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White blood cell count increased from HPV (GARDASIL) 2008

Vaccine Manufacturer:MERCK & CO. INC.
Vaccine Code:HPV4
Vaccine Type:HUMAN PAPILLOVAVIRUS QUADRIVALENT
Vaccine Name:HPV (GARDASIL)
Year Reported:2008
Symptom Reported:White blood cell count increased

HPV (GARDASIL) Side Effects Report #303135
HPV (GARDASIL) vaccine side effect was reported on 01/07/2008. Female patient, 16.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: White blood cell count increased, "Information has been received from a consumer, concerning her 16 year old daughter with no pertinent medical history, who on 21-NOV-2007 was vaccinated in the left arm, with the first dose of Gardasil (lot # not reported). There was no concomitant medication. On 23-NOV-2007 the patient experienced spotting that lasted for 11 days. She also developed an ~enlarged lymph, like an almond sized node~ in her groin and left arm pit, vomiting and nausea, ~has always been crying,~ and is not acting like herself (dates not specified). On 27-NOV-2007, the patient had labwork performed, inclusive of a screen for hepatitis B, with results indicative only of an elevated white blood count. On 03-DEC-2007, the had an ultrasound of her spleen and kidneys, with no abnormal results found. At the time of this report the outcome of ~spotting~ was recovered, and the outcome of all remaining events was not recovered. Additional information has been requested." None"renal ultrasound, 12/03/07, normal; abdominal ultrasound, 12/03/07, normal; WBC count, 11/27/07, elevated; serum hepatitis B, 11/27/07, negative" . During the same period patient was treated with None. Patient recovered.

HPV (GARDASIL) Side Effects Report #306103
HPV (GARDASIL) vaccine side effect was reported on 02/14/2008. Female patient, 16.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: White blood cell count increased, "Information has been received from a nurse concerning a 16 year old female with no pertinent medical history or drug reactions/allergies, who on unspecified dates was vaccinated with the first, second and third doses of Gardasil. There was no concomitant medication. On 01-JAN-2008 the patient experienced prolonged headache ~after receiving the third dose of Gardasil.~ ~As of 22-JAN-2008, the headache had not subsided~. It was reported that the patient ~did not receive the Gardasil at the office.~ No product quality complaint was involved. Medical attention was sought at the physician. Additional information has been requested. Follow-up received 04/16/2008. The patient complained of severe prolonged headache for 3 weeks following the third dose of Gardisil vaccine on 02-JAN-2008. On 22-JAN-2008 the patient was seen in the office. The patient's body temperature was 97.9 degrees C and the blood pressure measurement was 112/62. The headache was in the eye area and at the top of the head. The patient was not getting headaches in the AM but in themiddle of the day and last til the evening. The headache sometimes resolved with sleep. Acetaminophen hcl (TYLENOL) helps. The patient limits activity. Throbbing and squeezing. The patient has had n o tress, no nausea or vomiting, no visual changes. Hard to concentrate no clumsiness. No fever/URI/cough. Her menses is regular. Eyes hurt but not watery. There is no prior history of headaches.On 30-JAN-2008 the patient stated that her headaches have improved. No product quality complaint was involved. Additional information is not expected." None"head computed axial, 01/29/08, brain with and without contrast, normal; blood pressure, 021/22/08, 112/62; ophthalmological exam, 01/22/08;complete blood cell, 01/23/08, normal; WBC, 01/23/08, 4.2, high; body temp, 02/22/08, 97.9 C;" . During the same period patient was treated with None. Patient recovered.

HPV (GARDASIL) Side Effects Report #306242
HPV (GARDASIL) vaccine side effect was reported on 02/29/2008. Female patient, 15.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: White blood cell count increased, "Information has been received from a consumer from Merck Pregnancy Registry for Gardasil concerning her 15 year old daughter with a history of urinary tract infection and kidney infection who in December 2007, was vaccinated with a first dose 0.5 mL of Gardasil (lot # unknown). Concomitant therapy included prenatal vitamins (unspecified), KEFLEX and iron (unspecified). On 31-JAN-2008 the patient developed coughing, severe high fevers, urinary tract infection and kidney infection. On 31-JAN-2008, she was hospitalized for five days. It was reported that she was pregnant for five months. Laboratory tests were performed but not specified. She was recovering. Additional information has been requested. 03/05/2008 MR received for DOS 1/31/2008 to 2/6/2008 with DX: Intrauterine Pregnancy at 18wks 5 days. R Acute Pyelonephritis. Shortened cervix with mild funneling, r/o cervical insufficiency/incompetance. Teen pregnancy with no prenatal care. Possible URI. Electrolyte disturbances (hyponatremia and hypokalemia). Incidental spina bifida occulta C7. Non-specific anemia, r/o sickle cell anemia. Pt presented to ER with c/o R flank pain and fever/chills x 3 days. Temp 101.6'F. Pt found to be pregnant on exam. Consult for bacteremia. Improved on IV Rocephin. Cervical cerclage performed on 2/6/08." Urinary tract infection; kidney infection"laboratory test - Unspecified. Labs and Diagnostics: UA (+) for large nitrite, large leukocyte esterase, WBCs TNTC. UC (+) for E.coli. Blood cx (+) for E. coli. Na+ 129. K+ 2.6. Cl- 95. Ca++ 8.3. CBC with WBCs 30.2 on admit, down to 7.0" . During the same period patient was treated with KEFLEX; iron (unspecified); vitamins (unspecified). Patient was hospitalized Patient recovered.

HPV (GARDASIL) Side Effects Report #306696
HPV (GARDASIL) vaccine side effect was reported on 02/07/2008. Female patient, 15.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: White blood cell count increased, "Gardasil (#1: 08/17/07) (#2 10-20-07) Dizziness (1) 09/17/07 Coldness (2) 01/17/08 Slurred speech with Headache. 04/07/2008 MR received from PCP beginning with WCC 5/2/2007 and including vax record and 2 ER records with DX: Vasovagal Syncope (9/19/2007) and Vasovagal episode, r/o seizure (1/16/2008). On 9//19/2007 pt presented to ER after near syncopal episode while running. Pt felt dizzy and almost passed out. Transported by EMS to ER. PE WNL. Seen again 1/16/08 after a fall/shaking episode. Pt reported feeling cold and being unable to speak. Suttering upon arrival to ED. PE WNL. D/C home to f/u as outpt. Seen by PCP 2/7/08 with c/o dizziness and pallor on 2/5/08. Under work-up" NoneNone"Neurology; Cardiology ENT referred EKG, MRI head, EEG. Labs and Diagnostics: 9/19/07: CBC WNL. EKG WNL. 1/16/08: CBC with WBCs 13.4. EKG WNL. Drug screen (-). Chemistry with CO2 31 and Ca 10.7 otherwise WNL. UA with Large amt blood, 11-20" . Patient recovered.

HPV (GARDASIL) Side Effects Report #306721
HPV (GARDASIL) vaccine side effect was reported on 03/07/2008. Female patient, 16.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: White blood cell count increased, "Information has been received from a physician via a company representative concerning a 17 year old who on an unspecified date was vaccinated with Gardasil IM. On approx 07-FEB-2008, ~about 3 weeks ago~ the patient developed neurological symptoms and was hospitalized for one week. The neurologist at the hospital diagnosed her with Miller Fisher variance of Guillain-Barre syndrome. At the time of reporting the patient ~improved but she's undergoing therapy~ and has not recovered. No further information was provided. The reporter felt that Miller Fisher variance of Guillain-Barre syndrome was disabling and required hospitalization. Additional information has been requested. 4/8/08-records received for DOS 2/6-2/12/08- DC DX: Guillain-Barre variant. Developed cough and diarrhea week prior to admission. Also had vomiting and fevers. On morning of admission developed tingling in hands and feet and dysarthric speech, blurry vision and difficulty with walking. Treated with IVIG with improvement of ataxia and dysarthria. CDC's CISA staff has reviewed this case and concluded that this case is not GBS." None 4/8/08-records received-PMH: Depression."4/8/08-records received-LP normal. MRI brain normal. CT head negative. WBC 16.31, absolute neurtrophils 13.6. M. IgG 2.06. Urine cutlure no growth." . During the same period patient was treated with Unknown. Patient was hospitalized Patient recovered.

HPV (GARDASIL) Side Effects Report #308368
HPV (GARDASIL) vaccine side effect was reported on 03/20/2008. Female patient, 15.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: White blood cell count increased, "Pt had N/V, fever, nasal congestion, sore throat, decreased sleep, facial rash, HA, myalgia. No relieve w/ OTC Benadryl. Exam at ED found neck pain w/ flexion consistent with meningismus and RUA tenderness, (+) Murphy sign. Admitted to hospital, IV fluids and IV antibiotics. Discharged home in improving condition. 03/28/2008 MR received with VAERS report for DOS 3/2-4/2008 with D/C DX: Acute sinusitis/viral syndrome (respiratory syncytial virus) and myalgias possibly due to immunizations that she received last week. Gastritis. Pt presented to ER with fever, sore throat, vomiting and facial rash. Pt with c/o stiff neck and h/a. PE (+) for facial petechiae, neck pain c/w meningismus and RUQ tenderness. Txd with abx and IVF and d/c improved 3/4/08." chronic diarrhea/IBS"asthma; migraine headaches; Irritable Bowel Syndrome. PMH: asthma, pneumonia, migraine h/a, IBS, alcohol use. NKDA.""WBC 29.1; RSV (+), LFT's - nl, CSF nl, CSF CX (-); Monospot (-); Strep CX (-); Flu (-); HIV (-); abdominal u/s - nl; head CT - nl except pansinusitis; UA nl; UCX (-); Preg (-); EBV IgM (-); EBV IgG (+). Labs and Diagnostics: CBC with WBCs" . During the same period patient was treated with Imitrex; OCP. Patient was hospitalized Patient recovered.

HPV (GARDASIL) Side Effects Report #309113
HPV (GARDASIL) vaccine side effect was reported on 01/04/2008. Female patient, 14.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: White blood cell count increased, "Syncope following injection. Rash began 11/21/07. ER visit diagnosed as erythema multiforme on 11/22/07. Symptoms worsened and was admitted 11/23/07 (night). Follow up with family doctor. Lasted approx. 2 weeks. 04/09/2008 MR received for ER visit 11/22/2007 with DX: Erythema multiforme minor. Pt presented with 2 day hx of rash which began on the hands and spread to the body. Pt also reports painful swelling of the hands. PE (+) for diffuse, asymmetric , maculopapular rash. Target lesions noted on palms, soles and extremities. Tx with benadryl and prednisone. 4/16/08 Additional records recd for admit 11/23-24/08 with D/C DX Erythema Multiforme. Dehydration 2' to vomiting, resolved. Pt presented with worsening rash,persistant vomiting, and significant swelling and pain in extremities. Pt had swelling of the lips. Temp 101. Presumed allergy to Minocin. Started on Z-pak for URI sx. D/C 11/24/08 and returned again 11/24/08 with worsening sx. Now developing mouth sores. PE (+) for lesions c/w Erytema Multiforme. PE (+) for shotty anterior cervical adenopathy and trace DTRs. Admitted again for IVF and meds. Additional DX: of probable drug eruption 2' Minocin." NoneNone"Labs and Diagnsotics: CBC with WBCs 23,000. down to 19,000. CXR WNL. Electrolytes and LFTs WNL. BS increased 2' IVF." . During the same period patient was treated with None at time of vaccine. On tetracycline x2 weeks at time of rash onset.. Patient was hospitalized Patient recovered.

HPV (GARDASIL) Side Effects Report #309168
HPV (GARDASIL) vaccine side effect was reported on 04/08/2008. Female patient, 21.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: White blood cell count increased, "Information has been received from a a registered pharmacist concerning a 21 year old female who with no pertinent medical history who ~7-8 days ago~ on approximately 21-MAR-2008 was vaccinated with a dose of GARDASIL (lot number, route and site of administration not specified). There was no concomitant medications. On an unspecified date the patient presented with bacterial meningitis and the only medication she was given was GARDASIL before this occurred. The patient was hospitalized on an unspecified date for an unspecified amount of time. At the time of reporting the patient was recovering. The reporter felt that bacterial meningitis was life threatening. Additional information has been requested. 4/24/08-records received for DOS 3/25-3/31/08-DC DX: meningitis, resolved. Presented with frontal headache. Progressive headache and at ER lethargic and obtunded. ICU- One episode ventricular tachycardia. Temperature 100.4." None 4/24/08-records received-PMH: several strep pneumonia manifested as upper respiratory tract infections throughout childhood."None 4/24/08-records received-Lumbar puncture analysis showed strep pneumonia bacteria in cerebrospinal fluid, protein 140, wbc 4831, segs, bands, lymph and monocytes of CSF elevated. . Blood culture strep pneumo bacteremia. EEG showing mo" . During the same period patient was treated with None. Patient was hospitalized Patient recovered.

HPV (GARDASIL) Side Effects Report #312529
HPV (GARDASIL) vaccine side effect was reported on 05/16/2008. Female patient, child 11.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: White blood cell count increased, "Information has been received from a physician concerning a 11 year old female patient with hypothyroidism who on 01-MAY-2008 was vaccinated with a first dose of Gardasil. Concomitant therapy included SYNTHROID. On 03-MAY-2008 the patient experienced encephalopathy after receiving the first injection, was seen at the emergency room (ER). Subsequently she was hospitalized. Laboratory diagnostic test spinal tap was done. No further information was provided. The patient had not recovered. Additional information has been requested. 06/16/2008 MR received from CDC for DOS 5/6-27/2008 with D/C DX: Meningoencephalitis. Hypothyroidism. Hypocalcemia. Pt presented to local ER with c/o pain in the arms and legs, headache and then episodes of shaking of the arms and legs, stool incontinence and unresponsiveness and progressive changes in mental status. In local ER had witnessed episode of eye rolling and shaking of the arms and legs. Transfered to current facility for further w/u. CSF showed WBC pleocytosis. PE (+) for brisk DTRs on the L and difficult to elicit on the R. 10/6/2008 Additional records received from initial ER 5/3/08. Pt presented with disorientation and not feeling well since 5/2/08. Had Gardasil 5/1/08. In ER had several episodes of tremors, clenched teeth, rigid, downward going toes and clenched hands drawn to the chest. Transfered to above facility to r/o meningitis." HypothyroidismPMH: Hypocalcemia. Hypothyroidism"spinal tap 05/03/08 - Partially abnormal. Labs and Diagnostics: CSF cell count 322 with 232 RBCs. CSF Glucose 79. CSF protien 113.7. Repeat 5/13/08 with CSF cell count down to 13, glucose 62, protein 22.4. CSF cx (-). Brain MRI c/w meni" . During the same period patient was treated with SYNTHROID. Patient was hospitalized Patient recovered.

HPV (GARDASIL) Side Effects Report #312897
HPV (GARDASIL) vaccine side effect was reported on 05/14/2008. Female patient, 17.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: White blood cell count increased, "Information has been received from a nurse concerning a 17 year old female with codeine intolerance who on 31-JAN-2008 was vaccinated intramuscularly with a 0.5 mL first dose of GARDASIL (lot # 659657/1487U). On 01-APR-2008 the patient was vaccinated intramuscularly with a 0.5 mL second dose of GARDASIL (lot # 659180/1758U). Concomitant therapy included hormonal contraceptives (unspecified). On 04-APR-2008, ~three days later~, the patient developed a rash on her legs. It was reported that she went to the emergency room. On 07-APR-2008 the patient was followed up at her doctor's office and was diagnosed with vasculitis. On 09-APR-2008 the patient ~had a flare up again~. The nurse reported that she had ~many tests done~. At the time of this report the vasculitis persisted. The patient is being treated with prednisone. Laboratory tests performed on an unspecified date showed an ~elevated sed rate~ and an ~elevated white count~. Additional information has been requested. 6/3/08 Reviewed PCP medical records for 4/7-5/1/2008. FINAL DX: vasculitis Records reveal on 4/7 visit, patient experienced itchy rash over bilateral LEs, aching in bilateral LEs & muscle spasms. Had been seen in ER on 4/4, 2 days s/p 2nd HPV vax, & diagnosed w/vasculitis, unclear etiology. Had undergone tanning session on day of ER visit. Intolerant of steroids. Tx w/antihistamine. Had no reaction s/p 1st HPV vax. Exam revealed bilateral LE multiple erythematous round macules & plaques generalized over lower pretibial area. Returned to office 4/9 w/worsening symptoms of rash & calf pain. Exam at that time revealed tenderness of bilateral calves w/trace edema, diffuse nodular urticarial erythematous lesions, coalescent purpura mostly over distal tibial area w/sparse involvement over thighs. Attempted tx w/steroids & additional labs. Testing for celiac disease (+) on 5/1/08. 6/3/08 Reviewed ER medical records of 4/4/2008. FINAL DX: vasculitis Records reveal patient experienced rash which started at ankles & progressed" Drug intolerance"PMH: mild allergic rhinitis, GERD, mono 2006, recurrent strep throat & tonsillectomy 2007.""erythrocyte, elevated; WBC count, elevated LABS: WBC 26.4 (H), plts 515,000 (H). WBC 11.8 (H), segs 79% (H), lymphs 15% (L). Sed rate 51 (H). ANA (+). CRP 1.9 (H). ASO 333 (H). Throat c/s w/rare B-hemolytic strep goup A. Rheumatoid" . During the same period patient was treated with hormonal contraceptives. Patient recovered.

HPV (GARDASIL) Side Effects Report #314559
HPV (GARDASIL) vaccine side effect was reported on 06/02/2008. Female patient, 16.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: White blood cell count increased, "05/31/08- SOB and chest pain 06/01/08- Chest pain, pericardial effusion, Pericarditis 6/3/08-records received for DOS 5/31-6/2/08-DC DX: Pericarditis. Presented with chest pain for about 10 days and 2 days after vaccination for human papilloma virus." NONE"Asthma 6/3/08-records received- PMH: asthma. PMH: bronchial asthma. Penicillin allergy, peanut allergy, allergy to pertussis vaccine.""6/3/08-records received-D-dimer mildly elevated, CK increased 198, WBC 15.4, eosinophils % low 0.1, total protein elevated 8.8, anion gap elevated 17, globulin elevated 4.0. CT scan showed evidence of mild pericardial effusion.6/6/08-lab re" . During the same period patient was treated with "Ventolin, Prednisone, Zithromax, Ibuprofen". Patient was hospitalized Patient recovered.

HPV (GARDASIL) Side Effects Report #315135
HPV (GARDASIL) vaccine side effect was reported on 06/04/2008. Female patient, 17.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: White blood cell count increased, "Information has been received from a pharmacist concerning a female (age unknown) who, on an unspecified date, was vaccinated with a first dose of GARDASIL. Subsequently, the patient was diagnosed with Hodgkin's lymphoma. The patient was seen at the office. At the time of the report, the patient was in remission. No product quality complaint was involved. Upon internal review Hodgkin's lymphoma was considered to be an other important medical event. This is an amended report. The serious criteria of other important medical event was changed to yes for Hodgkin's lymphoma. Additional information has been requested. 06/09/2008 MR received from oncologist which include PCP records as well as outside consultant records. Pt seen by pediatriction 2/27/07 with lymphadenopathy at the base of the neck. Initially thought to be r/t recent dx of mono in November 2006. RTO 4/10/07 with same, as well as chills and fatigue. Refered to oncologist and seen 5/2/2007. Dxd with Hodgkin's Disease following excisional lymph node bx. Staged at level IIA. Port placed for chemo-6 cycles of ABVD, which was successful in achieving remission. No evidence of recurrence at f/u visits." Unknown. PMH: Innocent murmur. Infectious mono 11/2006. Chicken pox Allergy to Amoxicillin-rash/hivesUnknown. Labs and Diagnostics: Lymph node bx (+) for nodular sclerosing Hodgkin's Disease. CT scan (+) for supraclavicular mass and multiple enlarged lymph nodes in the mediastinum. Bone marrow bx- no evidence of hodgkin's. ESR 29. CMP . During the same period patient was treated with Unknown. Patient recovered.

HPV (GARDASIL) Side Effects Report #316288
HPV (GARDASIL) vaccine side effect was reported on 06/13/2008. Female patient, 18.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: White blood cell count increased, "Information has been received from a consumer concerning her 18 year old daughter with pseudotumor cerebri and scoliosis and no drug reactions or allergies, who on 15-APR-2008 was vaccinated with the first dose of GARDASIL. Concomitant therapy included YAZ and acetazolamide (MSD). The patient's mother stated that her daughter has the condition known as pseudotumor cerebri. As a result of this condition, she sometimes has a build up of intercranial and spinal pressure which causes severe headaches and problems with her eyes, such as pain and sensitivity to light. Prior to receiving the vaccine on 15-APR-2008, her last episode of this increase and build up of intercranial and spinal pressure took place in March 2007. On 11-MAY-2008 the patient had another one of these episodes which caused her to have severe headaches, and problems with her eyes such as pain and sensitivity to light. She was hospitalized for one day so that her physician could do a spinal tap. Subsequently, the patient recovered. No product quality complaint was involved. Additional information has been requested.7/21/08-records received for 5/16/08-DC DX: Pseudotumor cerebri. Presented to ED with 5 day history of intermittent headache and 1 day of nausea and vomiting. Headache worse at night and associated with phot and phonophobia. Nauseated and vomiting times two." Pseudotumor cerebri; Scoliosis7/21/08-records received-PMH:scoliosis. Seasonal allergies. Diagnosed with PTC March 2007 well controlled until day of admission."diagnostic laboratory, 05/11?/08, no results reported; spinal tap, 05/11?/08, no results reported 7/21/08-records received-LP normal. WBC increased 12.8, PT 14.8 and INR 1.2." . During the same period patient was treated with DIAMOX; YAZ. Patient was hospitalized Patient recovered.

HPV (GARDASIL) Side Effects Report #318680
HPV (GARDASIL) vaccine side effect was reported on 07/10/2008. Female patient, 15.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: White blood cell count increased, "Symptoms of and diagnosed with ulcerative colitis in November 2007 requiring 2 hospitalizations for exacerbation since 11/2007 7/14/08-records received-office visit 7/31/07-C/O tired. 11/28/81-DX ulcerative colitis. Loose stools and abdominal spasms. Tired weak. 12/24/07-GI consults-history of ulcerative colitis in remission. Presented with abdominal pain, diarrhea, anemia and hypoalbuminemia. Weight loss, joint pains. 2/18/08-Continues in remission. Flu symptoms 10 days ago. Intermittent shoulder, ankle and wrist pain. 5/30/08-Sick visit, off steroids. Three days prior increasing stooling and minor bleeding and severe cramps. 7/21/08-records received for DOS 5/31-6/4/08-DC DX: ulcerative colitis flare. Presented with 2 weeks of abdominal cramping and 3 days of diarrhea tht had become bloody. Nausea." NoneReactive Airway Disease 7/21/08-records received-PMH:ulcerative colitis diagnosed 11/2007."Bloodwork, colonoscopy 7/21/08-records received-Sed rate increased 37, amylase increased 102 and lipase 470, WBC 15.1 and CRP 3.55. Abdominal series 11/22/07-no acute abdominal findings. Abdominal series:11/5/07-large amount of retained st" . During the same period patient was treated with Albuterol Inhaler for PRN use. Patient was hospitalized Patient recovered.

HPV (GARDASIL) Side Effects Report #319654
HPV (GARDASIL) vaccine side effect was reported on 07/16/2008. Female patient, 16.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: White blood cell count increased, "5 day hospitalization for severe, first-ever pancreatitis. Pt was on Ortho Evra, and had recently - 5/23/08 - completed GARDASIL series. 8/4/08-records received for DOS 7/2-7/7/08- DC DX: Acute pancreatitis possibly secondary to hypertriglyceridemia. Mild iron deficiency anema. Obesity. Protein malnutrition, fevers, elevated inflammatory markers resolving. Dyslipdemia. C/O one day history of severe abdominal pain." Older sister had pancreatitis at roughly the same age. 8/4/08-records received-PMH: long history of having low blood. Sister recently diagnosed with pancreatitis and DM."WBC 21.1; ESR 55 8/4/08-records received-total cholesterol 223, triglycerides 260, HDL 62 and LDL 109. CT peripancreatic stranding consistent with pancreatitis. WBC 20,000, hemoglobin 12.5, chemistry normal, LFTs elevated amylase 112, lipa" . During the same period patient was treated with ZOMIG; OrthoEvra. Patient was hospitalized Patient recovered.

HPV (GARDASIL) Side Effects Report #320219
HPV (GARDASIL) vaccine side effect was reported on 07/07/2008. Female patient, 16.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: White blood cell count increased, "Pt received 1st GARDASIL 11-7-07, 2nd GARDASIL 1-29-08, DX with Pancreatitis 5-7-08. x\x of pancreatitis 4-24-08. Recovered 5-21-08 DX with cholecystitis on 5-23-08. 5/7/08 also dx with mono. 08/26/2008 MR received for DOS 5/7-8/2008 with D/C DX: Acute Pancreatitis. Nausea with vomiting. Abdominal pain. Mono. Mesenteric lymphadenopathy. Pt presented to ER with 2 wk hx of nausea with vomiting, fatigue and sore throat. Initially dx with H pylori, now with worsening LUQ pain, N&V. Increased lipase and amylase on labs. Tx with IV hydration and abx. Improved and d/c next day." NoneNKA. PMH: none. NKDA"Labs and Diagnostics: Lipase >2000, Amylase 251-both reduced by d/c. Anion gap 14. Glucose 111. GFR 79. CBC with WBCs 17. CT of abdomen and pelvis (+) for mesentaric lymphadenitis. US of GB (-). EBV IgG>4000. EBV nuclear antigen >1000. T" . During the same period patient was treated with YAZ; Albuterol inhaler. Patient was hospitalized Patient recovered.

HPV (GARDASIL) Side Effects Report #320480
HPV (GARDASIL) vaccine side effect was reported on 07/25/2008. Female patient, child 12.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: White blood cell count increased, "3 MONTHS AFTER PATIENT RECEIVED VACCINE, SHE CAME TO CLINIC C/O FEVER, JOINT PAINS, SORE THROAT AND HEAD ACHE. STARTED ON ANTIBIOTICS. PT. CLINICAL STATUS GOT WORSE, FEVER PERSISTED, NUCAL RIGIDITY AND PHOTOPHOBIA. REFERED TO WAKE MED HOSP TO R/O MENINGITIS. 7/29/08-records received for ED visit 11/2/07-presented with fevers since 10/28/07-initially seen by PCP on 10/30/07 for sore throat and antibiotics but did not start treatment until 11/1/07-on 10/30/07-developed diffuse rash and seen at another ED where antibiotic was changed, patient did not start the treatment-returned to PCP on 11/1/07- with C/O worsening sore throat and diffuse upper abdominal pain, temp 104 and now at ED 102.9. Mild frontal headache and 1 episode of emesis. PE:tonsils mildy erythematous, diffuse maculopapular rash to arms and legs and fine papular rash to bilateral inner thighs and trunk. 8/5/08-records received for DOS 11/2-11/12/07-DC DX: Fever, myalgias, weakness, rash, proteinuria. Presented with one week history of fevers, stiff neck for 3 days and rash for 3 days. Sore throat for 5 days. Abdominal pain and diarrhea, bilateral wrist pain, full body myalgias and vomiting on 10/31 and 11/1/07. Leg pain, dizziness when standing and intermittent servere headaches for past 5 days. Transferred to another facility. 08/18/08-records received for DOS 11/23-11/26/07-DC DX: Stil's Disease/Systemic onset JRA.presented with C/O headache, altered mental status. New onset of neck pain associated with headace. Head bobbing tremor noted. Symptoms could be related to Prednisone." NONENONE"RMSF,PARVO 19 AND EBV TITERS NEGATIVE, PROTEINURIA AND HEMATURIA. ANA,Ds DNA,ANCA, ANTI DNA ANTIB AND RA ALL NEGATIVE. 7/29/08-records received-Potassium low 3.3, calcium low 8.4, WBC 11.0. urine occasional casts, mono spot test negative," . Patient was hospitalized Patient recovered.

HPV (GARDASIL) Side Effects Report #320751
HPV (GARDASIL) vaccine side effect was reported on 07/28/2008. Female patient, 17.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: White blood cell count increased, "Ok at beginning but then became sore. Increased symptoms 7/17 - swollen oval reddish circle, painful, fever. Taken to ER. CT then MRI. Fluid collection. Transferred to hospital. IV mbx then evacuation of fluid collection/abscess. Diagnosis - pyomyositis. 9/12/2008 MR received for DOS 7/18-24/2008 with DX: Pyomyositis. Pt presented to local hospital with increased swelling and tenderness of the L deltoid, fever and emesis. Transfered for eval and tx. PE (+) for 8x4 cm markedly indurated, swollen, erythematous area on L deltoid as well as redness to the face/chest. Decreased ROM of shoulder. US guided soft tissue fluid collection and aspiration (+) for purulent material. Tx with vancomycin." NoneNone. PMH: none"7/18 WBC 13.7 80% nat, 9% lymph - 7/21 CRP 7.2 - 7/22 abscess clx negative - 7/24 CRP 1.51 - 7/26 CRP ESR 24 blood clx negative. Labs and Diagnostics: CBC with WBCs 13.9. CT scan shows SubQ infiltration, no abscess. MRI (+) for inflammat" . During the same period patient was treated with None. Patient was hospitalized Patient recovered.

HPV (GARDASIL) Side Effects Report #320970
HPV (GARDASIL) vaccine side effect was reported on 07/24/2008. Female patient, child 11.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: White blood cell count increased, "Bad leg cramps and swelling in both legs. 8/11/08-records received for DOS 7/2-7/3/08-DC DX: Resolved leg pain. Petechial rash stopped to spread. Pharyngitis, tonsillitis resolving. Dehydration resolved. Presented with severe leg cramping, cold to lower extremities and bluish lower extremities. Developed rash day before admission. Sore throat, erythematous and swollen." 8/11/08-records received-WBC 14.1. . Patient was hospitalized Patient recovered.

HPV (GARDASIL) Side Effects Report #320988
HPV (GARDASIL) vaccine side effect was reported on 07/31/2008. Female patient, 17.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: White blood cell count increased, "5/20/08 - fever 103 and vomiting, 5/22/08 weak strep response and antibiotic given and got better, 5/25 101 fever and ER visit, high wbc count dx acute viral syndrome. After this extreme fatigue, anxiety, syncope (x2)in June and July, lightheadedness, weight loss (10 #), decreased appetite and floater in vision. 8/18/08-records received for DOS 5/25/08-presented to ED with C/O cough, sore throat, fever, chills, muscle aches and ~flu~ started 5 days agao. Diagnosed with Strep 4 days ago. Today developed fever. Nasal discharge. Moderate frontal headache. Impression:Acute viral syndrome." noneacne and seasonal asthma 8/18/08-records received-PMH: Asthma."5/22 weak positive strep test, 5/25 increased wbc count, negative mono test, negative chest xray, 7/25 workup for syncope - all labs normal, eeg normal. Completing EKG at a future date. 8/18/08-records received-CBC normal, WBC 12.8, chemi" . During the same period patient was treated with none. Patient recovered.

HPV (GARDASIL) Side Effects Report #321876
HPV (GARDASIL) vaccine side effect was reported on 08/11/2008. Female patient, 26.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: White blood cell count increased, "Information has been received from a nurse practitioner concerning her daughter, a 26 year old female with depression, asthma exercise induced and allergy to nuts who on 31-JUL-2008 was vaccinated with a third dose of GARDASIL (route and administration site not reported). Concomitant therapy included EFFEXOR. On 01-AUG-2008, within 12 hours of the vaccination, the patient experienced facial swelling and puffy cheeks. The patient then had tenderness of her neck and enlarged lymph nodes. She was treated with BENADRYL, ZYRTEC and ice packs. It was mentioned that the patient had no adverse reaction after the first 2 doses of GARDASIL. The patient's facial swelling and tenderness of neck and enlarged lymph nodes persisted. She sought medical attention in the office. Follow-up information was received. The patient became progressively worse on 01-AUG-2008 and 02-AUG-2008 with continued facial swelling and enlargement of both lymph nodes and salivary glands, and difficulty swallowing. The patient underwent CT scan, ENT evaluation and was admitted to the hospital. IV steroids and pain medicine were given. An antibiotic was also given to which she had an allergic reaction. An infectious disease consult was called. At the report time, the swelling has just started to regress slightly, but the parotid glands were tense and obstructed. Additional information has been requested. 08/28/2008 MR received for DOS 8/2-5/2008 with D/C DX: Sialadenitis, likely 2' to allergic reaction. Depression. Pt presented with facial swelling and pain which began the pm of HPV4 shot. Pt developed lip, eyelid and neck swelling initially, then shooting pain with neck movement or touch. Pt then developed difficulty swallowing and eventually difficulty breathing. On PE in ER voice is hoarse, swelling of eyelids, face, lips and neck. Tender to touch. Tonsils enlarged, touching uvula. Decreased neck ROM 2' to pain. Started on abx and steroids with allergic rxn to Clindamycin. Continued steroid tx with clinical improvement. To f/u w" Depression; Asthma exercise induced; Allergy to nuts"Anaphylaxis. PMH: Allergies to PCN, Compazine, Keflex, Clindamycin, nuts, red dye. Asthma. Depression. Pneumonia, Syncope, occ diarrhea""throat culture, 08/01/08, negative. Labs and Diagnostics: CT with patchy enhancement over the parotid and submandibular glans with edema in anterior SubQ, mucosal and deep tissues. CBC with WBC up to 16.5 with 91.0% neutro, 3.0% lymphs." . During the same period patient was treated with EFFEXOR. Patient was hospitalized Patient recovered.

HPV (GARDASIL) Side Effects Report #324908
HPV (GARDASIL) vaccine side effect was reported on 08/14/2008. Female patient, 16.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: White blood cell count increased, "Information has been received from a nurse concerning her 17 year old daughter who in 2007 received the first and on an unspecified date a second dose of GARDASIL. On 14-AUG-2007 was vaccinated with the third dose of GARDASIL (lot # 655618/0186U) 0.5 ml, IM. On 07-JUL-2008, the patient experienced pain, weakness and numbness in her right thumb and arm. Medical attention was sought, she had blood tests, was seen by a neurologist and will have an Magnetic Resonance Imaging (MRI) the week of 21-JUL-2008. The primary care doctor thought this may be associated with GARDASIL until he saw on the chart that the third dose was given in the opposite arm. At the time of reporting, the patient's pain and weakness and numbness persisted. No additional information at this time. Additional information has been requested. 9/16/2008 MR received from PCP. Seen 7/9/2008 with c/o acute onset of numbness which began in the R thumb and spread up to the level of mid triceps. PE (+) for decreased strength of the fingers, wrist and elbow. Sensory deficit to R mid tricep. Tearful and anxious re: symptoms. Ascending sensory deficit on R hand to upper arm with motor weakness. Reflexes intact. Referred to neuro. Neuro consult 7/11/08-improving numbness of unknown etiology. Numbness improving, now only to elbow. Pinprick and touch sensation diminished on R arm. F/U visit 3 weeks later with continued improvement. Still some numbness and decreased sensation of the hand. Will f/u with EMG and/or MRI PRN." Unknown. PMH: knee injury"magnetic resonance 07/21?/08. Labs and Diagnostics: CBC with WBC 11.6, Hgb 14.3, Hct 41.7, RBC 4.89Platelets 477. ESR 19." . During the same period patient was treated with Unknown. Patient recovered.

HPV (GARDASIL) Side Effects Report #322715
HPV (GARDASIL) vaccine side effect was reported on 08/19/2008. Female patient, 16.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: White blood cell count increased, "Received GARDASIL #1 6/25/08; Developed body aches and fever, joint pain 4 days after receiving vaccine. Seen by a rheumatologist - Diagnosed with systemic onset juvenile inflammatory arthritis requiring Kineret injections. 8/22/08-records received for DOS 7/16/08-presented to rheumatology clinic with C/O fever and arthritis which began 17 days ago with pain in right hip then pain all over. Fevers are down during day but up at night. Shaking chills and then defervesces with drenching sweats. Rash began on 2nd or 3rd day with red blotchy areas on extremities. Appetite poor and lost 6 pound in past week. Pain seems to be in joint with joint swelling. Dizziness. Office visit 8/11/08-Joint pain improved except shoulders are not strong. Tapering prednisone. Assessment:Systemic onset juvenile inflammatory arthritis on kineret. Possible adverse reaction to Gardasil." NoneNone"Blood work, followed by rheumatologist 8/27/08-records received-WBC 20,000, sedimentation rate elevated at 105 and C-reactive protein over 250. Ferritin elevated. ANA and ANCA negative. Complements normal. Serology for strep, EB virus and" . During the same period patient was treated with None. Patient recovered.

HPV (GARDASIL) Side Effects Report #322833
HPV (GARDASIL) vaccine side effect was reported on 08/20/2008. Female patient, 16.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: White blood cell count increased, "Information has been received from a consumer on a news station reporting that her teenage daughter (age not reported) was vaccinated with GARDASIL in December 2007. Subsequently in February 2008, 2 months after receiving GARDASIL the patient developed an ~autoimmune disease~. The patient developed a rash on her face and arms, leaving scars. She had swelling all over, pain in her joints and poor circulation in her fingertips. Her doctor says ~she now suffers from an autoimmune disease and says it is possible the GARDASIL triggered her illness~. The mother stated that her daughter had no prior illness or hospitalization. At the time of reporting the patient had not recovered. Upon internal review autoimmune disease was an other medical event. The reporter felt that the autoimmune disease was disabling. Additional information is not expected. 11/21/08 Reviewed PCP medical records o 12/12/07-10/01/2008. FINAL DX: SLE, mixed connective tissue disorder, anemia of chronic disease Records reveal patient in good general health 12/2007, sexually active but urine protein 300+ (H). Started on Bactrim. RTC 1/3/08 w/fatigue. RTC 2/08 w/symetric nodular rash on arms & face x 1 wk w/mild itching & aches/pains x 6 mo. Dermatology, Rheumatology, Nephro & GYN consult done & dx w/SLE (ANA+, rash & proteinuria). Tx w/steroids & plaquenil. 10/24/08 Reviewed rheumatology clinic records of 4/1/08 & hospital medical records of 7/23-7/25/2008. No other records available. FINAL DX: mixed connective tissue disorder w/SLE Records reveal patient had initially been seen in rheumatology clinic on 3/18/08 & dx w/SLE. Tx w/steroids, plaquemil & ASA for rash & (+)ANA. Improved by 4/1 visit w/only minimal pain in distal fingertips. Had been seen by ophthalmology 3/22/08 & exam WNL. Exam on 4/1 revealed slightly enlarged but nontender inguinal lymph nodes, hyperpigmented plaques on face, upper arms, axillae, vasculitic rash on palms, plinter hemorrhages in distal fingermails. Dx at that time: SLE w/discoid rash, elevated muscl" "Unknown PMH: autoimmune thyroid disorder. Family hx: renal failure, HTN.""LABS: Urine protein >300(H). ANA 1.2360(+). ESR 23(H). PAP abnormal w/PCR (+) for gonorrhea & HPV/CIN I. CRP 0.11, AST 69(H), serum albumin 3.4(L), complement 3-38(L), complement 4-3(L). Plts 584K(H), AST 320(H), ALT 475(H), cardiolipin" . During the same period patient was treated with Unknown. Patient was hospitalized Patient recovered.

HPV (GARDASIL) Side Effects Report #323723
HPV (GARDASIL) vaccine side effect was reported on 08/26/2008. Female patient, 20.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: White blood cell count increased, "7/07 Severe headaches going from neck to front of head and eye socket, numbness, muscle weakness, difficulty work mostly left leg. Problems with sight. 9/04/2008 Pt seen 5/1/2007 for 3rd HPV. Pt c/o R middle finger and ankle swelling. 11/3/2008 MR received from neurologist which includes H&P and consult for admission 9/27/08 for intractable headache, agitation, sweating, photophobia, low grade fever. Admitted to r/o meningitis. DTRs 3+ in upper extremities, decreased sensation on L side. 12/16/2008 Additional records received. DX: Severe h/a as adverse effect of steroids. Pt developed loss of vision of L eye in summer 2007 and given dx of MS. Had been started on Solumedrol for MS exacerbation and developed severe h/a with photophobia unrelieved by pain meds. PE (+) for decreased sensation in the L face and extremities, DTRs elevated in upper extremities. Pt agitated with labile emotions. Admitted for o/n observation." Asthma; Endometriosis. PMH: endometriosis"Test - MRI - 7/08 diagnosed M.S. Spinal taps. Labs and Diagnostics: CBC with WBC 14.8 (89% segs, 6% lymphs), RBC 3.74, Hgb 11.9, Hct 35.1. Total protein 5.9. Albumin 3.1. Alk Phos 35." . During the same period patient was treated with Albuterol; Birth control pills. Patient was hospitalized Patient recovered.

HPV (GARDASIL) Side Effects Report #323865
HPV (GARDASIL) vaccine side effect was reported on 07/30/2008. Female patient, child 11.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: White blood cell count increased, "In December of 2007 and January of 2008, patient became withdrawn and concerned that she did not lose weight despite diet and exercise, and she started having opsoclonus. She had no illnesses around the time of onset of those symptoms. Brother had been quite ill (thought initially to be meningitis, but turned out to be unknown) and is now better. She had a meningitis vaccine and HPV vaccine at the time that she started to be withdrawn. Over the course of 1-2 weeks she became ataxic, and had very ~jumpy arms~. This myoclonus spread to her legs such that she could not walk. She denied headaches, nausea, and or vomiting. No muscle aches or leg pain. No tinnitus or hearing loss. At the time of a February 11, 2008 admission she had severe opsoclonus, myoclonus, dysmetria, and perhaps a wide amplitude tremor. An extended evaluation was started looking for a neuroblatoma and a ganglioneuromal, mitochondrial disease, inflammatory diseases, and other diseases. There were a few abnormal lab results, which normalized later. The lactate normalized only after starting mitochondrial vitamins. No evidence of a ganglioneuroma or neuroblastoma was found. Blood mitochondrial mutations were sent and later returned as normal. Because the lactate was high, we added Thiamine 25 mg twice daily and riboflavin 50mg twice daily, CoQ, and Keppra was started later at 1mg/kg/day, and advanced as tolerated, then lowered when she started feeling nauseated. She received steroid x 1 week courses, with marked hyperglycemia, but no improvement. She received IVIG, then sent to hospital. She was discharged from hospital with improved opsoclonus, but still unable to walk or reach easily. She returned to hospital for a second course of IVIG. After that, the mitochondrial meds were stopped, she remained unable to walk, and had variable but usually less opsoclonus. Physical therapists noted some weakness and atrophy, and she had one episode when she would fall to the left side when the tuning fork was put near her left ear. She had" None"History derived from review of medical record, several of my prior exams and visits, and discussion with PCP; Seasonal allergies.' PMH: Asthma. Allergic to Augmentin and Benadryl.""Blood lactate 6.6, followed by 5.4 both in free flowing blood, without tourniquet; Pyruvate, requested but not obtained; CPK 103; Blood mitochondrial mutations, normal 14 mutations and 3 deletions, including MERRF mutations; Urine spot HVA:" . Patient was hospitalized Patient recovered.

HPV (GARDASIL) Side Effects Report #323987
HPV (GARDASIL) vaccine side effect was reported on 08/13/2008. Female patient, child 12.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: White blood cell count increased, "Was in sitting position; fell onto mother 3 minutes after shots. Jerking movements of both upper limbs, rigidity of body; lasted 30 seconds; then asked what happened" NoneNoneCBC and Comprehensive Metabolic Panel done (see results). 08/13/2008; Random Glucose 100 mg/dL (70-110); Blood urea Nitrogen 8 mg/dL (7-18); Creatinine 0.6 mg/dL (0.6-1.0); Sodium Level 138 mEq/L (136-145); Potassium Level 4.0 mEq/L (3.5-5. . During the same period patient was treated with None. Patient recovered.

HPV (GARDASIL) Side Effects Report #324169
HPV (GARDASIL) vaccine side effect was reported on 09/04/2008. Female patient, 21.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: White blood cell count increased, "Headache, seizures, fever, dizziness, lupus like syndrome; Started - approximately 4 months after last injection, patient hospitalized several times placed in intensive care unit 11/17/08 records received-for DOS 7/27/08-admitted via ED for C/O abdominal pain for 5 days, no bowel movement in 5 days. Seen by PCP on 7/24/08 with no diagnosis. Seen 2 days prior in ED with negative workup. Signed out AMA. Notes for DOS 8/18/08-DX-Drug-induced lupus, questionable. Possible underlying systemic lupus. Viral syndrome, questionable viral encephalitis. Inflammatory renal disease. Myalgias with possible peripheral neuropathy. Possible reaction to vaccination. Anemia. Elevated erythrocyte sedimentation rate suggesting underlying inflammatory disease. Abdominal pain possibly secondary to renal inflammation. Presented with C/O abdominal pain, intermittent joint and neck pain and headache.Records for 8/30-9/02/08 DC DX: new-onset seizure activity. Possible benign vasculitis to inflammatory vasculitis. Possible cerebral infarct evolving nature with edema involving multiple areas of brain as per MRI. History of lupus positivity possibly drug induced lupus. Questionable viral meningitis with negative CSF. Generalized pain and fatigue. Peripheral neuropathy. Possible meningitis inflammatory nature. Renal failure with reversal. Normal creatinine. Transferred.12/8/08-records received for DOS 9/2-9/12/08-DC DX:PRES. Hypertensive Disorder. Presented with 2 month history of headahces, joint pains, and abdominal pain. Presented to ED 3 days prior with severe headache, vomiting and multiple generalized tonic clonic seizures. Headaches began end of June and diagnosed with sinusitis. Subsequently developed leg aches, wrist aches, joint stiffness and mild rash on legs. Extreme headache, double vision vomiting. Symptoms improved but developed severe stomach pains and constipation. Improved with Prednisone but symptoms began after Prednisone taper. Rheumatology thinks this is a vasculitis secondary to OCPs. Ophthalmology mild esophoria visib" noneSeasonal allergies"CAT Scan, Lab work 11/17/08-rcords received-negative CSF. CT negative. C-reactive protein elevated. Elevated erythrocyte sedimentation rate. Hypoalbuminemia. Positive lupus antigens. Possible cerebral infarct evolving nature with edema in" . During the same period patient was treated with 493 Oral Contraceptive. Patient was hospitalized Patient recovered.

HPV (GARDASIL) Side Effects Report #324498
HPV (GARDASIL) vaccine side effect was reported on 09/08/2008. Female patient, 23.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: White blood cell count increased, "I have received the 3 vaccines, first one 1-22-08,4-1-2008 and 8-21-2008 I became ill in February 2008, had bloody stools, diarrhea, nausea, cbc was done at that time i had a wbc of 13.0 a colonoscopy was done in April 2008 this was negative. i have had headaches(migraines) that have occured more often. I received my 3rd shot on 8-22-08 i had a bruise and swelling from this. I started to feel ill, lightheaded, nausea and vomiting as well as diarrhea and stomach pains times 1 week before , i ended up in the ER on 9-4-8 with excruitiating abdominal pain, painful urination. My WBC at that time was 17.5, my urinalysis was within normal limits and the CT confirmed an appendicitis. I had surgery that evening. 9/22/08-records received for DOS 9/4-9/5/08-DC DX: Appendicitis. Presented with C/O abdominal pain times one day and diarrhea times one week. Surgery, laparoscopic appendectomy." cbc with wbc of 13.0 done on 2/13/08 cbc with wbc of 17.5 on 9/4/08 CT scan with inflammed appendix 9/22/08-records received-WBC 17.0 and CT with a positive appendix. . Patient was hospitalized Patient recovered.

HPV (GARDASIL) Side Effects Report #324826
HPV (GARDASIL) vaccine side effect was reported on 09/10/2008. Female patient, 16.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: White blood cell count increased, "Information has been received from a physician assistant concerning her daughter who on an unspecified date was vaccinated with a second dose of GARDASIL (lot number, injection site and route not reported). Three weeks after the vaccination, the patient experienced paralysis. The patient had to quit the volleyball team because her walking was effected. The patient underwent ~a full work up~ that was negative for any medical reason for the paralysis. Therapy with HPV was discontinued. The event was transient in nature and completely resolved in four weeks. It was reported that the patient completed the series of GARDASIL last year. Upon internal review, paralysis is considered to be an other important medical event. Additional information has been requested. 9/19/08 Reviewed PCP #2 medical records of 10/10/07-6/26/08. FINAL DX: viral syndrome & polyarthralgia Records reveal patient experienced morning joint pain & stiffness & swelling of hands & feet for approx 2 wks prior to 10/10/07 visit. Had cold s/s prior to symptoms start. Received HPV #2 on 3/21/08. 5/5/08 Had finger laceration w/nerve & tendon involvement & was referred to ortho/hand surgeon, required surgery. Received HPV #3 on 5/22/08 but no Lot # provided. Seen 6/26 for sore throat, nausea, malaise, fatigue, decreased appetite, body aches & fever x 1 day. Tx w/ antibiotics for sinusitis & pharyngitis." "Unknown PMH: acne. HPV#2, given 3/21/08, Lot #1757U. HPV#3 given 5/22/08, no Lot # available.""diagnostic laboratory - negative LABS: 10/11/07 CBC w/neutros 74%(H), lymphs 25%(L), monos 1%(L). RA factor 3.1(N). ESR 8(N). UA WNL. EBV neg. 5/6/08 CBC, chemistry WNL. 6/26/08 WBC 13.0(H), Grans 89%(H), lymphs 8.0(L), mono 3.0%(L" . During the same period patient was treated with unknown. Patient recovered.

HPV (GARDASIL) Side Effects Report #325063
HPV (GARDASIL) vaccine side effect was reported on 09/12/2008. Female patient, 17.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: White blood cell count increased, "Information has been received from a physician concerning a 17 year old female with acne who on 24-JUL-2008 was vaccinated with the first dose of GARDASIL. Concomitant therapy included erythromycin, solution, topical. On 04-AUG-2008, the patient experienced abdominal pain, chest pain and aching everywhere and was hospitalized. On 05-AUG-2008, the patient experienced myocarditis and died. Diagnosis was myocarditis but the doctor said it was not related to GARDASIL. The last time she was seen in this office was 2005. No additional information at this time. Additional information has been requested. 10/01/08 Death certificate states COD as myocarditis & CHF as contributing factor. 9/22/08 Reviewed PCP medical records. Reveals patient experienced abdominal pain, chest pain & aching everywhere. Expired 8/5/08 w/viral infection of the heart. Concomitant med was erythomycin topical solution for acne. Patient noted to be in good health on day of vaccination. 4/2/09 Received hospital medical records for 8/3-8/4/2008. FINAL DX: deceased secondary to severe nonischemic cardiomyopathy secondary to viral myocarditis Records reveal patient experienced fever, chills, feeling unwell x 2-4 days. Presented to ER w/abdominal & chest pain, weakness, dizziness, hypotensive, tachycardia, SOB, respiratory distress w/hypoxemia, azotemia, shocklike symptoms. EKG w/diffuse ST changes & ST elevations. Dx w/acute anteroseptal MI Emergent cardiac cath revealed EF 23% & balloon pump placed. Intensive care, deteriorated, V-tach, decompensation, extensive resuscitation efforts failed." Acne"Unknown LABS: WBC 10.3(H). Troponin greater than 100(H) & CPK 5492(H), CKMB 313.1(H) c/w infectious myocarditis, possibly viral. TSH 0.09(L). CRP 38.3(H). BNP 533(H). ANA neg. ASO 200(+). CXR abnormal w/water bottle appearing hea" . During the same period patient was treated with erythromycin. Patient was hospitalized Patient died on 4//08/08/0.

HPV (GARDASIL) Side Effects Report #326530
HPV (GARDASIL) vaccine side effect was reported . Female patient, 18.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: White blood cell count increased, "Nov 07 till recent symptoms, headaches, fatigue, vomiting, dizziness, back and neck pain, weight loss, rash, nausea. Signs-jerking, dropping things confuse-seizures treatment-emergency room stay in hospital overnight. Diagnose with epilepsy, now on medication. 10/28/08 Reviewed hospital medical records of 08/18-08/19/2008. FINAL DX:juvenile myoclonic epilepsy Records reveal patient had initial convulsive seizure on 8/18/08 but had been experiencing myoclonic jerks x 2 years prior along w/brief episodes of speech loss. 11/4/08 Reviewed neurology medical records of 9/4/08. FINAL DX: seizure disorder, partial Records reveal patient had 'jerking episodes' of arms & head for approx 8 mos. Developed generalized tonic-clonic seizure, bit tongue & was confused & disoriented afterward. No further seizures while on medication." nausea"No PMH: Contraception, genital herpes, chlamydia trachomatis. Smoker. Allergy: ibuprofen. PMH: family hx of epilepsy.""Epilepsy LABS: EEG abnormal. WBC 12.8(H), absolute lymphs 4.5(H), absolute monos 1.0(H). Potassium 3.0(L), carbon dioxide 12(L), anion gap 26(H), albumin 5.3(H). Cannabis (+). CT of brain WNL. Prolactin level (H). Valproic acid 61(N" . Patient was hospitalized Patient recovered.

HPV (GARDASIL) Side Effects Report #326876
HPV (GARDASIL) vaccine side effect was reported on 10/02/2008. Female patient, child 12.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: White blood cell count increased, "2/28/06 - Unconscious episode - Dx s/p concussion. 3/30/06 - Evaluated lightheadedness. 5/24/07 - Evaluated with syncope episode. 8/22/07, 10/22/07, 2/21/08 received GARDASIL. 8/22/07 - 2/21/08 received HEP A. 7/3/08 Evaluate syncope. 9/11/08 Mom states seizure disorder - requests form. 10/06/2008 PCP records received. Pt with several year hx of intermittant dizziness, lightheadedness, headaches and tunnel vision s/p concussion. W/u have been (-) thus far except iron deficiency anemia-treated. Most recent recorded incident 5/07 with low blood sugar. Seen 7/3/08 in F/U of ER visit for syncopal episode. Pt reported feeling weak prior to incident then pt's eyes rolled back and had jerking movements. Pt remained semi-conscious. Likely dx: Vasovagal Syncope. Referred for Echo and EEG. 1/16/2009 MR received for DOS 6/26/2008 with DX: Syncope. Pt presented after episode of dizziness and syncope with loss of consciousness while having an abrasion from a fall cleaned. Pt has appeared pale x several days. PE WNL exept for superficial abrasions. Assessment: Spell, 2' to vasovagal from pain." NoneNone. PMH: none"EEG, CBC with Diff, Echocardiogram, MRI Labs and Diagnostics: CBC with WBC 12.2. Echocardiogram WNL. EEG WNL." . During the same period patient was treated with None. Patient recovered.

HPV (GARDASIL) Side Effects Report #327041
HPV (GARDASIL) vaccine side effect was reported on 10/04/2008. Female patient, 14.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: White blood cell count increased, "patient has syncope episode s/p administration. Patient has numbness of nose and mouth beginning 2 days s/p vaccine 10/14/2008 Reviewed PCP office records of 9/29- FINAL DX: numbness of skin, vaccine adverse reaction Records reveal patient came into office w/numbness of nose & lips x 4 days starting 2 days s/p #2 HPV vaccine. Stated that had immediate syncope s/p #1 HPV vaccine received 6/30/08. Referred to neuro but no records available." NoneNone Known PMH: acne"LABS: 6/30 WBC 12.0(H), Hct 36.5(L), urine c/s neg." . Patient recovered.

HPV (GARDASIL) Side Effects Report #327096
HPV (GARDASIL) vaccine side effect was reported on 10/02/2008. Female patient, 20.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: White blood cell count increased, "Information has been received from a 20 year old female consumer, for the Pregnancy Registry for GARDASIL, concerning herself, who in October 2007, was vaccinated with a dose of GARDASIL, injection. In April 2008 the patient received a third dose of GARDASIL. Concomitant therapy included vitamins (unspecified). Subsequently, she became pregnant, and the last menstrual period is 11-MAY-2008. The patient had blood work performed several times during her pregnancy, results not reported. On 17-SEP-2008, the patient's placenta ruptured. The patient experienced a blood clot between her uterus and placenta, a tear in her placenta and her umbilical cord was partially attached on the side. The baby was delivered, was too small and died. The patient was hospitalized for a day after giving birth. Additional information has been requested. 3/10/09 MR received for DOS 9/17-18/2008 with D/C DX: Premature ROM. Previable fetus. Marginal abruption. SVD. Pt presented at 19 wks of pregnancy with cramping, vaginal bleeding and rupture of membranes. Non-viable fetus delivered. Pt had retained products of conception tx with D&C. Unremarkable post-op course." Pregnancy NOS (LMP = 5/11/2008)PMH: PCOD. NKDA.hematology. Labs and Diagnostics: surgical pathology report for markedly disrupted placenta. Fibrinogen (H) 653. CBC with WBC 27.0. Hgb 11.9. Hct 33.9 down slightly after delivery. UC (-). GC and Chlamydia (-). . During the same period patient was treated with vitamins (unspecified). Patient was hospitalized Patient recovered.

HPV (GARDASIL) Side Effects Report #327112
HPV (GARDASIL) vaccine side effect was reported on 10/03/2008. Female patient, 14.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: White blood cell count increased, "Information has been received from a pharmacy technician concerning her 14 year old female daughter with no previous medical history reported who in May 2007, was vaccinated with the first dose of GARDASIL and in July 2007 was vaccinated with the second dose of GARDASIL. There was no concomitant medication. The patient received the second dose of GARDASIL and about one week later she woke in the middle of the night. The patient's lips and ears were swollen and her whole body was red. The patient then developed diarrhea and projectile vomiting followed by chills that caused her whole body to shake. The whole episode lasted for about one hour to one and one half hour. The patient has had 6 similar ~bad~ reactions, the worst was in January 2008. The patient has had numerous ~moderate~ reactions (at least 6 in 2008) which involved diarrhea, vomiting or nausea. The patient has also sought treatment for continual menstrual bleeding since September 2007 that was treated with hormones (birth control). The patient was hospitalized in September 2007 for dehydration. The patient experienced nausea and felt like she was going to pass out on 22-Sep-2008. She has also experienced breathing difficulty (EPI PEN) and was starting to be emotionally effected (wanted to be by herself). The patient never received the third dose of GARDASIL. Numerous blood tests and unspecified tests were performed (resulted were not provided). There was no product quality complaint. As of 29-SEP-2008; the patient was not recovered. Lips and ear swelling; whole body red, diarrhea, vomiting, chills, nausea, going to pass out, continual menstrual bleeding, breathing difficulty and emotionally affected were considered to be disabling by the pharmacy technician. Breathing difficulty requiring EPI-PEN was considered to be an other important medical event by the pharmacy technician. Additional information has been requested. 10/10/08 Reviewed ER records of 8/9-8/10/2007. FINAL DX: acute allergic reaction, vomiting & diarrhea Records reveal patient exp" "None PMH: contraception, acne, pneumonia. Allergy: ragweed. Family hx: DM, heart disease, CVA, cancer.""Unknown LABS: WBC 18.3(H), neutros 74.9%(H), chemistry WNL. prolactin 17.2(H). EKG WNL." . During the same period patient was treated with None. Patient was hospitalized Patient recovered.

HPV (GARDASIL) Side Effects Report #329214
HPV (GARDASIL) vaccine side effect was reported on 10/20/2008. Female patient, 17.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: White blood cell count increased, "Patient received Gardasil around 8/1/08 in left arm. While attending a forum for high school students, she presented to ER on 10/19/08 with left arm swelling and pain. Ultrasound demonstrated LUE DVT, and CT of chest showed small pulmonary emoboli. Only other risk factor for DVT is birth control pills. 12/04/08-records received for DOS 10/19-10/23/08-DC DX:Left upper extremity deep venous thrombosis with a few very small pulmonary emboli identified in right lung as well on chest computerized tomography. Transient orthostatic hypotension. Thoracic outlet syndrome on left likely contributing to deep venous thrombosis. Oral birth control pills started within last 4-6 months-now discontinued. Presented to ED with acute swelling of left upper extremity. 2/26/09-office visit note for DOS 8/26/08 received follow-up visit for dysmenorrhea now improved." 12/4/08-records received-Family history notable for upper extremity deep venous thrombosis."CT chest on 10/19/08 showed several small pulmonary emboli. Ultrasound of left upper extremity, 10/19/08, showed extensive DVT. 12/4/08-records received-Ultrasound showed extensive deep venous thrombosis. WBC 13.4 84% neutrophils 11% lymp" . During the same period patient was treated with Birth Control Pills. Patient was hospitalized Patient recovered.

HPV (GARDASIL) Side Effects Report #331142
HPV (GARDASIL) vaccine side effect was reported on 11/03/2008. Female patient, 16.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: White blood cell count increased, "Patient developed arthralgias, change in mental status. Diagnosed with Systemic Lupus Erythematous on 10/23, based on +ANA and +dsDNA. Admitted to Hospital for changes in mental status, thought to be from lupus cerebritis. records received 11/14/08-presented to ED 10/28/08-C/O short term retrograde amnesia. Intermittent blurry vision. C/O joint pain, headaches nausea for 4 weeks. Left hand weakness. One and half months prior C/O pain in hands and feet, isolated papules. Difficulty sleeping. 12/1/08-DC summary received for DOS 10/28-11/6/08-DX:Lupus cerebritis. Change in mental status." nonenone 11/14/08-records received-PMH: recent diagnosis of lupus last week on prednisone."11/14/08-records received-ANA positive. CT sinusitis. MRI consistent with lupus cerebritis. Echocardiogram normal. WBC 22.4, absolute neutrophil count increased 18.82, ESR increased 87, CSF glucose low 59, oligo bands albumin , serum 3330" . During the same period patient was treated with OCPs. Patient was hospitalized Patient recovered.

HPV (GARDASIL) Side Effects Report #331253
HPV (GARDASIL) vaccine side effect was reported on 11/04/2008. Female patient, 16.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: White blood cell count increased, "Fever, adominal pain and emesis .started 6 days after last dose of Gardasil.progressed to jaundice and dehydration. MANUFACTURER MERCK. 11/12/2008 MR received for DOS 10/23-11/4/2008 with D/C DX: Superior mesenteric venous thrombosis. Direct hyperbilirubinemia. Hyponatremia, Hypokalemia, Acute Renal Insufficiency, Thrombocytosis, Anemia (iron deficiency). Pt presented with a 1 week hx of fevers, emesis, decreased po intake, appetite and urine output, abdominal pain and one episode of diarrhea. Pt noted to be dehydrated and icteric on admission. On PE abdomen noted to be distended with some tenderness in the RuQ and epigastric regions. Started on Lovenox, coumadin, and abx. No resolution of thrombus but no further extension. LFTs improved. Creatinine improved with hydration. D/C for continued outpt f/u." nonenone. PMH: none."Ct scan positive for a superior mesenteric vein thrombosis. Labs and Diagnostics: CBC with WBC 14,200, Hgb 9.7, MCV 76. Ferritin high. AST 81. ALT 57. Creatinine 1.34. Alk Phos 306. Bilirubin total 6.6. Bili direct 4.4. GGT 161. Albumin" . During the same period patient was treated with none. Patient was hospitalized Patient recovered.

HPV (GARDASIL) Side Effects Report #331290
HPV (GARDASIL) vaccine side effect was reported on 11/04/2008. Female patient, 13.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: White blood cell count increased, "Hives like rash at day 3-4D, Fever day 5, Joint and muscle pain debilitating by day 5, Admitted to hospital 10-28-08. WBC 32,000, ESR 70 - 124, CRP 7.3. 1/26/09 Reiceived hospital medical records for 10/28-10/31/2008. FINAL DX: not available on d/c summary available Records reveal patient experienced migratory joint pain, fever & migrating pruritic rash. Had recent strep throat. Tx w/IV antibiotics, NSAIDS & antihistamines. Improved by d/c to home on continued oral PCN & w/outpatient cardio & rheum consults. 2/3/09 Received Rheum & ID consults. Rheum consult of 11/14/2008: FINAL DX: arthritis, carditis, fever, ?Still's disease Records reveal patient exp (+)GABS 10/26 after rash developed on 10/24. Rash has waxed & waned since. Remained on PCN & NSAID. Exam revealed swollen wrists w/decreased ROM. Labs & x-rays ordered. Patient was being f/u by cardio. ID consult of 11/18/2008: FINAL DX: fever, arthritis, rheumatic fever doubtful Records reveal review of extensive medical records w/o definitive diagnosis. Referred back to cardio & rheum clinics." NoneNone PMH: sibling w/(+)GABS 10 /18"ASO (-); Blood culture (-); RF (-); (+) Rapid test for strep; Many others LABS: Urgent care labs of 10/10/26/08: WBC 38,300, PMNs 92%. ESR 70(H). Hospital labs of 10/28-31/08: WBC 31,900, PMNs 93%. ESR 124(H). CRP 7.3(H). ASO neg." . During the same period patient was treated with None. Patient was hospitalized Patient recovered.

HPV (GARDASIL) Side Effects Report #331407
HPV (GARDASIL) vaccine side effect was reported on 11/05/2008. Female patient, 26.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: White blood cell count increased, "Fainting, left sided weakness and tingling, double vision for 3 months, prolonged fatigue, rigors, hypersensitivity, unsteady gait. All symptoms continue to persist. Placed on steroids on and off for three months. 11/20/08 Received GYN office records of 3/24-10/06/2008. FINAL DX: none provided Records reveal patient had fibrocystic breasts on 3/24 & BCP changed. US of breasts reviewed & WNL. T/C 6/26 pt reported having been seen in ER x 2, ENT, Neuro & had EEG, CT scan & MRI. Had faint feeling, numbnness in feet, visual changes x 1.5 mo. RTC 10/6/08 12/8/08 Received ER medical records of 5/1/2008. FINAL DX: pre-syncope & palpitations Records reveal patient experienced intermittent pre-syncope & palpitations x 3 weeks now with same plus tingling around mouth & hands, nausea x 2 wks, dizziness. No symptoms while in ER & d/c to home w/PCP f/u. 2/2/09 Received hospital clinic records for 6/25-8/8/2008. FINAL DX: none provided Records reveal patient w/lightheadness, fatigue, multiple episodes of felt faint, tachycardia, hand tremors, feeling foggy, intermittent tingling & weakness of legs, vision abnormal since 3/08 shortly after received HPV #1. 2/3/09 Reeived ENT medical records of 5/8/2008. FINAL DX: resolving sinusitis Records reveal patient experienced sinus infection s/s x 3 weeks of nasal congestion, malaise, HA, rhinorrhea, facial pain/pressure & dizziness. 2/9/09 Received ER medical records of 4/14/2008. FINAL DX: dizziness, etiology unknown Records reveal patient experienced dizziness & felt faint x 5 days. D/C home w/neg exam." none"asthma (seasonal) PMH: dysmenorrhea, contraception, asthma, hypercholesterolemia, pneumonia, allergic rhinitis,sinus infection, GERD, ovarian cysts. Off contraception x few mo. Needle stick from HIV+ patient in 12/2007, meds x 2 mo, own HIV test neg. Family hx: MS."2 ER visits due to near syncope. All lab tests negative. MRI and CT of the head negative. EEG negative. Retnal specialist exam negative as well as ENT scope negative. LABS: 2006 PAP smear abnormal w/inflammation; PAP smears WNL since. ECG . During the same period patient was treated with none. Patient recovered.

HPV (GARDASIL) Side Effects Report #331949
HPV (GARDASIL) vaccine side effect was reported on 11/11/2008. Female patient, 22.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: White blood cell count increased, "Patient had stayed up from working MN's and went to doctor to receive final HPV vaccine. Had been feeling 'fine' --other than the normal post MN feeling. Had the injection administered about 12:30 pm--went home had something to eat, then went to bed. awoke about 5:00 pm this same day, with a headache, low grade fever, achiness, neck pain , and abdominal discomfort. temperature at @ 6 pm = 99.2 orally.pt took advil x 1. went to work at 9 pm this same day. started to feel much worse, increased fever, headache, and neck pain and 'feeling just run down all over'. patient could not work her mn shift, and was going to be escorted home. pt works in an Ed department and upon arrival of parents to pick her up, pt had an syncopal episode, pallor skin --almost white, with mild tremors. pt required stat ed care, which included a ct, lab, ivf (pt very dehydrated) required 3 liters of fluid, hr =tachy with low bp. spinal tap was done to r/o meningitis. pt 's lab revealed wbc with slight elevation. other labs wnl. temperature spiked to 102.5 rocephin iv given, and cultures drawn. pt started to feel better, after antipyretics , ivf's, and comfort/ sleep. discharged to home after 7 hours in the ed. pt remains with mild --cluster type headache controlled with pain medication. final dx= ? viral meningitis. 11/19/08-records received-final HPV4 vaccine received on-11/5/08-C/O headache, fever, neck pain, abdominal discomfort. General malaise and pale. Passed out. Dehydration. Diagnosed with viral meningitis and discharged from ED. Continues to C/O mild headache and tiredness and slowly progressing. No C/O with 2 previous HPV4 vaccines." none that we are aware ofnone"11/19/08-records received-Seen in ED performed CT scan, lab work and spinal tap. WBC mildly elevated. Initial spinal fluid negative, culture both serum and spinal negative." . Patient recovered.

HPV (GARDASIL) Side Effects Report #334962
HPV (GARDASIL) vaccine side effect was reported on 11/14/2008. Female patient, 17.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: White blood cell count increased, "Information has been received from a nurse concerning a 17 year old female who on an unknown date was vaccinated with the first dose of GARDASIL. In the morning of 29-OCT-2008, the patient was vaccinated with the second dose of GARDASIL. The nurse reported that the patient was fine after the first vaccine. On 29-OCT-2008, 5 to 10 minutes after vaccination the patient left the office to go to school. The patient passed out while she was driving and got into an accident. The nurse stated that the patient sounded fine on the phone but she went to ER for check up. Initial and follow up information has been received from a nurse and medical records concerning a 17 year old female who on 27-AUG-2008 was vaccinated with the first dose (lot # 659184/0843X), intramuscularly to the left deltoid. The nurse reported that the patient wsa fine after the first vaccine. In the morning of 29-OCT-2008, the patient was vaccinated with the second dose of GARDASIL. On 29-OCT-2008, 5 to 10 minutes after vaccination the patient left the office to go to school. The patient passed out while she was driving and got into an accident. The nurse stated that the patient sounded fine on the phone but she went to ER for check up. Follow-up information obtained from medical records reported that the patient was driving her car from the clinic where she had just received her GARDASIL injection. About 15 minutes latre she ~passed out~ and atruck the vehicle in front of her while traveling approximately 25 miles per hour. The patient states she felt dizzy and then the next theing she rememberd is waking up and seeing that she had hit the car in front of her. The patient was restrained and the air bags deployed. The patient was complaining of moderate pain over the left side of the chest. Otherwise she denied any pain. She reported a mild headache. She denied any previous episodes. The patient had been evaluated in the emergency room 2 days priort for right upper quadrant pain which she reported had presently resolved. The patient denined feeli" Unknown"blood pressure, 10/29/.08, =40/8; diagnostic urinalysis, 10/29/08, >500; chest x-ray, 10/29/08, normal; head computed axial, 10/29/08, normal; electrocardiogram, 10/29/08, normal; abdominal sonogram, 10/29/08, normal; total heartbeat count," . During the same period patient was treated with Unknown. Patient recovered.

HPV (GARDASIL) Side Effects Report #333227
HPV (GARDASIL) vaccine side effect was reported on 11/24/2008. Female patient, 16.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: White blood cell count increased, "Information has been received from a physician concerning a 16 year old female with sickle cell disease who on 09-SEP-2008 was vaccinated in her right arm with PNEUMOVAX 23 (lot #657525/0554U). On 09-SEP-2008 the patient was also vaccinated in her left arm with MENACTRA and GARDASIL (lot # 660555/0279X). Shortly after the vaccinations, the patient developed pain and swelling on the right arm where she received the PNEUMOVAX 23. Unspecified medical attention was sought. The physician also reported that on 23-SEP-2008 the patient was hospitalized and at the time of reporting was still in the hospital. It was unknown if the cause of the hospitalization was the swelling on her arm. No further information was provided. Follow-up information was received from the physician. It was reported that the patient was vaccinated with the first dose of PNEUMOVAX 23 vaccine in her right deltoid at 10:53 am. The patient had no illness at time of vaccination. On 23-SEP-2008 the patient experienced bone marrow edema and pain crisis. Subsequently, the patient was hospitalized for 7 days. Laboratory tests included: X-ray and MRI of humerus. The patient recovered from bone marrow edema and pain crisis on an unspecified date. No further information is available. 12/29/2008 MR including hospital records received from PCP for DOS 9/23-10/1/2008 with DX: Sickle Cell Disease and R arm pain. Pt presented with hx of R arm pain following several vaccinations. Pain area includes R shoulder, upper arm, elbow, forearm, wrist and hand. Pt unable to move hand. MRI c/w sickle cell crisis." Sickle cell diseasePMH: asthma. Sickle Cell disease. Cardiomegaly"X-ray, of the humerus; magnetic resonance, of the humerus. Labs and Diagnostics: X-ray arm (-). X-ray humerus (+) for widening of acromioclavicular joint. MRI arm (+) for bone marrow edema c/w sickle cell crisis and acute marrow infarctio" . Patient was hospitalized Patient recovered.

HPV (GARDASIL) Side Effects Report #334323
HPV (GARDASIL) vaccine side effect was reported on 11/17/2008. Female patient, 22.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: White blood cell count increased, "12/18/07 given 1st GARDASIL vaccine. 2/15/08 admitted to hospital with sudden onset lower extremity weakness unable to walk resolved w/in 24 hours. Neurological w/u revealed benign brain cyst & working diagnosis is seizure. Parents told by Neurologist could have been caused by GARDASIL. 2/27/09-records received presented to ED 2/14/08 with C/O 3 days of leg weakness and 1 episode of urinary incontinence at bedtime and mild CP. Occasional infrequent headaches. Impression: Benign brain cyst. 5/15/09 Medical records received DOS 2/15/08 to 12/11/08 FINAL DIAGNOSIS: Arachnoid cyst, seizure disorder Post vaccination: seizure. chest pain, unable to wake up, weak legs/arms, legs give way and falls, foot drop, numbness and tingling in feet, incontinant -waking up soaked, seizures, insect bite with rash under chin." Back Pain"Mild Scoliosis 5/15/09 Medical records received DOS 2/15/08 to 12/11/08 gastric ulcer, SI joint injury, tosillectomy and adenoidectomy, allergies to codeine amoxicillin, Zithromax."EEG-WNL; MRI; CT; EEG; saw Neurology and Neurosurgery. 2/27/09-records received-MRI brain abnormal showed right frontal lobe cystic mass. 5/15/09 Medical records received DOS 2/15/08 to 12/11/08 LABS and DIAGNOSTICS: MRI brain - beni . During the same period patient was treated with None; Given Rxs for Flexeril/ Mos. Patient was hospitalized Patient recovered.

HPV (GARDASIL) Side Effects Report #335142
HPV (GARDASIL) vaccine side effect was reported on 12/11/2008. Female patient, 23.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: White blood cell count increased, "Information has been received from a physician concerning a 23 year old female with no allergy or medical history who on 02-JUL-2008 was vaccinated with the first dose of GARDASIL, 0.5ml, IM. Concomitant therapy included YASMIN. 2 days after the vaccination (on 04-JUL-2008) the patient developed pancreatitis. The patient was admitted to an unknown hospital on 04-JUL-2008 and was diagnosed with pancreatitis. The physician is unable to provide details of the hospitalization except that the patient was discharged fully recovered on 09-JUL-2008. The patient underwent abdominal ultrasound during hospitalization. The physician considered the pancreatitis to be immediately life threatening and disabling. Additional information has been requested. 1/20/09 Reviewed hospital medical records of 7/5-7/9/2008 FINAL DX: acute pancreatitis; recent Gardasil shot; use of BCP for contraception. Records reveal patient experienced abdominal cramping pain, diarrhea, vomiting, fever after light ETOH consumption day prior to admit. GI consult done. Tx w/IVF & kept NPO. Improved & d/c to home w/PCP f/u." None"Unknown LABS: CT abdomen abnormal w/peripancreatic edema & free intraperitoneal fluid. US of abdomen WNL. Lipaase 209 (H). Amylase 304 (+). WBC 13,700(H). LFTs WNL. Blood c/s neg. Urinalysis WNL." . During the same period patient was treated with YASMIN. Patient was hospitalized Patient recovered.

HPV (GARDASIL) Side Effects Report #335218
HPV (GARDASIL) vaccine side effect was reported on 12/12/2008. Female patient, 20.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: White blood cell count increased, "high fever, delerious, syncope, dizziness, headache, hematuria, abdominal pain, neck pain, light sensitivity, shaky, nausea 2/12/09 Received ER medical records of 12/11/2008. FINAL DX: abdominal pain, nonspecific; UTI, like pyelonephritis; mod dehyrdation Records reveal patient experienced fever, chills, arthralgias, myalgias, vomiting, abdominal pain, sore throat, cough, HA, lightheaded. Tx w/IVF, antiemetics, antihistamin & IV antibiotics for probably pyelonephritis. Improved & d/c to home on continued oral antibiotics & f/u w/PCP in am. 2/20/09 Received PCP medical records of 12/8-12/12/08 FINAL DX: UTI Records reveal patient experienced likely hormonal amenorrhea w/neg preg urine when seen 12/8/08. RTC 12/12 w/N/V, right flank/RLQ abdominal pain, eye sensitivity, fever, bone/joint pain, shaking chills, ear pain, neck pain, HA, dizziness, near fainting, delerious w/fever. Had been seen in ER for UTI on 12/11. To continue oral antibiotics & return if no improvement. No further records available." slight fever 99.0"pcn, vicodin, benadryl,droperidol PMH: iron def anemia, irregular menstruation;off BCP x several months.""LABS: WBC 10.8(H), neutros 77.5%, lymps 13.2%(L). Sodium 132(L). UA abnormal. Throat c/s neg. Urine preg neg." . During the same period patient was treated with none. Patient recovered.

HPV (GARDASIL) Side Effects Report #335340
HPV (GARDASIL) vaccine side effect was reported on 12/15/2008. Female patient, 23.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: White blood cell count increased, "Patient recieved 2 doses of gardasil, july 15th 2008 and sept 15th 2008. She was diagnosed with non-hodgkins lymphoma on 11-20-08. She had lymphadenopathy in the neck and anterior mediastinum. She is currently undergoing chemotherapy. I read articles about recepients of HPV vaccine developing lymphadenopathy. 1/23/09 Reviewed hospital medical records of 11/17-11/20/2008; 12/4-12/5; and 12/12-12/15/2008; same day stays on 12/10 & 12/17. FINAL DX: primary mediastinal large B-cell lymphoma, Murphy stage III. Records reveal patient experienced left supraclavicular lymphadenopathy x 10 days beginning 11/7 along w/intermittent diarrhea & abdominal pain x 1 mo. Surgery & cardio consult done. Returned to hospital 12/4 to have port placed for chemotherapy & diagnostic LP & also intrathecal methotrexate & steroids. Returned to hospital for chemo & f/u CT scan 12/10. Returned to hospital 12/12-15 for chemo. Returned to hospital 12/17 for LP w/intrathecal chemotherapy." NONE"NONE PMH: family hx: lung cancer, brain tumor.""Lynphnode biopsy consistent with primary mediastinal large b-cell lymphoma. Pet scan, Ct scans also done localising the disease to neck and chest LABS: WBC 12.7(H), neutros 79.8%(H). ESR 39(H). Alk phos 105(H). Blood c/s neg. CXR abn" . During the same period patient was treated with NONE. Patient was hospitalized Patient recovered.

HPV (GARDASIL) Side Effects Report #335362
HPV (GARDASIL) vaccine side effect was reported on 12/14/2008. Female patient, 16.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: White blood cell count increased, "Patient likely conceived with pregnancy day of vaccine administration. Her pregnancy has been complicated by oligohydramnios at early as 16 weeks, and eminent concern for loss of pregnancy. 1/16/2009 ER record received for 12/7/08 with DX: Vaginal bleeding at 18 wks pregnant, anhydramnios, mid trimester ROM, 2 vessel umbilical cord, possible TGA in fetus. Prognosis poor. Pt presented with large amount of vaginal bleeding." NoneAmoxicillin allergy. PMH: allergy to amoxil"Labs and Diagnostics: Pelvic sono-no amniotic fluid. WBCs 10.4. UA with 4+ blood, 2+ leuk est, 10-20 WBC, >100 RBC, few bacteria. UC (+)." . During the same period patient was treated with None. Patient was hospitalized Patient recovered.

HPV (GARDASIL) Side Effects Report #335410
HPV (GARDASIL) vaccine side effect was reported on 12/16/2008. Female patient, 17.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: White blood cell count increased, "Patient received last of 3 Gardasil vaccinations. Approximately 2 months later was diagnosed with Hodgkins Lymphoma. Symptoms became evident just after the third vaccination. 3/9/09-records received-office visit 1/22/09-C/O tired SOB, Irregular menses which is secondary to chemo. Monitor labs if not better 3-6 mos. 4/29/09-records received-office visit 1/23/08 for C/O possible brachial cleft cyst or neck mass. Past 2 weeks swelling in left axilla. Decreased energy and generalized pruritus." NoneNone"Ultrasounds, chest xrays, ct and pet scans showed tumor growth. CBC out of normal range for months. 4/29/09-records received. WBC 30.1, lymph % 12.6, neut % 77. Biopsy of lymph node partial involvement Hodgkin lymphoma nodular sclerosis t" . During the same period patient was treated with None. Patient recovered.

HPV (GARDASIL) Side Effects Report #335521
HPV (GARDASIL) vaccine side effect was reported on 12/17/2008. Female patient, 23.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: White blood cell count increased, "Patient received vaccine and initially had soreness at the injection site for about 2 weeks. On 11/29 she noticed redness and warmth in addition to pain in the area. This initally improved without any treatment. Symptoms began to worsen again (redness, pain, warmth in the deltoid area of the arm) and she was seen at an urgent care facility on 12/9 and was given Keflex 250mg TID. Symptoms continued to worsen. She presented to the Emergency Department on 12/13/08 and was given a 1 gram dose of Vancomycin IV and was ultimately discharged home on Keflex 500mg QID and Bactrim DS - 1 tab BID. Patient reports initial improvement after the antibiotic change but then symptoms again worsened and she returned to the ED on 12/16/08 and was admitted to the hospital for IV antibiotics with worsening erythema and pain. She is currently on vancomycin IV and Clindamycin IV was added today because symptoms are not significantly improving. There is no abcess associated with the cellululitis. Patient is still in the hospital- anticipated discharge date unknown. 2/2/09-records received for DOS 12/16-12/19/08 DC DX:Myositis/fascitis.Presented to ER with 6 week history of LUE cellulitis at which time received 3rd gardasil injection in left arm. After injection noticed army sore 1 week later with red ring around injeciton site and treated with oral antibiotics. LUE pain worsing and redness spreading, decreased ROM, fever feeeling lethergic/fatigued. Presented with chills decreased oral intake." NoneCodeine- reaction is rashWBC on 12/13 was 12.5 but on 12/16 (day of admission) was 7.0. All other labs are within normal limits. CT of arm on 12/13 was within normal limits but MRI with and without contrast of arm on 12/16 indicated: 1. EVIDENCE OF A FAIRLY DIFFUS . During the same period patient was treated with Sprintec. Patient was hospitalized Patient recovered.

HPV (GARDASIL) Side Effects Report #336226
HPV (GARDASIL) vaccine side effect was reported on 12/29/2008. Female patient, 20.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: White blood cell count increased, "Diagnosed with Myasthenia Gravis (autoimmune disease) 5/13/09 hospital records received DOS 11/25/08 to 11/27/08. FINAL DIAGNOSIS: Myasthenia gravis, viral meningitis Post vaccination droopy left eyelid, difficulty running, weak grip, mouth and jaw fatigue, diplopia, dizziness. Admitted for IVIG treatment. Headache, increased ptosis, upper and lower extremity weakness. Nausea, vomiting 5/14/09 Received Neuro medical records of 11/24/2008. FINAL DX: myasthenia gravis Records reveal patient experienced weakness x 2 mo starting w/left eyelid droop, then mouth weakness, arm heaviness, grip strength decreased, leg stiffness, difficulty arising from sitting position, diplopia, intermittent left lazy eye, mouth/jaw fatigue, tiredness, slurred speech, DOE, heartburn, difficulty chewing & swallowing, loss of balance, loss of memory, urinary frequency esp at night. Sent to hospital for CT, IVIG x 2 days, steroids. 5/18/09 Received PCP medical records of 10/21/08-2/25/2009. Records reveal patient experienced fatigue, dizziness, blurred vision, gen weakness, difficulty concentrating & memory retention difficulties x approx 1 mo when seen 10/21. Referred to Rheum. No further visits until 2/25/09 s/p myasthenia gravis. 5/18/09 Received medical records from Rheum but was only labs of 11/19/2008." NONE"Allergy to Penicillin PMH: oral contraception, TB 2005, ex-smoker, social drinker. Allergy: PCN, morphine. Family hx: high cholesterol; depression; Cushings syndrome."ANA Panel results were higher then normal. I had a blood test for acetylcholine receptor antibodies. Normal is .05 and below. My results were 64.o. 5/13/09 hospital records received DOS 11/25/08 to 11/27/08. LABS and DIAGNOSTICS: CT lac . During the same period patient was treated with YAZ. Patient was hospitalized Patient recovered.


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Source: VAERS
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