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Pallor 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:Pallor

HPV (GARDASIL) Side Effects Report #336382
HPV (GARDASIL) vaccine side effect was reported on 01/02/2009. Female patient, 15.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Pallor, Was in reception area immediately after injection of Gardasil and fell to floor and had full body twitching for 5 to 10 seconds. Was not observed falling. Mother had back to her while paying receptionist. No complete loss of consciousness noted. Has redness on right side of face and c/o of pain in right temple area. PERL. Pale. Skin warm and dry. Not involuntary of bodily functions. Full ROM and good grasp and answers commands appropriately. No prior Hx of medical conditions except anemia when younger. BP130/90. Pulse 88reg. Happened at 9:50am and ambulance arrived to take her to ER at 9:57am. Phone call from mother stating she was discharged to go home at 11:20am. NoneNKA; anemia when younger . During the same period patient was treated with Taking Birth Contol Pills. Patient recovered.

HPV (GARDASIL) Side Effects Report #336705
HPV (GARDASIL) vaccine side effect was reported on 01/07/2009. Female patient, child 12.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Pallor, "Dizziness, nauseous, ringing in the ears, paleness for about 10 minutes after the vaccine." . Patient recovered.

HPV (GARDASIL) Side Effects Report #336825
HPV (GARDASIL) vaccine side effect was reported on 01/08/2009. Female patient, 16.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Pallor, "after the vacc,pt c/o dizzyness,when seen pt looked pale and sweaty,pulse 55,bp 88/54,pt put on table at trendlenberg position felt better ,bp 99/69,pulse 82" . Patient recovered.

HPV (GARDASIL) Side Effects Report #336854
HPV (GARDASIL) vaccine side effect was reported on 01/07/2009. Female patient, 16.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Pallor, "Information has been received from a consumer concerning her 16 year old daughter with no medical history or drug allergies who on 06-DEC-2008 was vaccinated with the first dose of GARDASIL. There was no concomitant medication. Within 24 hours after vaccination the patient started experiencing pain and within 2 days she started vomiting. She was admitted to a hospital on 12-DEC-2008 (enzyme levels were over 800) and released on the 16th. The hospital determined it was pancreatitis. Multiple tests were performed in the hospital including CAT scan and ultrasound but the results were not provided. The patient was not fully recovered yet, however her mother stated that she was better and her enzyme levels were coming back to normal. Additional information has been requested. 3/16/09 Received PCP medical records of 7/31/08-2/13/2009. FINAL DX: acute on chronic pancreatitis w/strictures & pancreatic stones s/p stent placement; pancreas divisum; asymptomatic until 12/10/08. Records reveal patient experienced good health on 12/6/08 when received HPV #1 & flu shot. RTC 12/10/08 w/cough, cold s/s & chest/upper abdomen pain near diaphragm. Dx w/muscle strain & URI. RTC 12/12 w/continued upper abdominal pain w/vomiting, watery diarrhea, pale w/decreased bowel sounds, guarding & rebound. Sent to hospital for acute abdomen. RTC 12/17 s/p hospitalization w/resolving pancreatitis. 4/16/09 Received hospital medical records of 12/12-12/15/2008. FINAL DX: pancreatitis, etiology unknown Records reveal patient experienced progressively worsening epigastric pain x 5 days, N/V x 1 day. Seen by PCP & dx w/musculoskeletal pain. Continued to worsen &unable to walk or attend school. ALso had cold s/s during the week & multiple sick contacts. Surgery & GI consult done. Labs & PE improved & able to tolerate diet. D/C to home W/PCP & GI f/u." None PMH: Foreign travel 7/08. Family hx: IBS."Diagnostic laboratory, 12/12/08, enzyme levels over 800 LABS: CT scan & US abdomen abnormal w/pancreatic & common bile duct dilation & calcification of pancreatic head. MRI/MRCP abnormal w/dorsal duct syndrome, pancreatic stones & stric" . During the same period patient was treated with None. Patient was hospitalized Patient recovered.

HPV (GARDASIL) Side Effects Report #337133
HPV (GARDASIL) vaccine side effect was reported on 12/30/2008. Female patient, 16.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Pallor, "Within 5 mins of receiving HPV injection pt became pale, lightheaded, vision became black, diaphoretic. Had pt wheeled to obs. room- monitored pt for 20 min - full recovery - discharged to Mom care." NoNoNone . During the same period patient was treated with No. Patient recovered.

HPV (GARDASIL) Side Effects Report #337160
HPV (GARDASIL) vaccine side effect was reported on 01/13/2009. Female patient, 16.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Pallor, "PT RECEIVED GARDASIL, MENACTRA AND ADACEL IMMUNIZATIONS ON 01-12-09. AFTER INJECTIONS, PT GOT DIZZY AND PALE WHILE SITTING UPRIGHT IN CHAIR IN EXAM ROOM. PT SLUMPED DOWN, HAD A BRIEF LOC WITH MILD IRREGULAR JERKING OF EXTREMITIES THAT LASTED APPROX 10 SECONDS. + URINARY INCONTINENCE. PT WOKE STARTLED AND SURPRISED ASKING ~WHAT HAPPENED?~ THE EPISODE WAS WITNESSED BY DR. DR. DOCUMENTED ~THIS SEEMS TO HAVE BEEN A VASOVAGAL SPELL WITH A SUPERIMPOSED HYPOXIC SEIZURE.~" "PT PRESENTED TO OFFICE FOR A PHYSICAL. PT C/O BEING ~TIRED MORE SINCE CHRISTMAS~ WTH INCREASED SLEEPING DURING CHRISTMAS BREAK""ALLERGIC RHINITIS, ALLERGY-INDUCED ASTHMA" . During the same period patient was treated with BENADRYL. 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: Pallor, "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 #337624
HPV (GARDASIL) vaccine side effect was reported on 01/18/2009. Female patient, 15.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Pallor, "Seizure activity, lower paralysis, exhaustion, nausea and vomiting, brain fog, difficulty concetrating, low blood pressure, Painful periods and off cycle, chest pain, joint pain, muscle pain and weakness, blurred vision, tremors, weight loss, personality change, dizziness, difficuly breathing, oxygen deprived, hair loss, Skin pale. 2/25/09 Received PCP medical records of 10/25/07-12/24/2008. FINAL DX: none provided Records reveal patient experienced good health on 10/25/07. RTC 11/15 w/sore throat, left ear pain & nausea x 1 wk. Dx w/viral URI. RTC 11/23/07 w/left knee pain/swelling x 5 yrs. Dx w/patellofemoral syndrome, tx w/meds & referred to PT. RTC 1/8/08 w/neck & throat discomfort. Dx w/voice weakness, probable strained cricopharyngial nerve. Tx w/meds & referred to ENT who dx w/dysphonia following likely vocal misuse. RTC 2/8/08 w/fatigue, upset stomach, weight loss, polydipsia & nausea x 1 wk. RTC 2/12/08 s/p fainting in school, lightheaded x 1 wk. Dx w/syncopal episode & possible dehydration, weight loss & fatigue. Tx w/IVF & meds. DM w/u neg. RTC 2/28 s/p ER visit for generalized pain. Had been hospitalized previous wk, dx w/pseudoseizure & followed by neuro. 3/27/09 Received Neuro consult medical records of 2/25-3/7/2008. FINAL DX: none provided. Consult states excessive tiredness, nausea & weight loss likely secondary to viral illness; intermittent weakness of legs posssibly due to dehydration vs presyncope; & recent onset of nonepileptic shaking events. Records reveal patient experienced fatigue during vacation out of state approx 3 wks prior to eval. Saw PCP after vacation for nausea, weakness. Hospitalized x 3 days. Eval by peds neuro at that time & dx w/syncope vs near syncope. Improved & d/c to home. Was able to return to school f/t & traveled out of state. Collapsed & had to be brought back home w/trembling of extremities. Admitted to hospital for further neuro eval. Exam & testing all WNL. D/C to home. Seen in ER x 2 for recurrence of shaking & aggressive behav" none"Allergy penicillin PMH: Asthma, strep throat.""PCOS LABS: video EEG, MRI brain & spine WNL. CPK WNL. Alk phos 51(L). PAP smear WNL." . Patient was hospitalized Patient recovered.

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

HPV (GARDASIL) Side Effects Report #337981
HPV (GARDASIL) vaccine side effect was reported on 01/22/2009. Female patient, child 11.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Pallor, Adolescent became lightheaded then fainted several minutes after receiving immunizations. LOC approx 1 min. and color pale. Remained nauseous and lightheaded 10 mins. Walked on own to parking lot accompanied by mother and nurse. Mother called 2 days later and stated adolescent fine after arriving home. . Patient recovered.

HPV (GARDASIL) Side Effects Report #338294
HPV (GARDASIL) vaccine side effect was reported on 11/26/2008. Female patient, 18.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Pallor, "After giving MMR patient eyes rolled back, Pt slumped and became unresponsive and dusky. O2 put on Pt after trying to revive and EMS called. B/P 54/30 - Hr 55 and resp. 12." NoneNone . Patient recovered.

HPV (GARDASIL) Side Effects Report #338602
HPV (GARDASIL) vaccine side effect was reported on 01/29/2009. Female patient, 14.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Pallor, "On 1/20/09 after clinic visit, and @ 7:30p felt dizzy, faint, sensitive to light and mom states pt. got really pale. Mom gave tylenol and went to sleep. When getting up this am, feels dizzy, faint when standing up headache enc to seek pmd care. Saw Dr. P/c attempted 4x's. No answer. 2/3/09 MR received from PCP for OV 1/21/09 for c/o dizziness, H/A and weakness x 1 day since receiving shots. Took first OCP that day as well. Reports light sensitivity, spinning sensation. PE WNL. Impression: Dizziness/ Vertigo. Suspected adverse reaction to either HPV or OCP. Tx: Meclizine" Acid Reflux . Patient recovered.

HPV (GARDASIL) Side Effects Report #338907
HPV (GARDASIL) vaccine side effect was reported on 02/03/2009. Female patient, child 12.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Pallor, "FATHER REPORTS CHILD DEVELOPED MIDABDOMINAL PAIN, DIARRHEA, AND VOMITED ONCE STARTING 1/23/09. IT BECAME INCREASINGLY WORSE AND SHE BECAME PALE ON 1/25/09. PARENTS TOOK HER TO THE EMERGENCY ROOM AND SHE WAS GIVEN IV FLUIDS, BLOOD TESTS, AND URINE TESTS. ALL TESTS WERE NORMAL. FATHER IS CONCERNED AS HE BELIEVES IT IS RELATED TO THE GARDISIL VACCINE. 2/23/09 Received ER medical records of 2/1/2009. FINAL DX: gastroenteritis Records reveal patient experienced nausea, vomiting, diarrhea, abdominal pain, fever, oral intake reduced, urinary frequency, dysuria, eye drainage, SOB, increased heart rate, weakness x 3 days. Patient had similar experience after initial HPV vaccine. Tx w/antinausea meds & IVF. Improved & d/c to home. 2/26/09 Received PCP medical records of 8/30/07-12/8/08. FINAL DX: epigastric pain, likely gastritis Records reveal patient experienced abdominal pain intermittently x several months when seen 12/3, 12/7 & 12/8/2008. Tx w/meds." NONENONE PMH: anxiety"LAB WORK, AND URINE TESTS LABS: CBC, BMP & UA WNL. Abdominal x-ray c/w constipation. CT abdomen/pelvis WNL. ER LABS: BUN 9(L), lipase & amylase WNL. neutros 69%(H)." . During the same period patient was treated with UNKNOWN. Patient recovered.

HPV (GARDASIL) Side Effects Report #339431
HPV (GARDASIL) vaccine side effect was reported on 02/10/2009. Female patient, 17.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Pallor, "1-2 minutes after receiving vaccine Pt. was getting ready to walk out the door with parent - and fainted - Able to keep standing and assisted into chair. Upon exam , NP noted mild diapheresis, Pallor, bradycardia. Responded with supine position and oral beverages. Discharged in stable cond. with limited activity x 24 hrs" None"NP exam, repeated vitals, no studies." . Patient recovered.

HPV (GARDASIL) Side Effects Report #339449
HPV (GARDASIL) vaccine side effect was reported on 02/11/2009. Female patient, 16.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Pallor, "Patient was in office for routine visit. Pt was ordered HPV vaccine, menactra (meningococcal) vaccine, and adacel (tdap) vaccine. Gave all three immunizations and right after giving the HPV vaccine, patient stating she felt like she was going to pass out. Patient leaned forward onto her mom while sitting on exam table and passed out, became very pale. Pt did not fall off table. Myself and another nurse immediately laid pt back on table. Pt awoke after only 1-2 seconds. We elevated pt's legs and had pt lay there while monitoring her for approximately 10 minutes. Pt was awake, alert, and oriented. At that time we gave her a small cup of orange juice and elevated pt's head. Pt laid there for approximately 10 more minutes and then we had the doctor check the pt. Pt was stating she was feeling fine, awake, alert, and oriented/walking around in room. Dr. gave the okay for pt to go home." none"no known allergies, no documentation of any birth defects or medical conditions"n/a . During the same period patient was treated with none. Patient recovered.

HPV (GARDASIL) Side Effects Report #339504
HPV (GARDASIL) vaccine side effect was reported on 02/12/2009. Female patient, 14.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Pallor, "After the third dose my daughter got very pale, sweaty, aand dizzy. The nurse and I layed her back on the exam table. She became unresponsive for 10-20 seconds and stayed laying down for about 10 minutes after that until she was no longer dizzy. My daughter started having heart palpitations after this and still has them today. Starting in February 2009, they are accompanied by chest pains. 4/8/09 PCP records received from 7/15/08 to 2/10/09. Seen for 14 yr WCC on 7/15/08 with c/o heavy periods. ROS (+) for headaches QOD. PE WNL with acne. Started on Concerta of ADD and OCs to regulate periods. Seen again 9/9/08 and 9/12/08 with c/o racing heart and irregular heartbeats associated with some anxiety. PE WNL. HR 95-105. Assess: Palpitations and/or tachycardia while on Concerta. Nausea from OCPs. Referred to cardiology for Holter. Returned 2/10/09 for c/o chest pain with skipped beats and feeling like the heart is beating hard. 4-6 episodes in last 2 weeks. Assessment: Likely precordial catch syndrome. Palpitations. Holter to be scheduled. 4/29/09 Received Cardiology medical records of 10/7/08-3/5/2009. FINAL DX: Palpitations Records reveal patient experienced palpitations w/chest pain & dizziness. Concerta had been d/c approx 1 mo prior to initial eval & palpitations had improved; however, patient needed to restart meds to maintain academic performance. When seen 3/5/09 palpitations had recurred while on Concerta esp when exercising. No further records available." None"seasonal allergies, ADD PMH: acne, irregular heavy menses, OCPs, headaches, palpitations x 2 yrs. Family hx: MVP."LABS: EKG & Holter monitor WNL . During the same period patient was treated with "Concerta 27mg, Fexofenadine 30mg, Flonase". Patient recovered.

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

HPV (GARDASIL) Side Effects Report #339570
HPV (GARDASIL) vaccine side effect was reported on 02/13/2009. Female patient, 23.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Pallor, "I received the Gardasil vaccine and walked out of the room. As I exited I lost vision and hearing and collapsed, still conscious and very nauseated. Difficulty breathing occurred once vision returned. Hearing did not return for 10 minutes and I heard a ringing, metallic sound every time I talked. Vision was yellow and green, and my face had lost all color (pale/green). 15 minutes after the shot I had abdominal cramps and diarrhea. I drank some water and was then freezing cold and very weak. I felt more normal by the end of the day. On the second and third day, I had swelling and tenderness at the injection site." Nonenone . During the same period patient was treated with Birth control (depo provera). Patient recovered.

HPV (GARDASIL) Side Effects Report #339760
HPV (GARDASIL) vaccine side effect was reported on 01/15/2009. Female patient, 18.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Pallor, "Pt given GARDASIL vaccine about 15 minutes later. Pt had light headiness and dizzy, pale and nausea." . Patient recovered.

HPV (GARDASIL) Side Effects Report #340451
HPV (GARDASIL) vaccine side effect was reported on 02/13/2009. Female patient, child 12.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Pallor, "Information has been received from a consumer concerning her daughter who on 18-Apr-2008 was vaccinated with the first 0.5ml dose of GARDASIL. After getting the first dose the patient experienced joint pain in back, hip and knees. On 16-Jul-2008 received the second dose of HPV vaccine and experienced fainting, dizziness, headache, trouble comprehending in school and joint pains. At the time of reporting the mother's patient stated that daughter still had headaches and dizziness. The patient sought unspecified medical attention. Additional information has been requested. 6/19/09 Medical records received DOS 4/4/08 to 5/08/09. Assessment: Insomnia, weight loss, otitis externa acute, depression with anxiety Patient became pale and c/o blurred vision, dizziness. Difficulty walking, lightheaded. Later otalgia, URI. Aching joints - hip, back, knee. Headache, abdominal pain, anxiety. Coughing, nose congestion with headaches, postnasal drip, sore throat. acute sinusitis, dyspnea. Hyperactivity. PTSD. ICD-9 Codes: 780.52, 783.21, 380.10, 300.4, 461.9 786.2 786.09, 784.0 789.07, 300.00, 995.20, 780.4, 388.70, V65.40, 465.9, V04.89" Unknown. 6/19/09 Medical records received DOS 4/4/08 to 5/08/09. Erythromycin allergy.Unknown. 6/19/09 Medical records received DOS 4/4/08 to 5/08/09. LABS and Diagnostics: Spirometry. CBC - WNL. TSH 1.220 ulU/ml. . During the same period patient was treated with Unknown. Patient recovered.

HPV (GARDASIL) Side Effects Report #340631
HPV (GARDASIL) vaccine side effect was reported on 02/13/2009. Female patient was vaccinated with HPV (GARDASIL). Patient symptoms: Pallor, "Information has been received from a female patient, with no known drug reactions/allergies and no pertinent medical history, who was vaccinated with three doses of GARDASIL. There was no concomitant medication. The consumer stated she is seeing a new doctor and the doctor provided her with a fourth dose of GARDASIL. She also mentioned she vomited and turned pale white taking the doses of GARDASIL. No further information is available." NoneNone . During the same period patient was treated with None. Patient recovered.

HPV (GARDASIL) Side Effects Report #340020
HPV (GARDASIL) vaccine side effect was reported on 01/28/2009. Female patient, 17.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Pallor, "Gave vaccines, pt. was nervous, I left the room so pt. could get dressed. MOP said pt. got up to change and pt. fell back. Pt. was pale. We laid her down in the bed, gave her water and checked vitals. Was checked by physician after and was cleared to go home. Ok." NoneNone . Patient recovered.

HPV (GARDASIL) Side Effects Report #340357
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: Pallor, "Patient received her 1st GARDASIL shot on 1-16-09. She received no other shots and was on no medication. On 1-20-09, patient woke up with flu-like symptoms fever, upper respiratory congestion, body aches, and weakness. On 1-22-09, patient was treated at urgent care for her flu-like symptoms and bronchitis. She was given a 1st dose of Azithromycin, PREDNISONE and MUCINEX mid-morning. After sleeping for 2 1/2-3hours, patient got up, sat down to eat felt ill, got up, and passed out, hitting her two front teeth and severing them. She went by ambulance to hospital ER, although she regained consciousness right away, her skin was a strange white color and her pupils were dilated. She has had no other problems since her ER treatment, but her two front teeth had to be replaced with crowns. 3/16/09-ED records received for DOS 1/22/08-presented with C/O lightheadness, syncope, nausea, felt faint, brief loss of consciousness. Abrasions on inner lips, oral laceration, suturing required. Dental injury. Impression: syncope." Noneallergic to Amoxicillin"EKG, normal; Chest X-ray, showed bronchitis 3/16/09-records received-WBC 3.2, Hgb 14.9, neutrophils elevated 77.8, lymphocytes decreased 15.4, glucose 110. Chest x-ray normal." . During the same period patient was treated with not at time of vaccination. Patient recovered.

HPV (GARDASIL) Side Effects Report #340421
HPV (GARDASIL) vaccine side effect was reported on 02/23/2009. Female patient, 14.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Pallor, "Client became pale and complained of being nauseated and light-headed. RN assisted client in putting her in a supine position with legs elevated. This releaved the light-headedness but client continued to be pale and nauseated. These symptoms began immediately after injection and continued for 20 minutes at which time the client stated she felt okay, skin color had returned to normal and she was sent home with her mother." noPCN . During the same period patient was treated with none. Patient recovered.

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

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

HPV (GARDASIL) Side Effects Report #341052
HPV (GARDASIL) vaccine side effect was reported on 02/25/2009. Female patient, 13.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Pallor, "4-21 - 4-22-08 was in hospital for syncopal episode. She had normal EEG recording. Was referred for evaluation of a 2 months Hx of spells. First in 2/2/08 - Felt chills, hands & face turned white with corresponding perioral cyanosis. Tachycardic with sweaty palms. Episode free for 3 mo. 4/14/09-records received for DOS 4/21/08-referred for evaluation of 2 month history of spells beginning 2/08, C/O feeling chilled to face and hands turned white with corresponding perioral cyanosis, tachycardic, sweaty palms. Seen in ED with normal EKG, CBC, chemistires. Out of country travel and upon return increase in spells. Syncope." NoneSyncopal EpisodesChild has exercise induced Asthma- Symptoms above noted prior to HPV inj 4/14/09-records received-Normal cranial CT. Video EEG no abnormalities and no chanages with symptoms more likely vasomotor etiology as their cause. 24 hour urine for . Patient was hospitalized Patient recovered.

HPV (GARDASIL) Side Effects Report #341119
HPV (GARDASIL) vaccine side effect was reported on 03/03/2009. Female patient, 14.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Pallor, "Child rcvd ADACEL, MENACTRA, FLUZONE, Hep A, VARIVAX, and GARDASIL - just after receiving GARDASIL she stiffened up and eyes rolled back, turned pale, teeth clenched according to mom; BP - 119/79 - HR -~70/min- area no urticaria, lungs CTA, No angioedema- episode lasted approx 5 mins - received O2 via IVC (2 liters)." NoneNone . Patient recovered.

HPV (GARDASIL) Side Effects Report #341342
HPV (GARDASIL) vaccine side effect was reported on 02/27/2009. Female patient, child 11.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Pallor, "After 5th injection, pt. felt nauseated then proceeded to faint. Recovered after anonic inhalent used. Again c/o nausea, sleepiness. Was very pale and sleepy. Was able to walk to car approx 45 hours later." NoneNoneNone . During the same period patient was treated with None. Patient recovered.

HPV (GARDASIL) Side Effects Report #341343
HPV (GARDASIL) vaccine side effect was reported on 02/27/2009. Female patient, 13.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Pallor, "Immediately after 4th injection (HPV) Pt had stiffening of body, gluteral oral sound, fixed stare, then fainted. Vomited after recovery from faint. Was pale with faint pulse. After resting she recovered without incident." None"Allergic :PCN ~hives~ per mom"None . During the same period patient was treated with None. Patient recovered.

HPV (GARDASIL) Side Effects Report #341458
HPV (GARDASIL) vaccine side effect was reported on 03/10/2009. Female patient, 14.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Pallor, "PATIENT REFERS DIZZINESS, PERSPIRATION AND PALENESS.LASTED FOR 20 MINUTES. RECOVERED AFTER LAYING DOWN." NONENONE . During the same period patient was treated with NONE. Patient recovered.

HPV (GARDASIL) Side Effects Report #341658
HPV (GARDASIL) vaccine side effect was reported on 03/10/2009. Female patient, 20.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Pallor, "Within Minutes of receiving HPV vaccines, became light headed pale, nauseated, weak, vomited, had muscle weakness until next day. Mother refused to let patient have 3rd dose but never informed us of above until today, 3-10-09." NoneNone . Patient recovered.

HPV (GARDASIL) Side Effects Report #342201
HPV (GARDASIL) vaccine side effect was reported on 03/13/2009. Female patient, 15.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Pallor, "Information has been received from a registered nurse concerning a 14 year old female student with no known medical history and drug allergies, who on 14-FEB-2009 at 10:00 was vaccinated with a second dose of GARDASIL (lot # 661766/0652X), intramuscularly into the right deltoid. Concomitant suspect therapy included hepatitis A vaccine (MSD) (lot # 658174/1297X), intramuscularly into the left deltoid on 14-FEB-2009. On 14-FEB-2009 at 10:00 after receiving the second dose of GARDASIL the patient became pale, and fainted for approximately 1-2 minutes. Blood pressure was 120/10. It was also reported that the patient was complaining of numbness in right arm. The patient also experienced fainting after the first dose of GARDASIL when she was 14 years old. No laboratories studies performed. No further information is available." NoneNone . During the same period patient was treated with Unknown. Patient recovered.

HPV (GARDASIL) Side Effects Report #342238
HPV (GARDASIL) vaccine side effect was reported on 03/13/2009. Female patient, 15.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Pallor, "Information has been received from a registered nurse concerning a 15 year old female patient with no pertinent medical history and no known drug allergies/drug reactions who on 17-FEB-2009 was vaccinated with the second dose of GARDASIL (Lot # 659655/0940X) intramuscularly into the left deltoid at 12:45. Secondary suspect therapy on 17-FEB-2009 included a second dose of hepatitis A virus vaccine inactivated (MSD) (Lot # 658174/1297X) intramuscularly into the right deltoid. It was reported that on 17-FEB-2009 at 13:00, the patient became pale and felt nauseated after receiving the second dose of GARDASIL for approximately 10 minutes. There were no laboratory tests performed. Additional information has been requested." NoneNone . During the same period patient was treated with None. Patient recovered.

HPV (GARDASIL) Side Effects Report #342379
HPV (GARDASIL) vaccine side effect was reported on 03/13/2009. Female patient, 15.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Pallor, "Information has been received from a nurse practitioner concerning a 15 year old female who was vaccinated with the second dose of GARDASIL (lot # not reported) 0.5ml intramuscularly. Concomitant therapy included SUDAFED taken that morning. On 18-FEB-2009 ~the patient got very pale, curled up into the fetal position, and fainted~. Later on the patient was conscious and ~lying on sofa~ In the doctor's office. Patient sought unspecified medical attention. No lab diagnostics studies performed. Events improved after stopping therapy and reappeared after reintroduction. Additional information has been requested." UnknownNone . During the same period patient was treated with SUDAFED. Patient recovered.

HPV (GARDASIL) Side Effects Report #342060
HPV (GARDASIL) vaccine side effect was reported on 02/11/2009. Female patient, 24.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Pallor, "Pt had a c/o feeling as though she were going to pass out as she was checking out with secretaries. Secretary called M.A. and they assisted Pt to sitting in chair. MA got me to check Pt. Pt stated she felt like she was going to pass out, had blurry vision, tingling to hands and ringing in her ears. BP 92/54, R 18, P 78 weak, Pt stated she felt clammy, Pt too weak to transfer to w/c -> exam room at that time. Color slightly pale. BP 96/60, P62. After sitting up 10~ BP 98/62, P62, R-15 10~ later BP 98/62 P60. Standing BP98/60 P60 R-15 color improved, clammy feeling gone, Pt stated she thinks it was made worse by becoming frightened by Sx's. Pt released to home once WNL- baseline." . Patient recovered.

HPV (GARDASIL) Side Effects Report #342560
HPV (GARDASIL) vaccine side effect was reported on 03/13/2009. Female patient, child 9.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Pallor, "After receiving MENACTRA, in process of receiving GARDASIL, child became extremely pale and experienced LOC x about 15 seconds, slumping into chair. Head protected thru out. Given liquids and observed for 1/2 hour. Mentating well, no dizziness when ambulating when discharged." nonenone . Patient recovered.

HPV (GARDASIL) Side Effects Report #342562
HPV (GARDASIL) vaccine side effect was reported on 03/19/2009. Female patient, 15.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Pallor, "(D:) BP 102/60; P 60 - R-12;- Pt feel lightheaded, skin tone change to pale. Saw spots, alteration in hearing (A:) Pt given Kool Aid to drink Patient lay on back on exam table, syst symptoms resolved, BP 102/60 P. 60 (R:) Symptoms resolved." NoneHx of lightheadness with BM last summer; hx of of hives . During the same period patient was treated with BENADRYL night before; vitamins. Patient recovered.

HPV (GARDASIL) Side Effects Report #342569
HPV (GARDASIL) vaccine side effect was reported on 03/17/2009. Female patient, 13.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Pallor, "GARDASIL dose #3 1/27/09 2/17/09 - Dysuria with Lower Abdominal Pain UA - Large Blood, small leuks, Prot > 300 mg/DL cx-neg symptoms lasted 1 week - Repeat urine x 2 - normal. 4/3/09 Received vac records & PCP medical records for 2/17-2/26/2009. FINAL DX: UTI, dysuria Records reveal on 2/17/09 patient experienced pain w/urination, grequency & urgency x 1 day. Had just completed menses. Tx w/oral antibiotics. RTC 2/26 & had felt unwell since 1/27. Had eye infection 2/4, possible UTI 2/11 & now UTI w/abdominal pain & dysuria. Exam revealed erythematous blanching rash thought to be drug vs vaccine reaction. Antibiotic d/c. No further records available." LABS: Urine c/s of 2/17 no growth. UA 2/24 WNL. . Patient recovered.

HPV (GARDASIL) Side Effects Report #342701
HPV (GARDASIL) vaccine side effect was reported on 03/25/2009. Female patient, 16.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Pallor, "Information has been received from a physician assistant concerning a 16 year old female with no allergies who on 12-NOV-2008 was vaccinated with the first dose of GARDASIL. On 12-MAR-2009 the patient was vaccinated with the second dose of GARDASIL . Concomitant therapy included MENACTRA on 12-MAR-2009 into opposite arm, LEXAPRO and RECLIPSEN. On 13-MAR-2009, almost exactly 24 hours after administration, she experienced blacking out, legs feeling like ~dead weight~, her lips turned blue, she had an ashen color to her skin, and she could not see or hear. She visited the physician assistant who admitted her to the hospital. She was given saline and was monitored on telemetry for cardiac function. She also had a CT scan (results not reported). She was discharged after 24 hours. Her blood pressure was 94/54. The patient recovered on an unspecified date. The patient's mother also told the physician assistant that after the first dose similar symptoms occurred but no black-outs. The symptoms occurred 24 hours after receiving first dose but the patient did not seek medical attention and had recovered. The events occurring 13-MAR-2009 were considered to be disabling. Additional information has been requested." Unknown"Blood pressure, 03/01?/09, 94/54" . During the same period patient was treated with RECLIPSEN; LEXAPRO. Patient was hospitalized Patient recovered.

HPV (GARDASIL) Side Effects Report #342775
HPV (GARDASIL) vaccine side effect was reported on 03/26/2009. Female patient, 19.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Pallor, "She came in for labs and for a Gardasil vaccination. She was vaccinated, and then while having labs drawn, she became lightheaded and fainted. Mother reports that she was having seizure like shaking while she was out. She did not hit her head, it was a very short period before she responded, was slightly pale, but otherwise herself. No postictal changes. BP low in the 70's initially. She had some ginger ale and cornbread and responded well. After about half an hour she had an excellent BP of 110/70. BP remained stable free standing and walking out." Excessive daytime sleepinessnone . During the same period patient was treated with "methylphenidate,". Patient recovered.

HPV (GARDASIL) Side Effects Report #343238
HPV (GARDASIL) vaccine side effect was reported on 04/01/2009. Female patient, 13.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Pallor, "several fevers a day, bad headaches with fever, sore throat, stopped up nose or runny, weak, upset stomach and vomiting, pale skin, cried because generally miserable most of the time.4/7/09-records received for DOS 3/24/09-office visit 3/24/09-C/O right ear pain increased temperature for about a month, headache, vomiting nausea all started after Gardasil injection. Now in clinic with C/O runny nose, sore throat, headache, right ear pain, sinus drainage for few days. One month ago received 2nd gardasil vaccine and started having fever. Assessment: right sided external otitis. Acute sinusitis. Office visit 4/1/09-No fever doing well, no hearing problem. Signs and symptoms improved. Assessment: right sided swimmer's ear improved. Acute sinusitis improved." nonenone . During the same period patient was treated with vitamins. Patient recovered.

HPV (GARDASIL) Side Effects Report #343332
HPV (GARDASIL) vaccine side effect was reported on 03/19/2009. Female patient, 14.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Pallor, "Patient turned pale a minute after receiving all 4 vaccines, then her lips turned blue 1/2 minute later, she had a seizure, with her eyes flipping upwards, then arms were shaking. The whole episode lasted 1-1/2 minutes. She had same reaction 3 yrs ago, when blood was taken for lab tests." EEG Pending . Patient recovered.

HPV (GARDASIL) Side Effects Report #343557
HPV (GARDASIL) vaccine side effect was reported on 03/23/2009. Female patient, 15.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Pallor, "Syncope 5 minutes after HPV (GARDASIL) vaccine lasted about 1 minute with L arm jerking X 3 sec pale looking referred to ER. BP 100/80, HR 78, RR 18, O2 sat 97%." "EKG-WNL, Accucheck 99. ER Labs: CBC Normal, BMP normal except glucose 192" . Patient recovered.

HPV (GARDASIL) Side Effects Report #343651
HPV (GARDASIL) vaccine side effect was reported on 03/31/2009. Female patient, child 11.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Pallor, "Immediately following injection pt. became stiff, eyes rolled in back of head, bluish + orange around mouth, + pt. was having jerking motions of entire body. Pt. lowered to floor protected from self injury. 15 seconds elapsed from beginning to end of episode. Pt sat up A & D x 4, skin pale W/D. RC 20 O2 Sat 97% P: 76 B/P 98/56." Hay FeverBlood Sugar 108/Pt. to local ER for precautionary check. . During the same period patient was treated with Claritin. Patient recovered.

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

HPV (GARDASIL) Side Effects Report #343934
HPV (GARDASIL) vaccine side effect was reported on 04/10/2009. Female patient, 16.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Pallor, "After administration of all 4 vaccines, upon departure and standing, client reported feeling dizzy. Assisted client back to chair. Client fainted. Incoherent or unconscious for approximately 30 seconds. Client then nauseated and vomited clear fluid (mucus); pale. BP assessed and cool rag applied to forehead. Given water to drink. Remained in clinic 20-25 minutes. BP assessed and monitored. Stable at departure. Voiced no complaints at departure." noneBorn with heart murmurnone . During the same period patient was treated with none. Patient recovered.

HPV (GARDASIL) Side Effects Report #343977
HPV (GARDASIL) vaccine side effect was reported on 04/09/2009. Female patient, 15.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Pallor, "pass out after the shots, became pale around 5 sec no treatment needed." NoneNoneNone . During the same period patient was treated with None. Patient recovered.

HPV (GARDASIL) Side Effects Report #344181
HPV (GARDASIL) vaccine side effect was reported on 04/09/2009. Female patient, 18.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Pallor, "Patient left office after getting 4 vaccines. She was standing at window to make another appt. She asked for water then had a syncopal episode with ? of seizure activity. Very pale, weakness. Pt laid in waiting room. Pulse 56, BP 116/38. Was given apple juice & crackers. She had only eaten chocolate and water for breakfast. Moved to exam room. She was monitored for about 30 minutes. Rechecked by MD then left feeling fine." . During the same period patient was treated with "DEXAMETHASONE 4mg, PROMETHAZINE 23 mg". Patient recovered.

HPV (GARDASIL) Side Effects Report #344202
HPV (GARDASIL) vaccine side effect was reported on 04/03/2009. Female patient, 13.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Pallor, "Child became very pale, lightheaded and felt like she was going to faint. Child was also slightly diaphoretic. Had child lay down and gave water." NoneNone . Patient recovered.

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

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

HPV (GARDASIL) Side Effects Report #344583
HPV (GARDASIL) vaccine side effect was reported . Female patient, 15.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Pallor, "Immediately after vaccination, eyes rolled back, color became gray/green, leaned to left; mother supported her - nurse attempted to assist her to put head between knees and her back jerked and stiffened twice and her fingers were extended and hands shaky; she didn't recall what happened; described self as feeling ~daze-y~ Records received 05/01/2009 - DOS 04/21/2009. Seizure and R hand weakness post-adminstration of Gardasil and varicella. Review of systems unremarkable other than Hx of ADHD and depression. RX Prozac and Dexedrine. Headaches past 2 weeks. Discharge Dx: Seizure." NoneNone"mother took to urgent care and was referred to hospital ED; had MRI which was ~clear~; was told that it was seizure not due to immunization; referred for further neuro work up Records received 05/01/2009 - Labs, CT, MRI unremarkable." . During the same period patient was treated with Prozac 10; Dexedrine. 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: Pallor, "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 #344624
HPV (GARDASIL) vaccine side effect was reported on 04/22/2009. Female patient, 17.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Pallor, "Patient turned pale and diphoretic after administration of first Gardasil vaccine. Patient complained of feeling like she was going to pass out. Patient was told to lie down, feet were put up, patient was fanned. Recovered with in 1 to 2 minutes, did not pass out. Patient stated that she has passed out before with injections and when her umbilicus was pierced. Was very nervous prior to injection and started crying. Blood pressure after recovery was 90/68. Patient stated that she had not eaten yet today, time was around 1030am." napreviously has had syncopal episodes with injections and umbilicus piercing. . During the same period patient was treated with nuvaring. Patient recovered.

HPV (GARDASIL) Side Effects Report #344820
HPV (GARDASIL) vaccine side effect was reported on 04/22/2009. Female patient, child 11.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Pallor, "My daughter received her second GARDASIL vaccine and had 2 30-45 second seizure 15 minutes after the injection in the doctors office on the floor. She became pale, disoriented, her pupils were dilated and she kept saying she doesn't feel good thereafter the whole night long. She experienced a glaze for hour after, slow movement numbness to both legs and a headache and has twitching in her left arm still at the present time. I took her to the ER on my own judgement because the pediatrician said there was no need this was normal following this vaccine and she had bloodwork drawn and now has to have an EEG today. Something has to be said to this company. 5/5/09 Received medical records DOS 1/2/09 to 4/23/09. Includes imminzation records. FINAL DX: Seizures Two 'quick seizures' post vaccination. Also several episodes of eyes rolling, and twitching. 6/2/09 Received ER medical records for 4/21/2009. FINAL DX: seizure Records reveal patient experienced back to back seizures each lasting approx 15-20 secs w/no postictal period. Pt had dizziness s/p vaccination & then had seizure. No further seizure activity, no meds while in ER & d/c to home w/PCP f/u. Follow-up - Patient recovered. Patient's address updated." "She is learning disabled, she has apraxia, sensory integration dysfunction, and had a run of myoclonic seizures 5 years ago."A neurologist had received her results today I have to go see him in the office to find out where we go from here. We left the er after 5 hours and were exhausted so they said I didn't have to wait for the results she was negative the neur . Patient recovered.

HPV (GARDASIL) Side Effects Report #345052
HPV (GARDASIL) vaccine side effect was reported on 04/28/2009. Female patient, child 12.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Pallor, "Patient seated on a chair in exam room one with mother and younger brother present. Patient given HPV, Tdap, and Menactra vaccines at 4 pm by RNs. Patient chatted following the vaccine, said her arms really hurt, and was encouraged to move her arms using a small stacking toy, which she did. I discussed with patient's mom the vaccines and providing Tylenol/Advil to patient as needed. Toy suddenly fell onto the floor; patient's head leaned back against the wall, and patient's eyes rolled back into her head. Patient's mother shook her and spoke her name loudly several times with no response. Patient's color was becoming pale and slightly green. Patient's right hand briefly clenched into a fist and flexed at the wrist. I asked support staff to call 911 and ambulance was requested. Patient's mother and I lowered patient to floor and placed head onto floor and elevated legs onto chair. Patient opened eyes and eyes focused on us. Pulse and BP taken by RN and results were normal. RN made ready and available anaphylactic reaction medical protocol supplies. Patient covered with blanket and cool compress applied to forehead. Supervisor RN observed patient and noted that patient was now responding verbally and respirations were normal; ambulance request cancelled. Patient stated she was cold. Patient said she had not eaten much for lunch. Patient's coloring returned to normal. Patient's pulse continued to be normal. Patient assisted to a sitting position on the floor, given sweatshirt to wear, and drank 8 oz water. Patient assisted to standing position at 4:45 pm. Mother instructed to monitor patient's breathing and to take patient to ER immediately if breathing problems developed. Patient said she felt well enough to walk. Patient left to return home with mother and brother." NoneNone . Patient recovered.

HPV (GARDASIL) Side Effects Report #345165
HPV (GARDASIL) vaccine side effect was reported on 04/29/2009. Female patient, 14.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Pallor, "Client received Tdap without any symptoms of concern. Then, immediately after HPV vaccine was given, the client complained that her arm hurt. She turned her head away and when I checked on her(within seconds), her upper body stiffened and her head and arms started shaking. She was very pale. Shaking lasted 15-30 seconds, then her eyes were opened very wide and she seemed to be aware that something had just happened. She did not complain of dizziness, nausea, discomfort other than her right arm, headache or any other symptoms. Vitals lying down - 10:20 am: BP 118/70, pulse 88; 10:23 am BP 122/74, Pulse 64, Resp 14; 10:38 am BP 118/60, pulse 76; 10:46 am BP 108/68, resp. 20,pulse 80, temp 98.4. Vitals sitting upright - 10:53 am BP 110/70; pulse 76; 11:02 BP 118/40, Pulse 68, Resp. 16. Client was given Tylenol, peanut butter crackers and orange juice and reported feeling much better. Telephone messages left for parent." None knownAllergic to Pollens (hayfever-like symptoms) and Tomatoes eaten in large quantity cause rash & hives . During the same period patient was treated with Given Acetaminophen 650 mgs at 10:58 a.m.. Patient recovered.

HPV (GARDASIL) Side Effects Report #345308
HPV (GARDASIL) vaccine side effect was reported on 04/30/2009. Female patient, 16.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Pallor, "PATIENT WAS GIVEN ALL THREE VACCINES HEP A#1 (RIGHT ARM), MCV4 AND HPV#1 (LEFT ARM) IN THAT ORDER, WHEN I WAS APPLYING THE LAST BANDAID THE PT STATED SHE FELT DIZZY AND SLUMPED TO HER RIGHT SIDE ON THE EXAM TABLE THIS WAS 3:55 PM. I PULLED HER TOWARDS ME SO SHE WOULD BE FLAT ON HER BACK AND WHEN I DID SHE THEN LOOKED AT ME AND SAID DID I JUST PASS OUT. THIS WAS BRIEF MAYBE 5-10 SECONDS SHE HAD SOME PALLOR AFTER FAINTING SHE WAS GIVEN A COOL WASH CLOTH FOR HER FOREHEAD AND ADVISED TO STAY LAYING FOR A FEW MINUTES DR. WAS NOTIFIED AND BP WAS TAKEN AND @ 3:57 BP WAS 98/60. PATIENT WAS ALERT AND ORIENTED X3 AND JOKING AND REMEMBERS EVERYTHING BEFORE AND AFTER EVENT. BP PRIOR TO FAINTING WHICH WAS TAKEN AT ABOUT 3:45 WAS 100/50. PT WAS MONITORED APPEARED ASYMPTOMATIC COLOR CAME BACK AND LAST BP @ 4:22 WAS 100/60 PT WAS THEN ALLOWED TO LEAVE @ 4:30. SHE WAS ADVISED TO COME BACK TOMM (4/30/09) AND FOLLOW UP WITH DR. APPOINTMENT WAS MADE." NONEALLERGIC RHINNITIS (SEASONAL ALLERGIES) MOM STATED MAY BE ALLERGIC TO PENICILLINNONE . During the same period patient was treated with NONE. Patient recovered.

HPV (GARDASIL) Side Effects Report #345686
HPV (GARDASIL) vaccine side effect was reported on 04/30/2009. Female patient, 14.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Pallor, "Patient fainted, difficult to arouse (12 sec) utilized ammonia to arouse. Patient stopped breathing during fainting spell. Patient cold, pale and clammy fingertips blue with c/o tingling in fingertips then legs. Blood pressure 92/58, pulse 60. RR16. 911 called. Patient transported to nearest ER." NoneNone Known . During the same period patient was treated with None. Patient recovered.

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

HPV (GARDASIL) Side Effects Report #345789
HPV (GARDASIL) vaccine side effect was reported on 05/05/2009. Female patient, 13.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Pallor, "Information has been received from a nurse concerning a her great-niece 13 year old female with no known allergies or medical history reported, who on 28-APR-2009 was vaccinated with her first dose of GARDASIL (dose, route of administration and lot number not reported). There was no concomitant medication. The nurse reported, the patient two seizures soon after receiving her first dose of the vaccine. The first seizure was described as violent jerking, stiffness, frothing at the mouth, tongue deviated to the right and eyes rolled back lasting five minutes. The patient experienced a second seizure within the hour as she was being escorted from the office. The patient was transported home by her mother and was recovering, although still ~weak and pale~. The patient sought unspecified medical attention. Upon internal review, seizure was determined to be an other important medical event. Additional information has been requested." NoneNone . During the same period patient was treated with None. Patient recovered.

HPV (GARDASIL) Side Effects Report #346438
HPV (GARDASIL) vaccine side effect was reported on 05/15/2009. Female patient, 13.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Pallor, "This case was reported by a healthcare professional and described the occurrence of fainting in a 13-year-old female subject who was vaccinated with HAVRIX (GlaxoSmithKline), MENACTRA (non-gsk) (Sanofi Pasteur), GARDASIL (non-gsk) (Merck) and VARIVAX (non-gsk) (Merck). On 12 May 2009 at 15:30 the subject received 1st dose of HAVRIX (unknown route, left arm). On 12 May 2009 the subject also received 1st dose of MENACTRA (Non-GSK) (details unknown), 1st dose of GARDASIL (Non-GSK) (details unknown), and 2nd dose of VARIVAX (Non-GSK) (details unknown). On 12 May 2009, 52 minutes after vaccination with HAVRIX, and less than one day after vaccination with GARDASIL (Non-GSK), MENACTRA (Non-GSK) and VARIVAX (Non-GSK), the subject experienced fainting, became pale and shaky, and fell. She had to sit for 10 minutes with her head between her legs and was given an energy bar and an unspecified drink. This case was assessed as medically serious by GSK. At the time of reporting the events were resolved." UnknownUNK . Patient recovered.

HPV (GARDASIL) Side Effects Report #346443
HPV (GARDASIL) vaccine side effect was reported on 05/15/2009. Female patient, 13.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Pallor, "1:35 Pt complaints of dizziness, Pt put head on desk. At 1:38 pt vomited small amt, color pale, clammy, alert oriented B/P 100/72 - Pt states she is hungry. Juice + cereal offered & taken is problem. Pt states she is good - color normal. B/P 98/64 - Seen by MD & left with no acute distress." None . Patient recovered.

HPV (GARDASIL) Side Effects Report #346672
HPV (GARDASIL) vaccine side effect was reported on 05/14/2009. Female patient, 23.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Pallor, "Information has been received from a nurse concerning a 23 year old female with a penicillin allergy who on 02-APR-2009 was vaccinated with GARDASIL, lot number 661846/1312X. Concomitant therapy included XANAX, LAMICTAL and GEODON. On 01-APR-2009, the nurse reported the patient's blood pressure dropped and her color became pale after a dose of GARDASIL was given. The patient complained of ~feeling faint but did not actually faint~. The patient sought medical attention she spoke with the nurse. The patient was recovered on 2-APR-2009. No further information was reported. Additional information has been requested." Penicillin allergy . During the same period patient was treated with XANAX; LAMICTAL; GEODON. Patient recovered.

HPV (GARDASIL) Side Effects Report #346869
HPV (GARDASIL) vaccine side effect was reported on 05/14/2009. Female patient was vaccinated with HPV (GARDASIL). Patient symptoms: Pallor, "Information has been received from a healthcare worker concerning a 12 or 13 year old female patient with no relative medical history, drug reactions or allergies who in January 2009, was vaccinated IM with her second dose of 0.5 ml GARDASIL (lot number, site and route not reported). The date of the first dose was not available. There was no concomitant medication. The patient became pale and dizzy after the second dose. On an unspecified date, the patient recovered from pale and dizzy. The patient had sought medical attention in physician's office. Follow-up information was received from a certified medical assistant who reported that he didn't know the patient's name or date of birth or the date that the patient received the first dose. On 22-JAN-2009 the patient was given the second dose of GARDASIL (lot number 661764/0650X). It was reported that no other vaccines were given to the patient that day. On 22-JAN-2009, after the patient was given the vaccine, she became pale and dizzy with no syncope. At this report time, the patient recovered. No further information was reported." NoneNone . During the same period patient was treated with None. Patient recovered.

HPV (GARDASIL) Side Effects Report #346632
HPV (GARDASIL) vaccine side effect was reported on 05/18/2009. Female patient, child 9.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Pallor, "- Pain & bruised at injection site - high fever - Paleness, Weak, dizzy - Sore throat, ear ache, sore eyes - chills 3 days MOTRIN & TYLENOT given" NoneNone . During the same period patient was treated with None. Patient recovered.

HPV (GARDASIL) Side Effects Report #346765
HPV (GARDASIL) vaccine side effect was reported on 05/19/2009. Female patient, 18.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Pallor, "Pt felt faint after receiving ADACEL, MENACTRA and GARDASIL. She then became opisthotonic, began salivating, eyes rolled back. Episode lasted about 15 sec. Pt c/o not being able to see. She recovered completely. Vision normalized. 11/02/02 Medical record received for DOS 06/15/09. Neuro visit. Patient passed out s/p vaccines. Brief dizziness before. Diaphoretic after. Pale. No postictal confusion. Nausea/dizziness x1hr after. One or two arm/leg jerks in phase. No rhythmic jerking. No pain. PE wnl. Neuro exam wnl. EEG abnormal but not relevant. Syncopal episode. 11/4/09 Medical records received for date 6/15/09. Neuro consult. DX: syncope. Presenting SX: episodes of passing out following vax, menactra, hepatitis, gardasil. Pt recalls brief dizziness prior to passing out, after passing out pt. states (+)sweating, (+)pale, (+)nausea and dizziness after episode. Parent witnessed 1 or 2 jerks of arms and legs in phase. Assessment: PE WNL, EEG abnormal, showed some sharp waves in the left temporal region." Pt to have EEG . During the same period patient was treated with None. Patient recovered.

HPV (GARDASIL) Side Effects Report #346846
HPV (GARDASIL) vaccine side effect was reported on 05/19/2009. Female patient, 16.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Pallor, "The patient turned pale, felt tingling all over, pupil dilated and was blurring over. PR = 80 / mier Bp = 90/60." . Patient recovered.

HPV (GARDASIL) Side Effects Report #346999
HPV (GARDASIL) vaccine side effect was reported on 05/22/2009. Female patient, 15.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Pallor, "Immediately after administering the vaccine, the patient experienced near-syncope: pallor, diaphoresis, hypotension and bradycardia. This lasted over 1.5 hours until she was transported by EMS to the ED. Her BP baseline was 125/75 with pulse 108, but during the event BP was 80's/50's with pulse in the 50's. Standing caused dropping of BP and pulse and diaphoresis and near-syncope. 7/7/09 ER records received DOS 5/22/09. Assessment: Vasovagal Syncope. Patient instantly developed lightheadedness and had syncopal episode. Presented with low blood pressure and pulse." no acute illness. 7/7/09 ER records received DOS 5/22/09. LABS and DIAGNOSTICS: None."allergy to fruit; attention-deficit disorder; Kawasaki disease as a child that led to coronary aneurysm that completely resolved per cardiologist. 7/7/09 ER records received DOS 5/22/09. ADD, T&A." . During the same period patient was treated with Vyvanse - not taken on day of vaccine. Patient recovered.

HPV (GARDASIL) Side Effects Report #348485
HPV (GARDASIL) vaccine side effect was reported on 06/04/2009. Female patient, 13.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Pallor, "Approx 5 min after receiving immz, pt appeared to have a seizure; loss of consciousness <45 seconds, jerky movements, urinated on self. Ammonia inhalant used, pt. conscious, pale color, O2 given-approx after 1 minute pt AOX3. However, approx in the next 3 minutes pt again appears to have another seizure in the same manner as above, lasting approx <45 seconds. 911 called, pt stabilized and transported to ER. I spoke with the parent the next day and she advises that they discharged her and diagnosed her as having a seizure and the follow up; the parent advised she will follow up. 6/10/09 Received ER medical records of 6/1/2009. FINAL DX: acute syncopal episode, mild volume depletion Records reveal patient experienced altered mental status x 2 episodes, dizziness, hypotonia & orthostatic collapse w/fall, tonic-clonic seizure-like activity, urinary incontinence. Was hypotensive in ER. Tx w/IVF, improved & d/c to home w/PCP f/u. Returned to ER on 6/2/09. FINAL DX: Fever, viral syndrome. Experienced low-grade fever. Tx w/IV antibiotic. LP performed." None known of.None known of. Parent advises no previous adverse signs and symptoms with immunizations."Medical Center did lab work and CT scan, per parent unknown results. Medical records state LABS: CT head WNL.CBC, BMP & CSF tests WNL. CSF c/s neg." . During the same period patient was treated with unknown. Patient recovered.

HPV (GARDASIL) Side Effects Report #348550
HPV (GARDASIL) vaccine side effect was reported on 06/02/2009. Female patient, child 11.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Pallor, "Approx 5 minutes after injection Pt became rigid all over, very stiff, and fell down to table. After several minutes then began to arise but was very groggy, clammy, pale and c/o ringing ears and could not hear. BP decrease 80/50.Watched and monitored over 30 minutes which at which time was lunching and felt better and released to home with mother. 12:45PM called Pt to check on her and mom states was doing very well." NoneNoneNone . Patient recovered.

HPV (GARDASIL) Side Effects Report #348737
HPV (GARDASIL) vaccine side effect was reported on 06/04/2009. Female patient, 26.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Pallor, "GARDASIL vaccine - neuritis (LUE) - thoracic outlet syndrome - no strength (L) arm/(R) arm (decrease strength)- decrease vasc (L) arm (with elevation - color pale/cool) (L) - left more than right. Hasn't changed or lessened for 2 years. 6/25/09 PCP records received DOS 5/4/09 to 6/15/09. Assessment: Arm numbness and pain post HPV vaccine. Patient states ~feels like the blood is not in her arms.~ Pulses in arms disappear when in a military position. Intermittant RLQ pain, L flank pain, back pain, R rhomboid muscle region discomfort, keloid R ankle, Venous insufficiency with varicose veins L lower extremity. Retroverted uterus, thickening of endometrium, ovarian cysts. Congenital L renal hypoplasia, compensatory hypertrophy R kidney. Gardasil #1 (Lot# 1486U) LA - 4/16/08. Gardasil #2 (Lot# 1486U) RA - 6/16/08." NoneNKDA; No med conditionsNone. 6/25/09 PCP records received DOS 5/4/09 to 6/15/09. LABS and DIAGNOSTICS: Ultrasound Pelvis - Abnormal. Ultrasound Abdomen - Abnormal. Chest X-Ray - No abnormalities. CTA of abdominal aorta and renal ateries with CT of abdomen and pel . During the same period patient was treated with None. Patient recovered.

HPV (GARDASIL) Side Effects Report #348790
HPV (GARDASIL) vaccine side effect was reported on 06/08/2009. Female patient, 16.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Pallor, "Pt. stated stomach felt queasy; sat down; says her vision was fuzzy; became pale; fainted; assisted to a lying position et fanned; regained consciousness within 1-2 sec.; stated ~felt like a dream~; sat up after 5 min. felt faint again; lost color again; laid back down; fanned; talked to staff and family; sat up again after 5min; ate snack good color; strong pulse; stood up - no problems; left." NoneNone . During the same period patient was treated with None. Patient recovered.

HPV (GARDASIL) Side Effects Report #348964
HPV (GARDASIL) vaccine side effect was reported on 06/11/2009. Female patient, 15.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Pallor, "Immediately after vaccine was given, the patient developed pallor and was dizzy." none known . Patient recovered.

HPV (GARDASIL) Side Effects Report #349191
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: Pallor, "Information has been received from a physician concerning a 15 year old female with PENICILLIN allergy and no pertinent medical history who was vaccinated with three doses of GARDASIL (lot # 659435/1265U, exp: 16-JUL-2010) 0.5 ml, intramuscular administration. She received the first dose on 19-MAY-2008, the second dose on 09-JUL-2008, and the third dose on 05-NOV-2008. Concomitant therapy on 19-MAY-2008 included doses of ADACEL (lot # not reported), and MENACTRA (lot # not reported), other concomitant therapy included FLONASE. Two or three months after the third dose of GARDASIL (lot # 659435/1265U), exp: 16-JUL-2010, in January or February 2009, the patient experienced redness and tingling to the distal aspect of the feet when standing upright and redness in the left calf after walking, ~such as in a mall~. The patient was seen in the office on 24-APR-2009 and blood work was obtained. Results of labs were as follows: antinuclear antibody (ANA) and rheumatoid factor (RF) were negative. Urine drug screen (at the mom's request because she thought her daughter was doing drug) was negative. Sedimentation rate (sed rate) was 4, hemoglobin was 12.9, white blood cell count was 6.5, and platelet count was normal. The patient was seen again on 04-MAY-2009, and there was significant erythema, pinkness, and warmth distally when the left leg was in a dependent position. The patient was referred to a vascular surgeon for further evaluation. At the time of reporting the patient's symptoms persisted. Additional information has been requested. 7/13/09 Medical records received DOS 4/24/09 to 5/4/09. Assessment: Pain in limb/Bilateral, unchanged. Patient presents with feet that turn red and skin stings when she stands for over 10 minutes. Pain in calf when she walks in the mall. Pins and needles sensation in feet. Feet are erythematous, blanches, great toes are warmer than rest of foot. Surgical referral suggested." Penicillin allergy7/13/09 Medical records received DOS 4/24/09 to 5/4/09. Penicillin allergy.Serum ANA 04/24/09 - negative; serum rheumatoid factor 04/24/09 - negative; urine drug screen 04/24/09 - negative; erythrocyte 04/24/09 4 - ; hemoglobin 04/24/09 12.9 - ; WBC count 04/24/09 6.5 - ; platelet count 04/24/09 - normal . During the same period patient was treated with FLONASE. Patient recovered.

HPV (GARDASIL) Side Effects Report #349323
HPV (GARDASIL) vaccine side effect was reported on 06/12/2009. Female patient, 16.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Pallor, "Information has been received from a physician Assistant and a Licensed Practical Nurse concerning a 16 and half years old female with familial risk factor who was vaccinated with three doses of GARDASIL ON 11-APR-2008, 13-JUN-2008 and 9-JAN-2009. Concomitant therapy included ALASE. The patient had no known drug allergies. On 25-AUG-2008 the patient experienced syncope and was sent to the emergency room (hospital name unknown). At the patient's office visit on 16-JAN-2009 it was reported that on 14-JAN-2009 the patient felt dizzy while driving (with a sibling as passenger), she pulled over then blacked out. On 16-JAN-2009 the patient had CT scan and EEG done and CT scan results were normal but EEG results were abnormal and it showed that she underlying predisposition for seizures. It was known that the patient had a ~family history of seizure disorder~. The patient was referred to Neurologist. The neurologist did not wish to provide any information on this case. A nurse at the county health department reported that the patient was not in their system. Therefore, lot #'s could not be provided. The patient's experience was not felt to be life-threatening. The patient's status was listed as recovering. The health care professionals contacted during telephone follow up could not supply the following information: lot numbers and hospital name (ER visited 25-AUG-2008). No further information is available at this time. 6/23/09 Neurological consult received DOS 4/02/09. Assessment: seizures, syncope. Patient c/o of an episode consisting of stomach hurting, sweating, feeling hot. Pale and unable to recall subsequent events. Lost conciousness. Also slumped over once while driving and had car wreck. Lightheadedness. Episodes of staring. Myoclonic jerks while sleeping. Sleeps a lot, recent weight gain, distractible. ICD-9 Codes: Spells 780.39, Abnormal EEG 794.02, Syncope 780.2, R/O Epilepsy 345.90 6/29/09 Medical records received DOS 8/07/08 to 4/08/09 Assessment: Cephalgia and Syncope. Patient presents with abd" Familial risk factor; Contraception6/23/09 Medical records received PMH: Tonsillectomy and adenoidectomy."computed axial, 01/16/09 - normal; electroencephalography, 01/16/09 - abnormal; underlying predisposition for seizure 6/23/09 Medical records received LABS and DIAGNOSTICS: EEG - single generalized burst of spike wave activity. Plts 457" . During the same period patient was treated with ALASE. Patient recovered.

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

HPV (GARDASIL) Side Effects Report #349682
HPV (GARDASIL) vaccine side effect was reported on 06/22/2009. Female patient, 16.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Pallor, child received HPV and had fingerstick for hemoglobin. left exam room and was sitting alone in conference room began to feel light headed and was heard to hit her head on desk. She had not eaten breakfast. Child was kept on the floor and given oxygen and felt better. She again sat up and shortly afterwards became pale and light headed again and was laid down on the floor. She was sent to the ER for further evaluation and management since head trauma was unwitnessed nonenone . During the same period patient was treated with none. Patient recovered.

HPV (GARDASIL) Side Effects Report #350006
HPV (GARDASIL) vaccine side effect was reported on 06/24/2009. Female patient, 14.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Pallor, "Client became pale and lightheaded at clinic, but recovered on own. Mother called in this AM to report taking client to ER on 06/19/09 PM near midnight due to c/o dizzy, room spinning when eyes closed, afraid to go to sleep, thinking she was going to pass out; says O2 was a little low, unsure how low, blood sugar was fine, vitals were ok, never seen by MD x 7 hours, left. Reports similar episode last PM, but not taken back to ER, plans to schedule appt with PHP today. RN encouraged f/u with PHP, discussed continued symptoms with District Immunization Coordinator." None.None.N/A. . During the same period patient was treated with None.. Patient recovered.

HPV (GARDASIL) Side Effects Report #350112
HPV (GARDASIL) vaccine side effect was reported on 06/22/2009. Female patient, 14.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Pallor, "45 to 60 seconds after injection, patient became pale, diaphoretic and fainted. LOC about 10-15 seconds. Responded to stimuli and had no other problems." nonenone . Patient recovered.

HPV (GARDASIL) Side Effects Report #350235
HPV (GARDASIL) vaccine side effect was reported on 06/25/2009. Female patient, 15.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Pallor, "Information has been received from a Physician Assistant (P.A) concerning a 15 year old female patient who on 13-JUN-2009 was vaccinated with the first dose of GARDASIL (Lot # not reported). It was reported that the patient fainted right after receiving the first dose of GARDASIL on 13-JUN-2009. It was reported that the patient was was brought to the emergency room and stayed there for a few hours. The patient was not admitted to the hospital. The patient sought medical attention with the Physician Assistant. There was a blood work performed (results not provided). It was reported that the adverse event had improved at the time of the report. All telephone attempts to contact the reporter have been unsuccessful. Follow up information was received from a Physician Assistant (P.A) on 23-JUN-2009 via telephone reported that the patient with no pertinent medical history or known drug allergies was vaccinated with the first dose of GARDASIL (Lot # 661846/1312X) on 13-JUN-2009. On 13-JUN-2009 the patient was very anxious and hadn't eaten since the night before. There were no concomitant medications and no other vaccinations given that day. After having fainted for only a few seconds, the patient was monitored in the office for the next 45 minutes. The vital signs and blood sugars were normal, but the patient was nauseous, lethargic and pale. She was transported to the emergency room. It was unknown what tests - other than blood work - were performed. The event was considered disabling for about five hours. The patient had fully recovered. The reporter considered fainted, nauseous, lethargic and pale to be significant disability/disabling. No further information is available." None"vital sign, 06/13/09, normal; blood glucose, 06/13/09, normal" . During the same period patient was treated with None. Patient recovered.

HPV (GARDASIL) Side Effects Report #350361
HPV (GARDASIL) vaccine side effect was reported on 06/29/2009. Female patient, 17.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Pallor, "Patiet received Menactra, Gardisil, Adacel, and, and Havrix. She became pale and nauseated. Her skin was cool and clammy. Her head went down appearing as if she was faint, but she was able to hear and answer questions. Spirits of ammonia applied. BP was 70/40. She was then placed in a supine position with legs elevated. Her symptoms then subsided and BP returned to 110/70. She stayed at the state health center for one hour accompanied by her mother who drove her home." nonenone known . During the same period patient was treated with none. Patient recovered.

HPV (GARDASIL) Side Effects Report #350390
HPV (GARDASIL) vaccine side effect was reported on 06/26/2009. Female patient, child 10.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Pallor, "Client immediately suffered syncope episode after injection of GARDASIL. She was pale, clammy to touch and non-responsive for approx 1 minute. BP 77/54. Client awoke, was given sprite to drink and was observed for approx. 20 min. Client appeared fully recovered when she left with her mother. Followed-up 6/26/09, mother states client is well." NoneAllg.; PCN . Patient recovered.

HPV (GARDASIL) Side Effects Report #350416
HPV (GARDASIL) vaccine side effect was reported on 06/26/2009. Female patient, 19.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Pallor, "Fainted about 2 - 3min after receiving vaccine with seizure like activity (probably secondary to fainting) pale, nauseous, shaky, low BP. Seemed to recover after 15 min, then fainted again(decrease in BP 84/56) elevated feet another 10-12 minutes, recovered. Took liquids. Walked out OK with mother" NoneADHD; Ocular albinisimNone . Patient recovered.

HPV (GARDASIL) Side Effects Report #350555
HPV (GARDASIL) vaccine side effect was reported on 06/30/2009. Female patient, 14.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Pallor, "fainted immediatley with slight jerking motion. B/P 80/40, pulse 60. Woke a couple seconds later very cold, shaky, 80/50. Very diaphoretic, pale, weak. Client did not eat this AM. Had ~bad taste in mouth~ Client stayed lying down for 30 minutes before she felt strong enought to stand. Last B/P before leaving was 80/50. Gave her a glass of apple juice." none . Patient recovered.

HPV (GARDASIL) Side Effects Report #350646
HPV (GARDASIL) vaccine side effect was reported on 07/01/2009. Female patient, 15.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Pallor, "Pt was also given T-DAP- MENACTRA, HEP A Pt was given GARASIL (LA), within 30 sec. Pt became pale. unresponsive arms & legs became rigid, lasted for aprox 2 min. After that Pt was pale for aprox 10 min. pulse cx 81 HR 113 pulse cx 91 H.R. 114, pulse cx 73, HR 81, pulse cx 71, HR. 46. B.P. 118/70 4:35 pt. States feeling better - 4:30 ambulance called, pulse cx in 70's H.R. in 40's - B.P. 106/72. Pt no longer pale & able to stand Pt was alert, conscious, coherent GCS (15) when sent to ER. Pt. received total total of 4 shots, #1 T-DAP (LA) #2 GARDASIL #3 HEP A, #4 MENACTRA. Pt states she doesn't remember the 4th shot. When she woke up, she didn't know where she was on the shots. After 10 min she did remember getting shots except for the 4th shot." . Patient recovered.

HPV (GARDASIL) Side Effects Report #350709
HPV (GARDASIL) vaccine side effect was reported on 06/19/2009. Female patient, 14.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Pallor, "Pt. received HPV vaccine for 1st time on 6-17-09 at approximately 16:35 as part of P.E. (Pt. had received PPD in other forearm 5 min. prior). At 16:40 pt. in seat & noted to be pale said she would ~pass out~ & was placed on table. MD called. Vitals assessed. Pt. drank water, rested and walked out of clinic shortly after." NoneHR 70 BPM; BP 110/70 -> after event . Patient recovered.

HPV (GARDASIL) Side Effects Report #350778
HPV (GARDASIL) vaccine side effect was reported on 07/06/2009. Female patient, 14.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Pallor, Fainted after recieving immunizations.Turned pale. Fell to the floor. Patient passed out for 10 seconds. Stated that she felt dizzy when she came to. . Patient recovered.

HPV (GARDASIL) Side Effects Report #350877
HPV (GARDASIL) vaccine side effect was reported on 06/29/2009. Female patient, 14.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Pallor, Pt. Was given 1st GARDASIL shot today. Pt. passed out after feeling faint and sick to stomach. Pt. was pale but opened eyes and was alert after Ammonia salts. NoneNone . Patient recovered.

HPV (GARDASIL) Side Effects Report #351154
HPV (GARDASIL) vaccine side effect was reported on 07/09/2009. Female patient, 18.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Pallor, Pt A and O x3. HPV given L deltoid. Pt passed out 1-2 secs after vaccine given. Pt arousable. A and O x 3. Vital signs stable. Pt tearful and pale. Pt states she had not eaten or drank anything. Pt given 8 oz apple juice. Spina Bifida Occulta; acne; Headache; asthma; allergies . Patient recovered.

HPV (GARDASIL) Side Effects Report #351304
HPV (GARDASIL) vaccine side effect was reported on 07/13/2009. Female patient, 17.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Pallor, "Information has been received from a certified medical assistant concerning a 17 year old female patient who on 18-JUN-2009 was vaccinated with 0.65 ml of the first dose of GARDASIL (Lot:661766/0652X). There was no concomitant medication. Immediately after vaccination the patient had a seizure. They called an ambulance, and by the time the ambulance got there the patient was fine and laughing and did not need to leave in the ambulance. Additional information has been received from an office person who stated that the patient's DOB was 13-MAY-1992. After the 17 year old female patient received GARDASIL she began to shake, became unconscious and had a tonic- clonic seizure that lasted for 15 seconds. An Ambulance was called to take the patient to the hospital. The patient ~came to and was fine~. The patient was not postictal, had no rash and had no difficulty breathing. The patient's blood pressure and EKG were normal. The patient's mother did not want the patient to go to the Emergency Room. The physician evaluated the patient and recommended that the patient have a CT scan of the brain and an EEG. The patient was approved for both diagnostic tests. The patient's mother took the patient home. Upon internal review, tonic-clonic seizure was considered to be an Other Important Medical Event. Additional information has been requested. 7/16/09 PCP recs rec'd. WCC 6/18/09 with normal exam except hematoma under 2 toe nails. HPV#1 given. Pt immediately devloped pallor and syncope with tonic/clonic seizure activity lasting 5-10 sec. EMS called but parent declined transport." hematoma under 2 toe nailsUnknown"electrocardiogram, 06/18/09, normal; blood pressure, 06/18/09, normal. Labs and Diagnostics: CT brain (-). EEG normal." . During the same period patient was treated with None. Patient recovered.

HPV (GARDASIL) Side Effects Report #351359
HPV (GARDASIL) vaccine side effect was reported on 07/13/2009. Female patient, 14.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Pallor, "1600 pt passed out, in the lobby on their way out home. Became pale, non responsive, US taken & showed for few minutes as inquiry noted. MD notified. regained consciousness & recovered." NoneNone . Patient recovered.

HPV (GARDASIL) Side Effects Report #351553
HPV (GARDASIL) vaccine side effect was reported on 07/09/2009. Female patient, child 11.9 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Pallor, "Child almost bumped in the door as she left the office after the 1st GARDASIL and felt dizzy but got betters quick. Today after the 2nd GARDASIL - she got dizzy again and very pale (within minutes of the shot) - she recuperated very quickly with no ~LOC~." None . Patient recovered.

HPV (GARDASIL) Side Effects Report #351770
HPV (GARDASIL) vaccine side effect was reported on 07/17/2009. Female patient, 18.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Pallor, "PATIENT CAME TO HEALTH DEPARTMENT FOR COLLEGE IMMUNIZATIONS. NERVOUS ABOUT SHOTS. DETERMINED NEEDED Tdap(FOR COLLEGE ENTRY), MENACTRA, AND GARDASIL (LAST 2 FOR COMPLETE IMMUNIZATIONS SERIES). EXPLAINED SIDE EFFECTS. TDAP GIVEN IN LEFT DELTOID AND GARDASIL GIVEN IMMEDIATELY AFTER IN LEFT UPPER ARM. PATIENT SAID THAT SHE DID NOT FEEL WELL, BECAME PALE AND FAINTED. LOWERED TO FLOOR FROM CHAIR. PALE, AND HAD WHAT APPEARED TO BE A SEIZURE. WITHIN SECONDS WAS TALKING BUT COMPLAINED OF BEING WARM. B/P 72/59 PULSE 84/MIN,NEVER STOPPED BREATHING. 911 CALLED AND RESPONDED B/P INCREASED AND PATIENT SITTING IN CHAIR AND SAYS FEELS BETTER. SHE SIGNED THAT SHE DIDN'T WANT TO GO TO ER AND THEY LEFT. WITHIN ABOUT 4 MINUTES SHE FAINTED AGAIN. LOWERED TO FLOOR AND PATIENT WAS TALKING BUT LETHARGIC. B/P WAS 112/ FIRST RESPONDERS RETURNED AND SITTING IN CHAIR B/P 108/ DRINKING SOME JUICE AND TALKING WITH 1ST RESPONDERS. AFTER APPROX 5 MINUTES WHILE FIRST RESPONDERS WERE STILL HERE SHE FAINTED AGAIN AND APPEARED TO HAVE A SEIZURE. FIRST RESPONDERS LOWERED HER TO FLOOR AND WITHIN SECONDS AGAIN SHE WAS RESPONDING AND TALKING. DECISION TO TRANSPORT TO ER. 7/24/09 ER records received DOS 7/17/09. Final Diagnosis: Vasovagal syncope. Patient reports receiving 2 shots today and passing out before receiving the 3rd. Total of 3 episodes syncope. Anxious. Presents for evaluation of syncope. ICD-9 Codes: 780.2" NO.BUT AFTER THE INCIDENT PATIENT SAYS SHE HAS PASSED OUT WHEN SHE HAD SHOTS AS A CHILD AND LAST YEAR PASSED OUT AT SCHOOL AND NNO. 7/24/09 ER records received DOS 7/17/09. Phobia of needles. would pass out as a child."7/24/09 ER records received DOS 7/17/09. LABS and DIAGNOSTICS: EKG WNL. Urinalysis - Cloudy, Leukocytes (+), Epithel. moderate, bacteria many. Amorph 2+." . Patient recovered.

HPV (GARDASIL) Side Effects Report #352079
HPV (GARDASIL) vaccine side effect was reported on 07/15/2009. Female patient, 17.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Pallor, "Information has been received from a patient's mother concerning an 18 year old female with no allergies who on 08-JUN-2009 was vaccinated with her first dose of GARDASIL. Concomitant therapy included YASMIN. Then within a short time after the first dose the patient's arm felt heavy, her face became pale, her body went limp and her arms and legs were flailing. This only happened for a couple of seconds and then she came to and her color in her face came back. The patient stayed at the office for ten more minutes and was given water and sugar since she had an empty stomach and was then fine to leave. No labs and diagnostic tests were performed. The patient slept the rest of the day, and was fine. No further information is available." UnknownNone . During the same period patient was treated with drospirenone (+) ethinyl. Patient recovered.

HPV (GARDASIL) Side Effects Report #352177
HPV (GARDASIL) vaccine side effect was reported on 07/15/2009. Female patient, 15.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Pallor, "Information has been received from a registered nurse concerning a female patient who ~3 weeks ago~ on approximately 26-MAY-2009, was vaccinated with a dose of GARDASIL. Concomitant therapy included MENACTRA and other unspecified vaccines which were also given. On approximately 26-MAY-2009, after receiving the dose of GARDASIL the patient experienced syncope and turned blue. Oxygen was administered. The patient sought medical attention. The patient recovered within 20 minutes after the dose of GARDASIL was given. Follow-up information was received from a registered nurse concerning a 15 year old female patient. It was reported that on 12-MAY-2009, the patient received the first dose of GARDASIL (LOT # 661703/0651X). On 12-MAY-2009 the patient concomitantly received Tdap (manufacturer unknown) (LOT # C3029AA) and Hep A (manufacturer unknown) (LOT # AHABB319AA). It was reported that the patient did not receive concomitantly MENACTRA. After the patient had received GARDASIL, the patient became pale and light-headed. The patient never completely fainted. The patient's lips turned blue and the patient required oxygen for about 10 minutes. It took the patient ~a long time before she felt normal~. It was reported that the patient had eaten lunch before going to the physician's office. No further information is available." UnknownUnknown . Patient recovered.

HPV (GARDASIL) Side Effects Report #352064
HPV (GARDASIL) vaccine side effect was reported on 07/21/2009. Female patient, 18.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Pallor, "Patient was given GARDASIL on 7/20/09 at 1430 and seconds later patient stated she was not feeling well and asked for water. Patient then turned pale and and began falling backwards. Patient was on exam table and lowered to pillow - No injury from this. Patient lost consciousness for 30 seconds and then regained consciousness. Patient was given juice and re examined by doctor. Her father picked her up and drove her home. Advised patient if she has any SOB, swelling up tongue or throat call 911." SyncopeNKDA - No other birth defects/medical conditions I'm aware. . During the same period patient was treated with "Sertraline, 50 mg 1.5 take daily". Patient recovered.

HPV (GARDASIL) Side Effects Report #352260
HPV (GARDASIL) vaccine side effect was reported on 07/17/2009. Female patient, 21.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Pallor, "Pt fell to floor post GARDASIL vaccine #2, 10 minutes post vaccine. Alert, responsive, pale. BP 70/50 - 78/60 - 86/60 - 92/70 - 98/70 - (Bumped L head.) WNL. Ice packs to head." NoneNoneMonitored q5 minutes; discharged w/parent 10:45 . During the same period patient was treated with None. Patient recovered.

HPV (GARDASIL) Side Effects Report #352398
HPV (GARDASIL) vaccine side effect was reported on 07/24/2009. Female patient, 15.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Pallor, "Immediately after receiving Tdap, Menactra, and HPV at 3:15 pm patient reported feeling dizzy, weak. Pale, sweating, no loss of contiousness, pt. placed in supine position on floor with legs elevated. BP 98/68, p. 88, 3:20 pm reported feeling better, 98/64, p. 84, color improved and able to sit upright. 4 pm, released in care of brother, pt. advised no driving today, to ER increase symptoms. Verbalized understanding." nonenone . Patient recovered.

HPV (GARDASIL) Side Effects Report #352548
HPV (GARDASIL) vaccine side effect was reported on 07/27/2009. Female patient, 15.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Pallor, "Had a syncopal episode in the parking lot. Received HPV, Hep A and TDAP. Told mom that she had ringing in the ears and felt dizzy leaving the office. When she reached the parking lot she was falling down and dizzy and started to pass out. Called to the parking lot and she was awake,pale,talking and sitting on the ground. Assisted to a wheelchair and brought back to the office." None"Blood pressure at 15:32 in the office for physical blood pressure was 143/71, after episode and back in office B/P was 94 /56" . During the same period patient was treated with None. Patient recovered.

HPV (GARDASIL) Side Effects Report #352629
HPV (GARDASIL) vaccine side effect was reported on 07/28/2009. Female patient, child 11.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Pallor, "Tdap, Varicella, MCV4, & Gardasil were completely administered at approximately 1:50 p.m. on 7/28/09; When the family was checking out at the clerk's window, the patient told her mother she felt weak. The patient leaned against the wall and the mother assisted her to the floor. When the nurse arrived at the front, the patient was awake, alert, & oriented. She was clammy and c/o nausea. The nurse assisted her to the bathroom and the patient sat down. B/P was 72/46, Respirations 14, regular; Skin cool and damp, pale. After about 15 minutes, patient began feeling better, color had returned." . Patient recovered.

HPV (GARDASIL) Side Effects Report #352659
HPV (GARDASIL) vaccine side effect was reported on 07/21/2009. Female patient, 25.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Pallor, "Patient c/o lightheadedness, ~feeling faint~ directly after vaccination (had no c/o after 1st shot) Pt. became diaphoretic, pale-reclined with feet up, cool compresses-color returned to face. ~felt as if lost consciousness~ fro a few seconds. Pt. had eaten breakfast and exercised prior to coming in." None . Patient recovered.

HPV (GARDASIL) Side Effects Report #352761
HPV (GARDASIL) vaccine side effect was reported on 07/24/2009. Female patient, 16.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Pallor, "Shortly after receiving vaccine, while sitting on table she became ashes in color, used ammonia inhaler but she passed out to lying down position on table. Ice was applied to neck and forehead. Mother was present. I was forewarned as pt. fainted with 1st HPV vaccine. About 20 minutes later pt. stated she was ok, left with family to go eat." NKNKNone . During the same period patient was treated with NK. Patient recovered.

HPV (GARDASIL) Side Effects Report #352774
HPV (GARDASIL) vaccine side effect was reported on 07/30/2009. Female patient, 18.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Pallor, "Immediately following administration of vaccines, client became pale, hot, and dizzy. BP 74/40. Had client place head between knees, cold pack applied to back of neck, juice given. 10 minutes later BP 90/72, HR 62. Client escorted by RN to another room to rest and have another juice. Health aid remained with client. BP 118/78 15 minutes later. Client felt fine, color back in face, no longer hot or dizzy. Client driven home by her friend." . Patient recovered.

HPV (GARDASIL) Side Effects Report #352777
HPV (GARDASIL) vaccine side effect was reported on 07/21/2009. Female patient, child 12.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Pallor, "Patient recedived vaccines. While patient was leaving the building she fainted. Patient quickly awakened, but was confused for a short time. Patient then had nausea/vomiting for a short time. Patient was given a cool wash cloth and door opened for fresh air. Blood pressure obtained 98/62. Patient's pink color started to return. Patient given sprite and peanut butter crackers after nausea and vomiting gone. Patient said she was feeling better. She then was stood up after approximately 15 minutes adn sat in a chair and recovered fully before leaving with her mom." none knownnone known . Patient recovered.

HPV (GARDASIL) Side Effects Report #352891
HPV (GARDASIL) vaccine side effect was reported on 07/31/2009. Female patient, child 12.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Pallor, "Incident occured 7-30-09. After administration of HPV and Varicella vaccine,client was escorted to a chair to be obserbed for 15 min. While seated in the chair, mother obserbed that the client was pale, lips cyanotic. Client proceeded to lose conciousness briefly (30 sec) vomited repeatedly approximately 5x." n/aunknown . During the same period patient was treated with unknown. Patient recovered.

HPV (GARDASIL) Side Effects Report #352926
HPV (GARDASIL) vaccine side effect was reported on 07/20/2009. Female patient, child 12.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Pallor, - L.O.C for 2 sec. - Paleness in face * Treatment -> lay down with elevated legs NKDA . Patient recovered.

HPV (GARDASIL) Side Effects Report #352987
HPV (GARDASIL) vaccine side effect was reported on 07/31/2009. Female patient, 16.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Pallor, "Information has been received from a registered nurse concerning a 16 year old female patient with a history of acne and no known drug allergies who on 27-JUL-2009 was vaccinated with a dose of GARDASIL (Lot: 661954/1496X). The patient did not receive any concomitant vaccines when the GARDASIL was administered to the patient. Concomitant therapy included tetracycline. There were no concomitant vaccines. On 27-JUL-2009, within five minutes of receiving GARDASIL, the patient became light headed, fainted and passed out while sitting in the waiting room with her mother. Her left arm had seizures movement and her right arm had slight seizure movement, the patient had a tonic-clonic seizure which lasted for 2 to 3 seconds. The patient abruptly awoke. The patient had not eaten prior to the physician's visit and prior to the GARDASIL vaccination. The nurse stated that the patient was given something to eat and drink after the incident had occurred. The patient was white and shaky for a while. On the same day, 27-JUL-2009, the patient recovered. The Registered nurse did not consider the patient's experience to be disabling or life-threatening. The registered nurse stated that she spoke with the patient's mother via a telephone call on 27-JUL-2009 and 28-JUL-2009. The patient's mother stated that the patient ~was doing fine~. Upon internal review tonic-clonic seizure was considered as other important medical event. Additional information has been requested." AcneNone . During the same period patient was treated with tetracycline. Patient recovered.

HPV (GARDASIL) Side Effects Report #353009
HPV (GARDASIL) vaccine side effect was reported on 08/03/2009. Female patient, child 11.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Pallor, "Syncopal episode occurred 2 minutes after immunization. Assited to supine position with legs elevated. B/P 84/60. HR 64. Oxygen saturation 98%. Cool cloth to forehead & neck. Lips pale, skin moist. C/O nausea & dizziness. Recovered after 10 minutes. Denied further symptoms." NoneNone . Patient recovered.

HPV (GARDASIL) Side Effects Report #353034
HPV (GARDASIL) vaccine side effect was reported on 07/28/2009. Female patient, 16.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Pallor, "Approx. 2 min after injections, became pale, nauseated, dizzy, + felt ~hot~. Vital signs stable. After 15~ up to chair. Denied nausea or dizziness, color improved, skin warm & dry." None knownNone . Patient recovered.

HPV (GARDASIL) Side Effects Report #353026
HPV (GARDASIL) vaccine side effect was reported on 08/04/2009. Female patient, 17.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Pallor, "Was doing fine after first after first shot, received 2nd series and next day went to dr. from school complaining of blurred vision, sick to stomach, and bad headache, fever and heart palpitations. Felt like was going to pass out. Went to dr. had tests and was in bed for 3 days. Blood tests came back low.. White, red and platelets.. Told 2 wait and be tested again in a few weeks. When tested again was sent to hospital and then diagnosed with ITP Syndrome and given medication.. Did not work, so then was hospitalized because blood was so low at serious risk for a stroke, was given another dose of globin and spent night at hospital.. A few weeks later, took blood tests again everything was still low, was put on highest dosage of Prednisone 4 3 weeks.. Blood levels raised and stabilized 4 a few weeks.. Latest has been diagnosed with ITP/Evans Syndrome and told would probably turn into Lupus, will have to visit hospital on a regular basis to be monitored.. A permanant disease, Rheumatologist and blood disorder doctors from 2 major hospitals agree this illnes was created by the Gardasil Vaccine and written in their reports. 8/10/09 PCP medical records received DOS 1/2/09 to 3/18/09. Assessment: Low platelet count. Hives/urticaria thighs and lower legs, itching after tanning session. Has started oral contraceptives. Heart palpitations, nausea, feverish. Headache, ears hurt, lightheaded. Looks pale. Excused from PE. 8/10/09 Hospital records and Oncology/Hematology consult, Rheumatology Consult, DOS 4/9/09 to 4/27/09. Assessment: Thrombocytopenia, anemia, neuropenia, positive lupus anticoagulant, elevated PT/PTT. Patient presents with thrombocytopenia, anemia, excessive vaginal bleeding. Had bad 'virus' with fevers, cough, headache, poor sleeping and sweating. Missed school. IVIG therapy. Hair is falling out. Energy levels decreased, pale, diffuse bruises, petechia over lower legs. Tightness in neck. Wheezing. 8/10/09 Hematology consult - second opinion, Rheumatology report DOS 4/21/09 to 5/19/09. Assessm" No"allergies to penicillin. 'Easy bruiser~. Penicillin allergy. 'Ear tubes', dental extractions."ITP/Evans Syndrome... Will eventually turn into Lupus. LABS and DIAGNOSTICS. 1/2/09 to 3/18/09: Platelets 63 (L). 4/9/09 to 4/27/09: CBC - RBC 3.27 X10'3 (L) Hemoglobin 10.2 g/dl (L) Hematocrit 30.3% (L) Platelets <5 X10'3 (L) Myeloc . During the same period patient was treated with None. Patient was hospitalized Patient recovered.

HPV (GARDASIL) Side Effects Report #353143
HPV (GARDASIL) vaccine side effect was reported on 08/04/2009. Female patient, 14.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Pallor, "Within 5 min of receiving HPV #3 in a semi-lying down position she started having some tremors and passed out. B/P at that time was 102/59 with a pulse of 49. She was pale around lips. She was more woozy then passed out. She was placed in flat supine position and given juice & crullers. She stayed supine for another 30 min. When she started to get up she fainted at that time. At that time her BP was 94/58, P = 40. She was observed over the next 30-35 min and her BP increased to 107/64 with P = 40. Color much better. She was observed over the next hour and a half with BP & P observed every 15 min. She was observed for 2 hrs since coming in with BP 112/68." NoneNoneNone . During the same period patient was treated with Tetracycline 500mg cap twice a day; PPD. Patient recovered.

HPV (GARDASIL) Side Effects Report #353305
HPV (GARDASIL) vaccine side effect was reported on 08/06/2009. Female patient, 15.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Pallor, "APPROXIMATELY 2 MINUTES AFTER RECEIVING IMMUNIZATION PT BE CAME WEAK AND DIZZY. ACCORDING TO FATHER PT ~SLUMPED OVER AND JERKED A FEW TIMES~. PT NOTED TO BE VERY PALE." NoneNoneINITIAL VITALS: B/P 104/59 HR 33 R 14 SPo2 98% -HEART MONITOR SHOWED NORMAL SINUS RHYTHM. PT WAS PLACED IN TRENDELENBURG POSITION AND OXYGEN WAS ADMINISTERED AT 2L NASAL CANNULA. AFTER ABOUT 20 MINUTES PT SAID SHE FELT BACK TO BASELINE. V . During the same period patient was treated with None. Patient recovered.

HPV (GARDASIL) Side Effects Report #353330
HPV (GARDASIL) vaccine side effect was reported on 08/06/2009. Female patient, 15.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Pallor, "Became pale 5 min after injection. Legs elevated. Fainted in chair. Eased down to floor by staff x 2. Easily aroused, oriented. BP 107/62. Skin warm, dry. CRT < 3 sec. Rested on floor x 5 min. Rested in chair x 10 min. Given juice/crackers. No injury sustained. Left with mother in stable medical condition." NonePediazole . During the same period patient was treated with None. Patient recovered.

HPV (GARDASIL) Side Effects Report #353418
HPV (GARDASIL) vaccine side effect was reported on 08/06/2009. Female patient, 14.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Pallor, "Pt was nervous prior to receiving vaccinations and after 5th immunization pt stated ~I feel weak~. Color from lips went pale. Gave pt orange juice. Pt's mother said daughter had not eaten since breakfast. Applied cold compress to neck. Took vital signs. Vital signs within normal range. MD notified. MD assessed pt. MD released pt to parent. Advised pt. to eat prior to vaccinations per MD." NoneNone"Vital signs, within normal range" . During the same period patient was treated with None. Patient recovered.

HPV (GARDASIL) Side Effects Report #353755
HPV (GARDASIL) vaccine side effect was reported on 07/30/2009. Female patient, 13.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Pallor, "Syncope, vomiting, grey skin tone. Syncope lasted ~20 sec, patient came to and combative, then began vomiting intermittently and skin tone grey X 30min. VSS called squad and transported to Children's Hospital. Patient continued to throw up in ambulance. Observed in ER. Specific testing not done due to patient's strong history of syncope. In the past patient had tilt table test for diagnosis of vasodepressor syncope. Recently (2/09) pt had EKG and Echo for innocent murmur before nasal surgery. Patient passed out every time in ENT's office when painful stimulus per mom." HematuriaVasodepressor Syncope . Patient recovered.

HPV (GARDASIL) Side Effects Report #354037
HPV (GARDASIL) vaccine side effect was reported on 08/05/2009. Female patient, 16.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Pallor, "Vaccine was administered, patient became dizzy 30 seconds after shot. Patient was pale, diaphoretic & nauseous. Symptoms lasted about 45 minutes. BP dropped to 90/50 & pulse to 50/min. 8/20/09 PCP note received DOS 8/4/09. After shots pt became naseated, pale, diaphoretic, dizzy and had difficulty breathing. BP dropped to 90/50 and pulse into the 50's. Sx lasted ~45 minutes with return to baseline. Vax record states pt ~passed out~." 8/20/09 PCP note received DOS 8/4/09 Never experienced these symptoms with previous shots. . Patient recovered.

HPV (GARDASIL) Side Effects Report #354039
HPV (GARDASIL) vaccine side effect was reported on 08/11/2009. Female patient, child 12.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Pallor, "Approximately 20 seconds after the GARDASIL with no warning she passed out and became unresponsive for 10 seconds. She was very pale, diaphoretic and had a heart rate of about 64. When she came too she was unable to stand and had fully dilated pupils and so could not see. I managed to get her to a room with a table and lay her down. She gradually became fully responsive but had dilated pupils for about 7 minutes from the start of the reaction. Being concerned about anaphylaxis I called 911 while she was not fully responsive, they came and checked vitals, BP 104/68, glucose 94. At no time was her breathing compromised. This whole episode lasted about 25 minutes, after which she fully recovered." . Patient recovered.

HPV (GARDASIL) Side Effects Report #354128
HPV (GARDASIL) vaccine side effect was reported on 08/13/2009. Female patient, child 11.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Pallor, Pt felt lightheaded and was pale. . Patient recovered.

HPV (GARDASIL) Side Effects Report #354293
HPV (GARDASIL) vaccine side effect was reported on 08/14/2009. Female patient, child 9.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Pallor, "PT. RECEIVED HPV AND VARICELLA IMMUNIZATIONS. UPON LEAVING, WHILE WALKING IN HALLWAY, MOTHER STATES THAT PT. LOOKED PALE, FAINTING AND HITTING HEAD AGANIST WALL. PT. TAKEN TO EXAM TABLE IN CLINIC-VITAL SIGNS B/P118/68, P-68,R-16,ELEVATED LEGS WHILE PT. LYING DOWN, RESPONDED TO TIME, PLACE, DAY, PURPOSE OF VISIT. CHECKED FOR ANY BRUISING, OPEN AREAS,LUMPS, BLEEDING, NON VISIBLE. STATED COULD SEE ME. MONITORED FOR 20 MINUTES, NO OTHER S/S NOTED. MOTHER STATED THIS EPISODE OF FAINTING OCCURED WHEN 5YRS. OLD DURING A FINGERSTICK. MOTHER STATED THAT THIS TIME, PT. ~WORKED HERSELF UP~ OVER ~SHOT~. ADVISED MOTHER (SANTOS ADELA BARRAGAN)TO TAKE PT. TO ER FOR FURTHUR EVAL, HOWEVER, STATED PT. WOULD BE FINE AND SHE WOULD TAKE HER HOME FOR DINNER. IF ANY OTHER S/S OCCURRED, SHE WOULD THEN TAKE HER TO ER. AT INITIAL ASSESSMENT MOTHER DID NOT MENTION PREVIOUS EPISODE OF FAINTING-PT. DID HAVE LUNCH." MOTHER STATES NONENONE-REPORTED BY MOTHERNONE . During the same period patient was treated with NONE. Patient recovered.

HPV (GARDASIL) Side Effects Report #354342
HPV (GARDASIL) vaccine side effect was reported on 08/14/2009. Female patient, 16.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Pallor, "Information has been received from a registered nurse concerning a 16 year old female who was vaccinated with the ~first dose~ of GARDASIL (injection, lot# not reported) in the ~last week~ (approximately 27-JUL-2009). Concomitant therapy included MENACTRA. The nurse stated that the patient received her first dose of GARDASIL and ~2 minutes later the patient felt nauseated and she turned white, her lips were white~. The nurse added that the patient looked like she maybe going into shock at that time. The nurse took blood pressure and checked her heart rate which were fine and they had the patient lie down for 5 to 10 minutes and then she started to feel better. The patient fully recovered after 20 to 30 minutes. The patient was given water and grapes. Upon internal review, shock was determined to be an other important medical events. Additional information has been requested." Unknown"blood pressure, 07/27?/09, fine; diagnostic laboratory, 07/27?/09, heart rate: fine" . Patient recovered.

HPV (GARDASIL) Side Effects Report #354430
HPV (GARDASIL) vaccine side effect was reported on 08/12/2009. Female patient, 19.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Pallor, Immediately became pale and fainted - revived in at 15 seconds but couldn't remember what happened. NoneNone . Patient recovered.

HPV (GARDASIL) Side Effects Report #354632
HPV (GARDASIL) vaccine side effect was reported on 08/19/2009. Female patient, 13.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Pallor, "Near Fainting Heart rate 52 pale poor cap refill, dizzy and nausea." nonenear faiting . Patient recovered.

HPV (GARDASIL) Side Effects Report #354654
HPV (GARDASIL) vaccine side effect was reported on 08/19/2009. Female patient, 15.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Pallor, "stood up after injection and had probable vaso vagal response with full body tremor, lips turned pale, eyes rolled back, assisted to exam table tremors lasted a few seconds-less than a minute, vital signs taken WNL" nonenonenone . During the same period patient was treated with none. Patient recovered.

HPV (GARDASIL) Side Effects Report #354665
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: Pallor, "Administered four vaccines during immunization clinic visit. Within five minutes of injection, client became very pale, c/o of dizziness and lightheadedness, H/A and buzzing in ears. Client did not lose consciousness or fall. Client eased to floor, feet elevated, cool pack to back of neck and client given sucker. CLient alert during entire process. After 10-15 minutes client's status improved although she still had H/A and buzzing in ears, client changed to sitting position and then standing position over next 5 - 10 minutes and left office under the mother's care. Client's gait steady and she ambulated without assistance. Mother advised to have child eat once home and lay down. Mother called approximately one hour after leaving office to report, client dizzy intermittently, had severe H/A and buzzing in ears. Advised mom to notify MD of s/s." nonelatexNone . During the same period patient was treated with None noted. Patient recovered.

HPV (GARDASIL) Side Effects Report #354671
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: Pallor, "Pt received the Gardasil series of shots on July 20, 2007, Sept. 26,2007 and Feb. 20, 2008. In Jan. 2009, she told me (her mother) about a large lump on her neck. It had clearly been there for sometime based on it's size (4cm x 3cm) and consistency. The pediatrician thought this was a benign swollen lymph node, but subsequently, this was biopsied by a surgeon and Jennifer was diagnosed with Hodgkin's Lymphoma, nodular sclerosis type. While we understand that there is not live virus in the vaccine, we believe that there is an association between the generated immune reaction to the HPV recombinant protein and Hodgkin's Lymphoma. My daughter is now undergoing chemotherapy for her cancer. I sincerely hope the CDC will collect data on Gardasil and the onset of Hodgkin's lymphoma in young girls. 9/1/09 PCP medical records received DOS 7/15/08 to 1/19/09. Patient presents with anxiety, migraines, sinusitis. 9/1/09 PCP medical records received 2/17/09 to 7/17/09. Assessment: Lymphadenopathy. Patient presents with headache frontal, associated with nausea and vomiting. Three migraines last two weeks, throbbing, photophobia. Sore throat, unable to swallow. Cervical lymph nodes bilateral. Rash on abdomen. Swollen cervical lymph nodes 2 months left side. 9/21/09 Received ENT & Heme/Onc consults. FINAL DX: Hodgkins lymphoma, nodular sclerosing, stage IIA. Records reveal patient was pale & had firm left clavicular lymph node. Excisional biopsy done 7/23/09 revealed diagnosis. Tx w/chemotherapy & possibly radiation tx when chemo completed." 9/1/09 PCP medical records received DOS 7/15/08 to 1/19/09. Minocycline allergy. Fasting glucose elevated. 9/1/09 PCP medical records received 2/17/09 to 7/17/09. Allergy to nuts. 9/21/09 Received medical records w/PMH: acne under treatment. migraines. Allergy: tetracycline. Family hx: cancer & leukemia."CBC, CMP, CT, PET, supraclavicular lymph node biopsy. 9/1/09 PCP medical records received DOS 7/15/08 to 1/19/09. LABS and DIAGNOSTICS: Strep (-). 9/1/09 PCP medical records received 2/17/09 to 7/17/09. LABS and DIAGNOSTICS: Rapid Strep" . Patient recovered.

HPV (GARDASIL) Side Effects Report #354755
HPV (GARDASIL) vaccine side effect was reported on 08/18/2009. Female patient, 15.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Pallor, "Took my three daughters to their doctors for the GARDASIL shot. One daughter was fine, no reaction. The youngest daughter -11 years old- felt nauseous and went pale and had a mild headache. My oldest daughter -15 years old- is the one who had the severe reaction. I believe she had a seizure and not just fainted. She first complained of feeling nauseous then dizziness. Her eyeballs rolled in the back of her head and her whole body went stiff. I could barely lift her stiff legs on the table and lay her head down. After about a minute of calling her name, she finally woke up but was very pale and had a bad headache. The doctor just blew me off, but I will not let my daughters receive this shot again." "My oldest daughter has seasonal allergies, ovarian cysts, but no other known medical conditions. My youngest daughter had a fever seizure as an infant we think because of the pertussis in the APT shot. She also had ADHD. My middle daughter -the one who had no reaction to the shot- also had ADD but no other medical conditions."None . Patient recovered.

HPV (GARDASIL) Side Effects Report #354784
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: Pallor, "Patient had first Gardisil injection at her pediatric clinic without complications approximately 1 year ago. Gave 2nd Gardisil 0.5ml injection in L Deltoid on 8/7/09. Patient stated that it hurt then started to lean to the left side. Her body went rigid, hands clenched at chin level. She quickly sat up and opened eyes and became responsive. She was pale, diaphoretic, radial pulse of 58 bp 90/60. Placed her head between knees and did slow deep breathing. Patient stated she felt better. VS more stable...pulse 64, bp 96/62. Aproximately 10 minutes later, patient became pale, diaphoretic, dizzy c/o neck pain. Radial pulse 58, thready, bp 92/58. Staff called 911. Kept patients head down, slow breathing until EMT's arrived. Gave EMT's report of sx and vitals. Patient vomited x 2. Patient recovered. EMT's stated that she vasovagaled from the injection. She had not eaten dinner the night before or breakfast or had anything to drink since the night before which may have contributed to the fainting as well. Patient did not want to go to ER...father signed release, patient left with dad and boyfriend." Possible dehydration- patient told EMT's that she had not had anything to eat or drink since the day before her injection."No Allergies, Migraine headaches, Smoker." . Patient recovered.

HPV (GARDASIL) Side Effects Report #354927
HPV (GARDASIL) vaccine side effect was reported on 08/17/2009. Female patient, child 12.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Pallor, "5 min after rec GARDASIL, HAVRIX & VARIVAX inj - pt became pale, lightheaded - nausea ringing in ears - pt laid on exam table recovered." None . Patient recovered.

HPV (GARDASIL) Side Effects Report #355062
HPV (GARDASIL) vaccine side effect was reported on 08/24/2009. Female patient, 18.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Pallor, "Gave vaccines to pt while she was lying flat on the exam table. Approximately 30 seconds later, she passed out and had several jerky upper body movements. She then regained conciousness after about 30 seconds and was pale and slightly clammy. Pulse and B/P were normal." . Patient recovered.

HPV (GARDASIL) Side Effects Report #355217
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: Pallor, "3 minutes after client received5 vaccinations she became diaphoretic, pale, nauseated, faint, this continued for about 15 minutes, kept for observation with comfort measures for 35 minutes" NoNo . During the same period patient was treated with No. 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: Pallor, "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 #355251
HPV (GARDASIL) vaccine side effect was reported on 08/19/2009. Female patient, child 12.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Pallor, "CNP present after incident. 1550- Became pale, lightheaded - became unresponsive immediately following injection . Assisted with lowering head to knees (pt was sitting in chair). Pulse present, resp shallow. After approx 10 sec, opened eyes agreed to being ok. 1600 - B/P 104/68 P-72 - R 28 . Didn't become clammy. Denies nausea 0/0 dizziness. ~Chest hurts - 1605 - BP 118/70 - 1610 HRT R 24 - Recalls little. 1630 Attempted to leave clinic with mother - very vague - c/o tight - numb throat Resp 28 - Began breathing in paper sack - feels better. 1640 - feels better O2 sat 99%. Left with mother. Instructed to go to ER if doesn't improve." NoNoNone . During the same period patient was treated with No. Patient recovered.

HPV (GARDASIL) Side Effects Report #355702
HPV (GARDASIL) vaccine side effect was reported on 08/27/2009. Female patient, 15.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Pallor, "APPROX. 20 SECONDS AFTER RECVING HPV VACCINE #2 & HEPA #1 CHILD REPORTED FEELING NAUSEA & DIZZINESS, BECAME PALE & BRADYCARDIC AT 45BPM. SYMPS APPROX 10 MIN . SUPINE, & ORAL FLUIDS." NO"EKG DONE , REPEAT HR=60,B/P 94/61, RR=18, 02 SAT=100%. ( PREV. HX OF DIZZINESS W/ EXERTION) REFERRED TO CARDIO FOR PROLONGED PR INTERVAL" . Patient recovered.

HPV (GARDASIL) Side Effects Report #355830
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: Pallor, "Information has been received from a physician and a licensed practical nurse concerning an 18 year old female who on 11-OCT-2006, 21-FEB-2007, 21-JUN-2007 and 18-AUG-2009 was vaccinated with her first, second, third and fourth dose of GARDASIL respectively (lot # are 653735/0688F, 655165/1425F, 657868/0523U and 661952/1129X respectively). Suspect vaccination included a second dose of VAQTA (inactive) (dose 2). Concomitant therapy included MENACTRA (lot#U2866AA) and ADACEL (lot # 3068AA). The nurse stated that she did not see the third dose of GARDASIL documented in the patient's vaccination chart. The nurse stated the patient was given the fourth dose of GARDASIL in error. On 18-AUG-2009, after the patient had received the vaccination she felt dizzy and had syncope. The patient had loss of consciousness for about 10 seconds. The patient regained consciousness. The patient was pale, blood pressure 110/70, Oxygen Saturation on room air 98%. Oxygen was administered, Oxygen Saturation increased to 100%. The patient was observed for 30 minutes with blood pressure 102/62. When the patient stood she felt dizzy. The ambulance was notified and the patient was taken to hospital. The patient was not admitted to the hospital. Per the physician the patient had a seizure after the fourth dose vaccination and was taken to the ER, subsequently the patient was fine. Upon internal review, the seizure was determined to be other important medical event. Additional information has been requested." Syncope"Blood pressure, 08/18/09, 110/7; Blood pressure, 08/18/09, 102/6; Arterial blood O2, 08/18/09, 98%; Arterial blood O2, 08/18/09, 100%" . Patient recovered.

HPV (GARDASIL) Side Effects Report #355848
HPV (GARDASIL) vaccine side effect was reported on 08/24/2009. Female patient, 18.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Pallor, "Second dose of GARDASIL given to left deltoid muscle along with PPD to forearm. About 5-10 min after shot, became pale fell forward, hit floor, 3 cm laceration to right eyebrow area. Total time she was unconscious was less than one minute." Gall bladder removed 5/09.History of anxiety. . During the same period patient was treated with PREVACID & PEPCID AC. Patient recovered.

HPV (GARDASIL) Side Effects Report #355906
HPV (GARDASIL) vaccine side effect was reported on 08/27/2009. Female patient, child 12.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Pallor, "Patient was given ADACEL first without incident pt was then given GARDASIL vaccine and immediately lost consciousness for 2-3 minutes, followed by a 15-20 min duration of pallor, nausea, light headedness. Had pt rest, cool compress to head, given juice and crackers." NoneNone . During the same period patient was treated with None. Patient recovered.

HPV (GARDASIL) Side Effects Report #356058
HPV (GARDASIL) vaccine side effect was reported on 08/31/2009. Female patient, 15.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Pallor, "Client became lightheaded, pale and lost consciousness for 30-60 seconds while sitting on the examination table. Client was layed flat for approx 5 minutes, juice was then given and client was told to wait an additional 10 minutes in the waiting room." NONENONE . During the same period patient was treated with NONE. Patient recovered.

HPV (GARDASIL) Side Effects Report #356448
HPV (GARDASIL) vaccine side effect was reported on 09/03/2009. Female patient, 16.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Pallor, "Patient claims that she felt lightheaded after standing for 10 mins and she had to be assisted with walking. She also claims that after feeling lightheaded and dizzy she sat down on cold floor at which point ~everything was black~ for approximately 10-20 mins. Patient never lost consciousness. People with patient noted that she was pale and lips greenish and was sweating profusely." HYPOTHYROIDISM . Patient recovered.

HPV (GARDASIL) Side Effects Report #356456
HPV (GARDASIL) vaccine side effect was reported on 09/03/2009. Female patient, child 11.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Pallor, "PT BECAME PALE, WEAK AND DIZZY AFTER ADMINISTERING HPV VACCINE. PT REPORTED FEELING COLD AFTER ADMINISTRATION. PT WAS SITTING AT TIME ON INNOCULATION." NONENONE . During the same period patient was treated with NONE. Patient recovered.

HPV (GARDASIL) Side Effects Report #356460
HPV (GARDASIL) vaccine side effect was reported on 09/03/2009. Female patient, 15.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Pallor, "PT BECAME PALE, WEAK AND DIZZY AFTER ADMINISTERING HPV VACCINE. PT WAS SITTING AT TIME ON INNOCULATION. PT REPORTED FEELING COLD AFTER ADMINISTRATION." NONENONE . During the same period patient was treated with NONE. Patient recovered.

HPV (GARDASIL) Side Effects Report #357402
HPV (GARDASIL) vaccine side effect was reported on 09/15/2009. Female patient, child 12.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Pallor, "Received 3rd dose HPV vaccine in office this am, then went to school and within 1 hour developed severe HA. Then complained could not see out of one eye and subsequently vomited. Has been having migraine like HA since school started. Pt pale on exam here but otherwise normal." NoneNoneExam; vision eval . During the same period patient was treated with MOTRIN. Patient recovered.

HPV (GARDASIL) Side Effects Report #357644
HPV (GARDASIL) vaccine side effect was reported on 07/27/2009. Female patient, 14.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Pallor, Within minutes of the administration of the vaccines pt became pale and felt lightheaded. She began c/o numbness in her hands with her hands feeling cold. I sat her on a chair with her head between her knees and had her breathe in a bag x 30 seconds. Soon after she began feeling better and her pallor started fading with resolution of numbness and lightheadedness. She left the office on her own accompanied by her mother. NoneNone . Patient recovered.

HPV (GARDASIL) Side Effects Report #357919
HPV (GARDASIL) vaccine side effect was reported on 08/19/2009. Female patient, 15.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Pallor, "Chest pain, trouble breathing, rapid heart beat, abdominal pain, numbness in leg, numbness in jaw, sweating, paleness, headaches, numbness in arm/hand, hives. 12/4/2009 PCP records for visits 5/2009-11/2009. Patient with c/o's headaches, eye pain, per patient went to ED 9/2009 with same c/o's and a neg w/up, no tx noted" PMH: None Allergies: NKDA"Labs: CBC, CMP, UA w/culture normal, abnormal pap smear Dx studies: MRI Head wnl" . Patient recovered.

HPV (GARDASIL) Side Effects Report #358049
HPV (GARDASIL) vaccine side effect was reported on 09/17/2009. Female patient, 18.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Pallor, "Pt became weal after receiving HPV injection and was assisted to supine position on examining table. Immediately reported feeling better. Recommended meningitis be with held today. Pt and mother stated pt. needs meningitis for college. Requested immunization today. Meningitis given. Pt then became weak and pale. No improvement. Pt became cold, clammy c/o abd. pain. 911 called. Pt declined stated going to her own private MD. Ambulated out of clinic assisted by her mother. Initial B/P 150/98 P 60 T 96.7 when paramedics arrived B/P 110/59 P 56." noneSeasonal allergies . Patient recovered.

HPV (GARDASIL) Side Effects Report #358295
HPV (GARDASIL) vaccine side effect was reported on 09/24/2009. Female patient, 16.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Pallor, "Immediately after receiving vaccinations, patient arched back, neck extended back and to the right, eyes fluttered and rolled back. Patient not responsive; not answering questions or talking. She was eased from the chair to the floor. Her body was stiff and jerking and had to be fully supported by 2 individuals. The jerking stopped within 2 minutes. Patient remained lethargic, eyes opened and then slowly closed repeatedly for the next ~15 minutes. Patient complained of upset stomach immediately following seizure-like activity, but denied needing to vomit. Skin was pale and moist. 10/7/09 ER records received for date 9/21/09. DC DX: seizure vs. syncope. Presenting sx: As pt was receiving vaccine, she arched her back, may have had loss of consciousness and/or seizure. Pt states in ER feeling fine. Assessment: PE WNL. ICD9 codes: 781.0, 780.39." None"Told by guardian/translator that patient had a history of seizures. She had not had any seizures since coming to the US in 2/09. She saw a doctor and had blood work done on 9/21, but was on no meds a time of vaccinations. 10/7/09 ER records received for date 9/21/09. PMH: 3 previous sycopal episodes in past 3-4 yrs."Patient transported by ambulance to PV ER. Testing done on blood (chemistries) and urine (UA and pregnancy test); all within normal limits other than slightly elevated Chloride level. No radiolgic testing done. Diagnosis was seizure vs. . During the same period patient was treated with None. Patient recovered.

HPV (GARDASIL) Side Effects Report #359336
HPV (GARDASIL) vaccine side effect was reported on 09/30/2009. Female patient, child 12.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Pallor, "GARDASIL first shot - immediately after receiving shot, patient turned grey. Within half an hour of receiving the shot, patient was dizzy, confused, light headed, severely nauseous, reported blurry vision, had gait dysfunction, appeared ~stoned~, and was unable to hold her head up straight. This continued throughout the day -shot was administered at 11:30am-. Primary doctor was contacted and indicated this was and adverse reaction to the GARDASIL shot. At approx 5pm - I -the patient's mother- decided it was time to to to the ER. Took patient to ER, diagnosis of adverse vaccine reaction was confirmed, manufacturer was contacted -merck-, and ER doctor confirmed with Merck that generally these reactions do not progress beyond the point where patient was in reaction. Patient was released after observation of vitals and neurological responses. 10/6/09 ER records received for 9/28/09. DC DX: Vaccine reaction, Dizziness, HA. Presenting SX: pt went to ER with c/o dizziness, headache, blurred vision after gardasil vaccine same day. Assessment: onset of dizziness 8 hours prior to ER, at time of ER visit sx improving. PE WNL." 10/6/09 ER records received for 9/28/09. lactose intolerant.10/6/09 ER records received for 9/28/09. Diagnostics/Labs: accucheck WNL. . Patient recovered.

HPV (GARDASIL) Side Effects Report #359491
HPV (GARDASIL) vaccine side effect was reported on 10/05/2009. Female patient, 18.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Pallor, She was standing and began to feel weak then fainted and was completely unconscious for a few minutes. She turned completely white her eyes rolled upward and she was moaning. She could not respond for a few minutes and was completely limp. No . Patient recovered.

HPV (GARDASIL) Side Effects Report #360387
HPV (GARDASIL) vaccine side effect was reported on 10/12/2009. Female patient, child 12.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Pallor, "Pt turned pale and said she felt ~sick~. She wanted to go get a drink I had her stay seated and she passed out. M.A. and I picked her up and laid her on the exam table. M.A. got M.D. and I stayed w/pt. We took her BP when she awoke 120/80. We let her lie for 15 min. She got up walk around and then discharged." None . During the same period patient was treated with None. Patient recovered.

HPV (GARDASIL) Side Effects Report #361663
HPV (GARDASIL) vaccine side effect was reported on 10/20/2009. Female patient, child 11.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Pallor, "The mother stated the child complained of feeling hot, became flushed and diaphoretic, and consequently vomited. After vomiting, the pt was pale. Blood pressure after incident 85/52 and BP 30 later was 98/58" no"asthma, allergic rhinits, ADD w/o hyperactivity" . During the same period patient was treated with Singulair 5mg chewable tab ventolin HFA Flonase. Patient recovered.

HPV (GARDASIL) Side Effects Report #361892
HPV (GARDASIL) vaccine side effect was reported on 10/20/2009. Female patient, child 11.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Pallor, "The patient complained of intense pain, became pale and appeared to have a near syncopal event. She then complained of nausea, felt she was going to vomit but did not and was afraid she was going to die. She was examined, all vitals were stable, and reassurance was provided. The patient felt better and left the office with no further complaint after approximately 30 minutes" NONOnone . Patient recovered.

HPV (GARDASIL) Side Effects Report #364100
HPV (GARDASIL) vaccine side effect was reported on 10/30/2009. Female patient, 13.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Pallor, "Immediately follow administration of 2nd vaccine(Hep A) child slumped forward with jerking motions of upper and lower extremeties for 3-5 seconds. Child then lifted head up with PHN asking child name and place. Child answered appropriately. She was pale, c/o being hot and feeling nauseated. PHN lay child on bed, applied cool cloth and fanned. Called Dr. Hensleigh's office and child carried to MD for evaluation. Child and child's mother returned to Clinic approximately 30 to 45 minutes later stating that Dr. Hensleigh evaluated and determined that this occurred due to child was very nervous and apprehensive before injections. No other problems occurred and child went to school the following day, 10/29/2009. PHN called to check on child again on 10/30/2009 with mother stating child having no further problems after leaving clinic the day vaccines given, 10/28/09." nonoMD visit for evaluation. . Patient recovered.

HPV (GARDASIL) Side Effects Report #364249
HPV (GARDASIL) vaccine side effect was reported on 10/27/2009. Female patient, child 12.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Pallor, "Pt was given Hep H #2 immunization an then got HPV #2 vaccine. At that point she became limp& pale. the nurse laid her down & called for her. She was doing fine when I checked into the room. The nurse said ~ it appeared she had a mini seizure that lasted approx 10-15 seconds. No treatment need. Sx showed spontaneously." NoneNKDA-Asthma without exacerbationNone . During the same period patient was treated with Albuterole HFA- Phenergan; Singular-Delsym-Nasal; Advair Diskus-Lohist D. Patient recovered.

HPV (GARDASIL) Side Effects Report #365578
HPV (GARDASIL) vaccine side effect was reported on 10/30/2009. Female patient, 15.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Pallor, "Patient slumped in chair, began seizure - like activity, became pale, then after I tried to get a response from her began crying and stated she was scared." . During the same period patient was treated with Depo-Provera. Patient recovered.

HPV (GARDASIL) Side Effects Report #366527
HPV (GARDASIL) vaccine side effect was reported on 11/10/2009. Female patient, child 11.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Pallor, "vaccine administered, patient left immunization room and was asked if she had any signs or symtoms related to vaccine replied ~No~ steped into hallway with family and started to feel faint. Patient was taken back to room elvated feet, Bp taken, given Juice and Crackers, patient facial skin was pale and sweating. She was not released to go home until all symptoms subsided and able to walk with out assistance." no illness at timenone . Patient recovered.

HPV (GARDASIL) Side Effects Report #367259
HPV (GARDASIL) vaccine side effect was reported on 11/13/2009. Female patient, child 12.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Pallor, BECAME PALE AND LIGHT HEADED WITHIN 10 MINUTES OF ADMINISTERING VACCINE. LAID DOWN ON FLOOR WITH COOL COMPRESS TO FOREHEAD. MOTHER PRESENT. NONEPENICILLIN AND SULFANA . During the same period patient was treated with NA. Patient recovered.

HPV (GARDASIL) Side Effects Report #367982
HPV (GARDASIL) vaccine side effect was reported on 11/17/2009. Female patient, 14.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Pallor, "Patient jerked backwards, went rigid and fell straight back on her head on a concrete carpeted floor. Patient lost conciousness for a few seconds, and regained orientation thereafter. She was given orange juice, and laid on her back. Paramedics were present and assessed her head injury and transported the patient to the nearby Hospital." NONE IdentifiedNONE Identified"Pt's blood pressure was low when assessed after reaction, and patient never gained full color after syncope." . Patient recovered.

HPV (GARDASIL) Side Effects Report #368053
HPV (GARDASIL) vaccine side effect was reported on 11/17/2009. Female patient, 13.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Pallor, "PT. Jerked back and fell on the back of her head and hit the floor. She was pale, LOC for several seconds and regained and was Alert and Oriented x3. Pt's BP was low, and concern for head injury, was sent to local hospital for further evaluation." NONE IdentifiedNONE Identified . Patient recovered.

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

HPV (GARDASIL) Side Effects Report #369193
HPV (GARDASIL) vaccine side effect was reported on 11/20/2009. Female patient, 18.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Pallor, "Following the administration of seasonal flumist, Gardasil, and PPD Mantoux test, patient became faint, pale, shaky, and incontinent. She did not lose consciousness or fall. Patient assisted to lie down with feet elevated, drink two juice boxes, cool rags placed on forehead and neck. Within 2 minutes, patient returned to normal color, and no longer was faint or dizzy. Paitient instructed to sit in chair and remain seated for 15 minutes prior to leaving clinic. Upon leaving clinic, patient continued to be free of dizziness or faintness, and kept normal coloring." NoneNoneNone . During the same period patient was treated with PPD Mantoux Test Sanofi Pasteur Lot # C3150AA Left Forearm. Any other medications or adverse events previously are unknown.. Patient recovered.

HPV (GARDASIL) Side Effects Report #370251
HPV (GARDASIL) vaccine side effect was reported on 11/11/2009. Female patient, 16.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Pallor, "Syncopal episode after Gardasil #1 (pale, clammy, slid to floor?, hit head-easily aroused B/P 105/55 pulse 70). Within 5 min, assisted to chair, sipping soda, lying on fathers shoulder became faint again.... Assisted to exam room/ within 20 min able to sit without dizziness or complaints. Home with father. No complaints best day when follow up call made." None"Hx: ~childhood asthma~"None . During the same period patient was treated with None. Patient recovered.

HPV (GARDASIL) Side Effects Report #372259
HPV (GARDASIL) vaccine side effect was reported on 11/27/2009. Female patient, 19.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Pallor, "My daughter was a freshman (2006) in college when she fainted outside in the snow on campus in the month of January. She was taken to the student health center, then the hospital and released. She was mistakenly diagnosed with anxiety. The college nurse contacted me and insisted that something else was very wrong because my daughter's oxygen level was below normal. Upon the nurse's urging, I took my daughter to a pulmonologist. She was given a chest scan. I was told to admit her to the hospital immediately due to multiple pulmonary embolisms in her lungs. She was hospitalized for 5-7 days. She was then under the care of a hematologist who diagnosed her with an auto-immune disorder called anti-phospholipid antibody syndrome. Neither side of the family has any type of auto-immune disorder. Three years later she continues to take a blood thinner. We do not know how long she was functioning with the clots in her lungs before the fainting incident. I believe that the college nurse saved her life. This past August on the news, it was mentioned that GARDASIL has been found to cause fainting, clotting and auto immune disorders. I was suspicious that the vaccine caused this disorder in my daughter so when I heard the news report, my fears were confirmed. This clotting diagnosis occurred within 6 months of the time frame that she had the 2 of 3 recommended series of this vaccine. (The first dosage was in August. The second dosage was given in November). The manufacturer of this vaccine continues to aggressively market this product despite the problems associated with it." noneNone 12/10/09 PMH: NKDAHematologist has tests indicating auto-immune disorder. Pulmonologist has report indicating pulmonary embolism. 12/10/09 Diagnostic tests: Pulse OX-88-91%. 12/15/09 Diagnostic tests: CT scan chest- mult. large pulmonary emboli in central . Patient was hospitalized Patient recovered.

HPV (GARDASIL) Side Effects Report #372072
HPV (GARDASIL) vaccine side effect was reported on 12/03/2009. Female patient, 20.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Pallor, "Patient given above injection in left deltoid, then GARDASIL in right deltoid, was talking to nurse while sitting on exam table. (Approx 3 min after vaccine given). Patient fell back against wall, then flapped to side on exam table. Nurse moved forward, swung legs onto table and placed on side. Noted pallar, diaphoresis. Responsive after 30 sec. Placed supine, feet elevated, given iced tea recovered well over few minutes." NoneNone . During the same period patient was treated with Loestrin. Patient recovered.

HPV (GARDASIL) Side Effects Report #373610
HPV (GARDASIL) vaccine side effect was reported on 12/10/2009. Female patient, child 11.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Pallor, "Patient received ADARIEL, GARDASIL, and MENACTRA on 12/8. Shortly after became nauseated and pal. Rested and took juice-felt better. On 12/10 parent called- patient feel her arms and legs feel ~gooey~. Had fever on 12/9. Achy muscles-not free weakness. Also has persistent nausea." Mild URI . Patient recovered.

HPV (GARDASIL) Side Effects Report #374996
HPV (GARDASIL) vaccine side effect was reported on 12/26/2009. Female patient, child 11.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Pallor, "After first Gardasil vaccine, my daughter became pale, dizzy, and fainted while trying to walk. Had to be carried by nurse and myself (Mom) and returned to exam room to lie down." NoNo . During the same period patient was treated with None. Patient recovered.

HPV (GARDASIL) Side Effects Report #375408
HPV (GARDASIL) vaccine side effect was reported on 12/29/2009. Female patient, 17.0 years of age, was vaccinated with HPV (GARDASIL). Patient symptoms: Pallor, Patient after having shot felt dizzy and nausea afterwards. She passed out in waiting room. She was brought back and laid down on bed. Blood pressure at that time 55/35 and pulse was 35. She was confused and stuperous. Patients color was very pale but eventually returned to pink after several mins and back to normal color after about 6-7 mins. Blood pressure increased to 88/55 and pulse was up to 70. After 20 mins of patient laying down she was able to sit up and carry on conversations as well as walk without difficulty. This was patients 2nd HPV and advised to not have 3rd HPV due to the reaction. noneAsthma and Acne . During the same period patient was treated with BenzaClin 1%/5% Topical Gel Flovent 110mcg Oral Inhaler. Patient recovered.


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