10/3/2009. Emergency room, doctor ran EKG and ECO showed nothing. 10/28/2009 records from Cardiologist and PCP for dates 9/22/2009 and 10/13/2009. Patient presented with sx of syncope, incoherent speech, paleness, and ~passing out~ while running a marathon on 9/19/2009. Cardiac workup was negative. Patient saw new PCP 10/13/2009, asymptomatic at this time. Further dx tests were ordered." None"None PMH: Anorexia Nervosa, Amenorrhea Allergies: NKDA""Blood work, sugar level check, EKG and ECO all negative. Labs: CBC, CRP, CMP, complement studies, ANA profile, ESR, TSH, Ferritin WNL Dx tests: Echo, Holter monitoring, EKG WNl" . Patient recovered.

HPV (GARDASIL) Side Effects Report #359622
HPV (GARDASIL) vaccine side effect was reported on 10/05/2009. Female patient, 15.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Blood test, "Information has been received from a Registered Nurse concerning her 16 year old daughter who on 29-JUN-2007 was vaccinated with a first dose of GARDASIL (lot # not reported). On 29-AUG-2007 she received second dose of GARDASIL (lot # not reported). On 02-JAN-2008 she received third dose of GARDASIL (lot # not reported). On 29-APR-2009 the patient experienced acute pancreatitis and was hospitalized. On an unspecified date the patient recovered from acute pancreatitis. Laboratory test revealed: Amylase level: 3200 and lipase level 2000. Follow up information has been received on 30-SEP-2009 via telephone call from Medical Assistant (the patient's mother) (previously reported as Registered Nurse). The Medical Assistant stated that her daughter received first dose of GARDASIL (lot # 657736/0389U) on 29-JUN-2007. On 29-AUG-2007 she received second dose of GARDASIL (lot # 657736/0389U). On 02 - JAN-2008 (previously reported as 02-JAN-2007) she received third dose of GARDASIL (lot # 659055/1522U). The patient did not receive any concomitant vaccinations when GARDASIL vaccinations were administered. The Medical Assistant stated that the patient experienced abdominal pain on 29-MAR-2009. The patient was taken to the hospital but was not admitted. Later that day, the patient was taken to other hospital. The patient was admitted with complaint of abdominal pain on 29-MAR-2009 (previously reported as 29-APR-2009) and was diagnosed with acute pancreatitis. The patient was discharged on 01-APR-2009. The patient had recovered. The name of the Primary Care physician was provided. The patient complained of abdominal pain, (date not reported). In May 2009 the patient had her gall bladder removed (hospitalization dates unknown to reporter). On an unspecified date the patient recovered. On 31-AUG-2009, the patient complained of abdominal pain and was taken to the hospital. The patient's blood tests (test unspecified) were normal. The patient was not admitted to the hospital. The Medical Assistant stated that the patient had experie" PMH: none; Allergies: NKDA."diagnostic laboratory 08/31/09, Blood tests were normal; serum amylase test, 03?/??/09, 3200; serum lipase test, 03?/??/09, 2000 01/07/10 and 01/08/10 MR and DC summary received for DOS 03/29/09-04/01/09. DX studies: no electrolyte abnor" . During the same period patient was treated with Unknown. Patient was hospitalized Patient recovered.

HPV (GARDASIL) Side Effects Report #359747
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: Blood test, "Ashley complained of fast heart rate, dizziness, numbness and tingling in hands and feet. 10/12/09 Medical records received from dates of service 10/2/09 to 10/8/09 10/2/09 OV for c/o ball in throat feeling, acne, hair loss and to begin gardasil vaccination series. DX: questionable reflux, acne, hair loss. 10/8/09 OV c/o HA, dizziness, moody, heart racing, jerking arms, tingle in fingers occurring after getting gardasil vaccination. DX: HA, dizziness, tachycardia." Feel has a Ball in throat. History hair loss but regrowing hair.General anxiety disorder 10/2/09 MH: Anxiety disorder"Saw her therapist and talked with her psychiatrist. 10/2/09 Labs: TSH WNL, CBC WNL. 10/8/09 Labs: Influenza A(-) B(-)." . During the same period patient was treated with Buspar. 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: Blood test, "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 #360945
HPV (GARDASIL) vaccine side effect was reported on 10/14/2009. Female patient, 14.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Blood test, "Information has been received from a registered nurse concerning a 14 year old female who on 08-OCT-2009 was vaccinated with her second 0.5mL dose of GARDASIL (route and lot number not reported). Concomitant therapy included FLUMIST. IT was reported that half an hour later, on 08-OCT-2009, the patient experienced passed out, hit her head and had a seizure. The patient was taken to the emergency room and was released. The physician felt it was important to note that the patient had not eaten prior to vaccination. The patient recovered from hit her head, passed out and seizure on the same day. Follow up information was received from a registered nurse concerning the 14 year old female patient with no pertinent medical history reported and no known drug allergies who on 08-OCT-2009 was vaccinated with her second dose of GARDASIL (lot number 663451/0216Y) and concomitantly with a dose of FLUMIST (lot number 500711P). The registered nurse reported that the patient left the office and was in a restaurant when she ~passed out and stiffened~ on 08-OCT-2009. The patient was taken to the ER where a CT of the head, EKG, chest X-ray and blood work were performed (all normal). No treatment was needed. It was noted that the patient received the first dose of GARDASIL (route not reported, lot number 664780/0904Y, valid for ROTATEQ) on 16-JUL-2009. Upon internal review, seizure was determined to be an other important medical event. Additional information has been requested." None"electrocardiogram, 10/08/09, Normal; chest X-ray, 10/08/09, Normal; head computed axial, 10/08/09, Normal; diagnostic laboratory, 10/08/09, Blood work: Normal" . Patient recovered.

HPV (GARDASIL) Side Effects Report #361035
HPV (GARDASIL) vaccine side effect was reported on 10/15/2009. Female patient, 21.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Blood test, "2 swollen lymphnodes on left neck and 1 on right neck. After blood work December and again in May (with a chest X-ray), results came back inconclusive and was concluded to be a result of vaccination. LAD still present today. Lymph nodes seemingly more reactive to illness than ever before. 10/26/2009 records from multiple MD visits. Patient with c/o's swollen cervical lymph nodes, noted since 9/2008. PE: noted multiple rt and lt sided subcentimeter nodules that were mobile and non-tender. No tx noted, patient to return if any enlargement or change in nodules is noted." NoNo PMH: none Allergies: NKDA"Blood work Chest X-ray negative for LAD in chest. Labs: Cbc, rbc and mchc low. Thyroxine 13.3 high, Bmp wnl, Esr normal at 11, cat scratch, monotest neg Dx tests: Cxr wnl Received follow up doses in January and August 2008 (approximate" . During the same period patient was treated with Nuva Ring. Patient recovered.

HPV (GARDASIL) Side Effects Report #362859
HPV (GARDASIL) vaccine side effect was reported on 10/22/2009. NA patient, 20.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Blood test, "Disoriented, numbness in body, lack of concentration, dizzy, high anxiety." NoneNoneBlood work-up & MRI . 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: Blood test, "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: Blood test, "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 #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: Blood test, "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 #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: Blood test, "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: Blood test, "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 #366031
HPV (GARDASIL) vaccine side effect was reported on 10/30/2009. Female patient, child 12.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Blood test, "Generalized tonic clonic seizure. Final DX; Generalized seizure, resolved, lymnphocytosis, Recent URI Tonic clonic sz <1 min. Short post ictal. All diags neg. Increased lymphocytes, viral illness. Phenergan for recent URI, cough. Neuro PE neg. D/C to home stable. Refer to neuro. Abnormal EEG. Complex partial seizure. MRI ordered. ICD9 Codes: 780.39 12/17/09 ED Medical records received for DOS 10/27/09" None"PMH: intermittent nocturnal incontinence, learning disability Allergies: UNK""CBC; ct scan; chem panel - negative. Labs & Diags: Lymphocytes 10% (H), EEG - spikes, epileptic in character 12/17/09 LABS: Urine toxicology: negative, MRI brain: venous angioma of left cerebelar hemisphere; brain CT: unremarkable." . Patient recovered.

HPV (GARDASIL) Side Effects Report #366259
HPV (GARDASIL) vaccine side effect was reported on 11/09/2009. Female patient, 13.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Blood test, "Patient had vaccines on 12/17/2008, 2/23/2009, and 6/23/2009 and began experiencing a swollen finger in 5/2009. This proceeded over the next few months to her finger joints and down her tendon to her wrist. She is diagnosed with psoriatic arthritis because of her inflammation of joint and tendon (tenosynovitis) in her left hand. They want to treat her with methotrexate to attack this auto-immune disorder. 11/23/09 Medical records received for date 5/28/09. DX: left middle finger tenosynovitis. Pt presented w/ c/o left mid. finger swelling, unable to recall any injury. OV 8/4/09 Cont. c/o swelling left mid. finger no extends to palm of hand. Ref. to ortho." NoNo"MRI shows tenosynovitis, hospital has run many blood tests and x-rays. Visits to 2 orthopedic surgeons, 1 rheumatoid arthritis doctor, and 1 eye surgeon." . During the same period patient was treated with Received tetanus shot and 1st dose of Gardasil on 12/17/2008. Received second dose of Gardasil on 2/23/2009 and third dose on 6/23/2009. Took Advil from May to June to try and decrease swelling of tendon and joint in finger.. Patient recovered.

HPV (GARDASIL) Side Effects Report #366298
HPV (GARDASIL) vaccine side effect was reported on 11/09/2009. Female patient, 17.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Blood test, "Information has been received from a mother, for the Pregnancy Registry for GARDASIL, concerning her daughter, a 17 year old female with a history of antibiotic therapy and no known drug reactions/allergies, who on 22-APR-2008 was vaccinated (route unknown) with a 0.5 mL first dose of GARDASIL (Lot # unknown). Concomitant therapy included (BACTRIM, also reported as ~Bectrum~). The mother reported the pregnancy for her daughter. The patient was administered with the first dose on 22-APR-2008 and as of 3-May-2008 she is 5 weeks pregnant (LMP ~March 2008~). The lot # is not provided. No AE involved. A blood test was performed. Unspecified medical attention was sought. No product quality complaint was involved. Follow up information was received from the nurse who indicated that on approximately 23-DEC-2008 the patient had an induction of labor after she came into the office with some contractions and elevated blood pressure (bp). During the induction the patient ~quit dilating~ and at 38 +2/7 weeks had a Cesarean section. On 23-DEC-2008 the patient delivered a normal baby, with Apgars values of 8 and 9 at 1 and 5 minutes respectively and only required a bulb syringe suctioning, ~but no further resuscitation~, the nurse also reported ~everything looked good~ with the baby. The patient also had a postpartum hemorrhage, and was transfused two units of packed red blood cells. Post-operatively the diagnosis was pre-eclampsia and chorioamnionitis. She also received antibiotics (unspecified) for the chorioamnionitis. The nurse also reported that the baby had a sepsis workup due to the mother's chorioamnionitis, but he was asymptomatic and all of his laboratory tests were normal also. The baby was discharged home with his mother on 26-DEC-2008. At the time of the report, the outcome of the patient was unknown. Upon internal review pre-eclampsia, chorioamnionitis and patient quit dilating and having a C section were considered as other important medical event. Additional information is not expected." Antibiotic therapy"diagnostic laboratory, pregnant" . During the same period patient was treated with BACTRIM. Patient was hospitalized 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: Blood test, "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: Blood test, "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: Blood test, "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 #369112
HPV (GARDASIL) vaccine side effect was reported on 11/20/2009. Female patient, 14.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Blood test, "Onset seizures suddenly 5/2/09 while skating, treated 5 hrs at ER then transferred to Ped ICU x 4 days episodes. Had 2 more seizure episodes 5/18/09, 6/2/09. ER visits, DILANTIN used and d/c 6/6/09. 11/23/2009 HR and DC summary for 5/2-5/6/2009. Dx conversion disorder Patient with seizure-like activity with rt sided tremors and slurred speech. Tx: IV Ativan and Dilantin, ABX and Acyclovir. Psych consult impression was conversion disorder" noneAsthma since 4 y.o. - mild; Medication PRN; No other PMH: Asthma as a child now resolved Allergies: NKDA"All tests negative (MRI; CT; Blood; Spinal Tap; EEG; Video EEG) Labs: CBC, CMP, urine tox screen, EB virus, Enterovirus, CSF cell ct and culture, HSV PCR panel, all negative/normal Dx studies: CT Head wnl, EEG wnl, VEEG wnl, MRI brain no" . During the same period patient was treated with "ADVAIR 250 AM, PM; MAXAIR 1 puff". Patient was hospitalized 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: Blood test, "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 #370786
HPV (GARDASIL) vaccine side effect was reported on 11/30/2009. Female patient, 29.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Blood test, "Information has been received from a consumer concerning her 29 year old daughter with ~allergies of many unspecified medications~ and no pertinent medical history, who was vaccinated with ~all three doses~ of GARDASIL, respectively on 29-MAR-2007, 29-MAY-2007 and 02-OCT-2007. There was no concomitant medication. On 09-NOV-2009 the patient experienced ~seizures~. Labs and diagnostic tests included ~routine blood work~, result not reported. The patient visited physician for medical attention and had not recovered. Upon internal review, seizure was considered to be an other important medical event. Additional information has been requested. 12/07/09 ED received for DOS 12/01/09 DX: Gastroenteritis. Pt c/o vomiting and diarrhea and unable ~to keep anything down~. On examination: anxious, chills, depressed and abdominal pain. tx: Zofirax. Pt discharged home." Hypersensitivity"12/07/09 ED received for DOS 12/01/09 PMH: Neurocardiogenic syncope, appendectomy and cholecystectomy; Allergies: Cefactor caps, IV dyes, latex, PCN, Unasyn."12/07/09 ED received for DOS 12/01/09 DX studies: Pain rating 4/10. CBC: negative. . During the same period patient was treated with None. Patient recovered.

HPV (GARDASIL) Side Effects Report #371336
HPV (GARDASIL) vaccine side effect was reported on 12/03/2009. Female patient, child 11.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Blood test, "VISION PROBLEMS, SWOLLEN OPTIC NERVE, PAPILLEDEMA. WENT TO SPECIALISTS AND STARTED TESTING. HAD EYE EXAMS, ULTRASOUNDS OF EYES, SPINAL TAP, MRI, BLOOD WORK AND VISUAL FIELD. POSSIBLE OTHER TEST 12/04/09 Opthalmology records received for DOS 04/11/08-09/19/08. Pt. presents with difficulty with hand work x 1-2 weeks DX: papilledema 12/04/09 Medical records received for DOS 04/11/08, 04/16/08, 04/18/08, 04/29/08 12/04/09 Neuro-opthalmology records received for DOS 06/18/08 DX: visual fields enlarged blind spot, right eye; bilateral optic nerve drusen 12/04/09 PCP records received for DOS 03/09/07-07/10/09." NONO 12/04/09 PMH: right knee plica; sinusitis; acne; NKDA."SPINAL TAP, BLOOD WORK, MRI, VISUAL FIELD AND ULTRASOUNDS AND BAYBE OTHERS 12/04/09 Labs/Diagnostics: MRI brain: normal; AB Bartonella: negative; Free T4: 0.73 (L); ANA: not detected; WBC 13.6 (H); CSF culture: rare WBCs; Ultrasound optic" . Patient recovered.

HPV (GARDASIL) Side Effects Report #371392
HPV (GARDASIL) vaccine side effect was reported on 12/03/2009. Female patient, 15.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Blood test, "60 second generalized tonic-clonic seizure followed by a second one 6 hours later; MRI negative; EEG markedly abnormal with frequent burst suppression activity; LP normal. No active infectious or neurological etiology found. Treating with antiepileptic and seeing slow recovery of mental status. 12/10 12/23 12/24 1/5/09: Hospital records received for dates of service 11/13/09 to 12/19/09: Dx: Encephalopathy, seizures, spinal lesion. Hospitalized after onset of tonic clonic seizures with bilateral upper and lower extremity shaking lasting 30 to 60 seconds with no respiratory compromise and urinary incontinence, unusual fatigue, fever, headache, sleeping more than normal. Hx. of enuresis worsened with admission, taking Dilantin and Trileptal. EEG abnormal but without epileptiform discharges. Also poor memory, poor appetite, ten pound weight loss over past month, nystagmus on lateral gaze both right and left, ataxic gait and slow, slurred speech. Intensive care unit admission after seizure with prolonged apnea. PICC Line placed. Treated with IVIG with marked improvement, though she did have a reaction to the IVIG with fevers, abdominal pain and a few days of low blood pressure. Discharged on antiepileptics." None"Possible bipolar. 12/10 12/23 12/24 1/5/09: Hospital records received for dates of service 11/13/09 to 12/19/09: PMH: Wheezing, ADHD, Bladder infection, Allergy to amoxicillin, RAD.""MRI - normal blood/CSF cultures - negative 12/10 12/23 12/24 1/5/09: Hospital records received for dates of service 11/13/09 to 12/19/09: Labs and diagnostics: Enterovirus PCR-Negative, CSF-no growth, MRI Brain-WNL. CT Spine-abnormal" . Patient was hospitalized 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: Blood test, "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 #372812
HPV (GARDASIL) vaccine side effect was reported on 12/10/2009. Female patient, 26.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Blood test, "Information has been received from a nurse practitioner and a 26 year old female consumer for the Pregnancy Registry for GARDASIL concerning herself who on 19-MAY-2008 was vaccinated intramuscularly in the deltoid with her first dose of GARDASIL (lot# not reported) and became pregnant. There was no concomitant medication. The patient's LMP was 19-MAY-2008 and EDD was 23-FEB-2009. Subsequently the patient experienced no adverse symptoms. The patient sought medical attention with an office visit on an unspecified date. The patient had blood work and a urine pregnancy test to confirm the pregnancy. The patient's outcome was not reported. Follow-up information was received from the consumer who stated that she had a baby boy who is now nine months old; healthy and normal with no problems. She also said her pregnancy was ~very good~, and she was one week overdue when she went into labor. Additionally she reported an ~emergency~ cesarean section during labor because the baby ~wasn't coming down~ and had the umbilical cord wrapped around his arm and after a while~ he couldn't take it any more~. The reporter stated the baby was fine after he was born and she recovered very well from the surgery. Upon internal review, umbilical cord abnormality was considered an other important medical event. Additional information is not expected." Pregnancy NOS (LMP = 5/19/2008)"diagnostic laboratory; urine beta-human, positive" . During the same period patient was treated with None. Patient recovered.

HPV (GARDASIL) Side Effects Report #374319
HPV (GARDASIL) vaccine side effect was reported on 12/21/2009. Female patient, child 11.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Blood test, "Mom called 12/21/09-states child received 3rd HPV vaccine on 12/17/09 8 AM-that night child was taken to ER with H/A, lethargic, numbness and tingling in (L) arm and leg and chest pain (L) side, vision blurred. States had CT scan that was neg. and bloodwork. Then sent to another hospital-was there about 12 hrs then sent home. Pt. had been having H/A's for the last 2-3 months." nonenoneCT scan; bloodwork . During the same period patient was treated with none. Patient was hospitalized Patient recovered.

HPV (GARDASIL) Side Effects Report #374960
HPV (GARDASIL) vaccine side effect was reported on 12/23/2009. Female patient, 27.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Blood test, "Information has been received from a registered nurse, for the Pregnancy Registry for GARDASIL, concerning a 27 year old female with PENICILLIN allergy and no other medical history who was intramuscularly vaccinated with the first and second 0.5 ml doses of GARDASIL on 14-July-2008 and 15-Sep-2008 (1st lot #660557/0072X) 2nd lot #659184/0843X), respectively. Concomitant therapy included diphtheria toxoid/tetanus toxoid which was vaccinated with the first dose of GARDASIL. Subsequently the patient became pregnant after receiving GARDASIL. The due date of pregnant gestation reported as 13-May-2009. No adverse effect reported. Laboratory diagnostic studies included prenatal blood tests. The patient sought unspecified medical attention. Follow up information was received from the registered nurse who reported that the patient had a history of irregular periods and she had reported that she was not pregnant at the time of her vaccination with GARDASIL in September 2008. The reporter administered the vaccine to the patient and estimated that the patient was approximately 5 weeks pregnant at the time of vaccination. On 30-Apr-2009 this patient delivered her baby by c-section following spontaneous rupture of membranes. Amniotic fluids were clear. Patient was GBS negative. Gestational age was 38 weeks +. It was also reported that the patient experienced cholelithiasis during pregnancy on 23-Mar-2009 and underwent a cholecystectomy on 27-May-2009. Upon internal review, c-section following spontaneous rupture of membranes was considered to be an other important medical event. The baby's experience has been captured WAES # 0901USA00343B1. Additional information has been requested." Pregnancy NOS (LMP - 08/06/2008) PENICILLIN allergyIrregular periodsUnknown . Patient recovered.


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