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Found 6884 cases where Vaccine is HPV4 and Serious

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VAERS ID: 275251 (history)  
Form: Version 1.0  
Age: 17.0  
Sex: Female  
Location: California  
Vaccinated:2007-03-15
Onset:2007-03-15
   Days after vaccination:0
Submitted: 2007-03-29
   Days after onset:14
Entered: 2007-03-30
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0011U / 1 - / IM

Administered by: Other       Purchased by: Other
Symptoms: Activities of daily living impaired, Muscle twitching, Musculoskeletal stiffness, Pain in extremity
SMQs:, Dementia (broad), Dyskinesia (broad), Dystonia (broad), Parkinson-like events (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown. 7/7/2009 Neuro consult received. (+) PPD age 5. OCs.
Allergies:
Diagnostic Lab Data: Unknown. 7/7/2009 Neuro consult received. Labs and Diagnostics: EEG abnormal. MRI brain WNL.
CDC Split Type: WAES0703USA03961

Write-up: Initial and follow-up information has been received from a Medical Assistant concerning a 17 year old female patient who on 15-MAR-2007 was vaccinated IM with her first dose of Gardasil, lot #654702/0011U. The reporter reported soon after the injection "her arm hurt really bad" and was stiff. On 16-MAR-2007 the patient developed sporadic twitching of her whole body. The reporter stated that the patient "looked as if she had Tourette syndrome. " On 17-MAR-2007 the patient was examined in the emergency room and was released a few hours later. She was examined by her primary physician and gynecologist. She had an appointment with a neurologist. She has not had any improvement in her symptoms of sporadic twitching, however arm pain and stiffness were subsiding. The reporter considered the events to be disabling because the patient was unable to perform her activities of daily living for a week. Additional information has been requested. 7/7/2009 Neuro consult received for 3/20/07-4/13/07 with DX: Intermittent myoclonus. Pt presented for consult after developing twitching in the L leg and shoulder which developed on 3/16/07, one day after receiving HPV vax in R deltoid. Pt also c/o shoulder pain and RUE pain making it difficult to use the R arm. Pt c/o increasing frontal H/A since that time as well. Plantar responses were flexor on the right and extensor on the left. Intermittent jerky movement mostly upper part of body toward left shoulder and rarely in the legs. F/U 3/30/07 with continued H/A and blurred vision but improvement in twitching. RUE pain improved, but now sharp pain in top of neck. Tx with Naproxen which was later d/c due to epigastric pain. Topamax started. 7/14/09 PCP records recd. Seen 3/19/07 for dx: motor twitching. See neuro records. 7/17/09 ER records received DOS 3/17/07 to 3/18/07. Assessment: Shoulder Twitching. Patient presented with sudden onset left shoulder twitching (intermittent). Left shoulder muscle pain. Ativan prescribed, symptom improved, and patient discharged.


VAERS ID: 275365 (history)  
Form: Version 1.0  
Age: 18.0  
Sex: Female  
Location: Unknown  
Vaccinated:2007-01-15
Onset:2007-01-15
   Days after vaccination:0
Submitted: 2007-03-30
   Days after onset:73
Entered: 2007-04-02
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 1427F / 1 UN / IM

Administered by: Private       Purchased by: Other
Symptoms: Hypokinesia, Pain in extremity, X-ray normal
SMQs:, Parkinson-like events (broad), Guillain-Barre syndrome (broad), Hypotonic-hyporesponsive episode (broad), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: hormonal contraceptives
Current Illness: Penicillin allergy
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: joint X-ray 01/15/07 negat
CDC Split Type: WAES0703USA03948

Write-up: Information has been received from a physician concerning an 18 year old female with AMOXIL allergy who on 15-JAN-2007 was vaccinated with the first dose of Gardasil (lot #655619/1427F), IM, 0.5 ml. Concomitant therapy included hormonal contraceptives (unspecified). On 15-JAN-2007, the patient experienced prolonged left arm pain and limitation of movement secondary to arm pain following the first dose of Gardasil. No redness or swelling was noted. A shoulder x-ray was negative. The patient was treated with an unspecified NSAID''s (non-steroidal, anti-inflammatory drug) and was referred to a neurologist. At the time of the report, the patient''s prolonged left arm pain persisted and was considered to be disabling. Additional information has been requested.


VAERS ID: 275366 (history)  
Form: Version 1.0  
Age: 26.0  
Sex: Female  
Location: Massachusetts  
Vaccinated:2007-03-05
Onset:2007-03-05
   Days after vaccination:0
Submitted: 2007-03-30
   Days after onset:24
Entered: 2007-04-02
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0186U / UNK LA / IM

Administered by: Other       Purchased by: Other
Symptoms: Discomfort, Hypokinesia, Injected limb mobility decreased, Injection site pain
SMQs:, Parkinson-like events (broad), Guillain-Barre syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Hypotonic-hyporesponsive episode (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: hormonal contraceptives
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0703USA03899

Write-up: Information has been received from an RN concerning a 26 year old female patient who on 05-MAR-2007 was vaccinated IM in left deltoid with a dose of Gardasil, lot #655618/0186U. Concomitant therapy included unspecified birth control pills. The nurse indicated that the patient has experienced soreness at the injection site from the dose of Gardasil since 05-MAR-2007, and described the symptoms as "uncomfortable". The patient is a dancer and cannot lift her arm. Medical attention was sought and Advil was taken for the symptoms. The patient''s symptoms have improved but they have not resolved. The nurse felt that the patient''s symptoms were disabling because she was unable yo work as a dance instructor and cannot keep her arm up over her head. Additional information has been requested.


VAERS ID: 275428 (history)  
Form: Version 1.0  
Age: 12.0  
Sex: Female  
Location: New York  
Vaccinated:2007-03-01
Onset:2007-03-07
   Days after vaccination:6
Submitted: 2007-04-02
   Days after onset:25
Entered: 2007-04-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEPA: HEP A (VAQTA) / MERCK & CO. INC. 1280F / 2 RA / IM
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0263U / 1 LA / IM
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. 0943R / 2 RA / SC

Administered by: Unknown       Purchased by: Unknown
Symptoms: Autopsy, Myocarditis, Ventricular tachycardia
SMQs:, Torsade de pointes/QT prolongation (narrow), Ventricular tachyarrhythmias (narrow), Torsade de pointes, shock-associated conditions (narrow), Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2007-03-08
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: none
Preexisting Conditions: aortic and mitral valve insufficiency, unknown aetiology
Allergies:
Diagnostic Lab Data: ER LABS of 3/8/07: ABG pH 7.23, po2 62. Serum glucose 353, Creat 1.7, albumin 2.6, total protein 4.9, SGPT 62, SGOT 359. Blood c/s was neg. 2005 Cardiology LABS: echocardiogram revealed mild mitral valve & aortic valve insufficiency. Mitral valve leaflets were slightly thickened.
CDC Split Type:

Write-up: presented to ED with Ventricular tachycardia. Preliminary autopsy finding of myocarditis. 4/3/07 Spoke w/ME who stated prelim COD as acute myocarditis, presumably viral. States patient had PMH of heart murmur which was evaluated by ped cardiologist who found mild aortic & mitral valve insufficiency & regurgitation. ME states did not see evidence of that on autopsy but did find cardiomegaly. Also states patient had been taken to ER on day of death for abdominal pain w/fever & was dx w/gastroenteritis. CXR at that time revealed cardiomegaly. No EKG or cultures were done. Was d/c to home & continued to not feel well. Parent found patient in bathroom unresponsive at approx 2AM & was transported to a second ER where she expired. ME states patient had approx 2 week hx of cough & runny nose prior to death. 6/12/07 Received final Autopsy Report which reveals COD as acute probable viral etiology myocarditis & manner of death as natural. 6/29/07 Received ER records from hospital where patient expired which reveal patient was in respiratory arrest & had been intubated by EMS. ACLS measures were unsuccessful & patient pronounced. 8/24/07 Received cardiology consult which reveals patient evaluated for heart murmur in 2005 which had been diagnosed for long time but never evaluated. Patient admitted to palpitations & nervousness. Patient history did not reveal any evidence of rheumatic fever. Antibiotic endocarditis prophylaxis recommended prior to dental & surgical procedures. Patient was to f/u w/cardiology in 2-3 yearrs to document progress of valvular insufficiency. FINAL Cardiology DX: Aortic & mitral valve insufficiency of unknown etiology.


VAERS ID: 275438 (history)  
Form: Version 1.0  
Age: 19.0  
Sex: Female  
Location: California  
Vaccinated:2007-03-12
Onset:2007-03-26
   Days after vaccination:14
Submitted: 2007-04-02
   Days after onset:7
Entered: 2007-04-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0263U / 1 LA / IM

Administered by: Other       Purchased by: Other
Symptoms: Convulsion, Echocardiogram abnormal
SMQs:, Systemic lupus erythematosus (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2007-03-26
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Yasmin birth control pills; hormal contraceptives
Current Illness: None
Preexisting Conditions: None PMH: contraception; Non-smoker
Allergies:
Diagnostic Lab Data: echocardiogram, 03/26?/07, very enlarged right ventricle and small left ventricle as well as large blood clots (see narrative)
CDC Split Type: WAES0705USA05011

Write-up: Given Gardasil vaccine dose #1 3/12/07. No adverse reaction reported. Collapsed and died on 3/26/07 secondary emboli (records unavailable). 4/3/07 Spoke w/investigating deputy who stated autopsy done at Medical Center. T/C to physician at Medical Center who is actually a cardiologist, not pathologist, who had responded to the code & pronounced. Spoke w/secretary who states from Death Certificate COD is sudden cardiac death and pulmonary embolism. Echocardiogram revealed very enlarged right ventricle & small left ventricle as well as large blood clots within both the right atrium & right ventricle. 6/25/07 Received Autopsy Report which reveals following anatomic diagnosis: 1. Pulmonary embolism, occlusive a. pulmonary trunk, left hilar & peripheral vessels b. acute cor pulmonale (by echocardiogram) 2. Pulmonary congestion & edema, bilatera a. no evidence of anomalous coronary artery distribution b. no evidence of ventricular dysplasia This is in follow-up to report(s) previously submitted on 6/11/2007. Information has been received on request from the FDA under the Freedom of Information Act and from a physician who presented at the "Global Advisory Committee on Vaccine Safety World Health Organizaqtion" concerning a 19 year female nonsmoker with no history who on 12-MAR-2007 was vaccinated IM into the left arm with a first dose of GARDASIL lot #655849/0263U). Concomitant therapy included oral contraceptives. There was no adverse reaction reported. Subsequently on 26-MAR-2007 the patient, while exercising on a field collapsed, began convulsing and died secondary to emboli. An autopsy was done and on the death certificate the following is documented "sudden cardiac death and pulmonary embolisem." An Echocardiogram revealed a very enlarged right ventricle and small left ventricle as well as large blood clots within both the right atrium and right ventricle. Coronary artery thrombosis and thrombosis were alsor reported. Upon internal review convulsing was considered an other important medical event. The original reporting source was not provided. A standar lot check investigation was performed. All in-process quality checks for the lot number in question were satisfactory. In addition, an expaned lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. No further information is available. This report was filed with the FDA. The VAERS number is 275438.


VAERS ID: 275584 (history)  
Form: Version 1.0  
Age: 16.0  
Sex: Female  
Location: Unknown  
Vaccinated:2007-03-01
Onset:2007-03-01
   Days after vaccination:0
Submitted: 2007-04-03
   Days after onset:32
Entered: 2007-04-04
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Chest discomfort, Dyspnoea, Erythema, Injection site pain, Injection site swelling, Oxygen supplementation
SMQs:, Anaphylactic reaction (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Hypersensitivity (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0703USA05676

Write-up: Information has been received from a registered nurse (a school nurse), via a company representative, concerning a 16 year old female patient, who in March 2007, was vaccinated with a dose, 0.5ml, IM, of Gardasil. The nurse reported that on the following day, the patient developed swelling and pain at the injection site, chest tightness, shortness of breath and facial redness, and was transported by ambulance to the emergency room. The nurse stated that treatment included oxygen, and epinephrine injection, and prednisone. Following treatment "the patient''s symptoms resolved and the patient completely recovered." The nurse considered the events to be life threatening and disabling. Additional information has been requested.


VAERS ID: 275631 (history)  
Form: Version 1.0  
Age: 13.0  
Sex: Female  
Location: Pennsylvania  
Vaccinated:2006-12-18
Onset:0000-00-00
Submitted: 2007-04-04
Entered: 2007-04-05
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 1 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Arthralgia, Dizziness, Headache, Laboratory test, Loss of consciousness, Vision blurred
SMQs:, Torsade de pointes/QT prolongation (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Glaucoma (broad), Lens disorders (broad), Retinal disorders (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Arthritis (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: diagnostic laboratory - results not reported
CDC Split Type: WAES0703USA05511

Write-up: Information has been received from a physician concerning a 13 year old female who on 18-DEC-2006 was vaccinated with a first dose of Gardasil (lot #654389/0961F). There was no concomitant medication. Subsequently, the patient experienced hip, knee and ankle pain. In January 2007, the patient began to experience occasional episodes of blurry vision. On 02-FEB-2007, the patient was vaccinated with a second dose of Gardasil. It was reported that the patient''s symptoms "severely worsened" following the second dose of Gardasil and the patient also experienced lightheadedness and increase in headaches. The patient was seen by an orthopedic physician on 02-FEB-2007. Unspecified laboratory and diagnostic tests were performed (results not reported). On 07-FEB-2007 the patient experienced "one episode of blacking out." The patient saw a neurologist on 20-MAR-2007. At the time of the report, the patient had not recovered. The reporting physician considered the events to be disabling as the patient was unable to participate in ballet or dancing classes. Additional information has been requested.


VAERS ID: 275703 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Unknown  
Vaccinated:2007-03-26
Onset:0000-00-00
Submitted: 2007-04-05
Entered: 2007-04-06
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / -

Administered by: Other       Purchased by: Other
Symptoms: Abdominal pain, Laboratory test normal
SMQs:, Acute pancreatitis (broad), Retroperitoneal fibrosis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: diagnostic laboratory - normal
CDC Split Type: WAES0703USA05647

Write-up: Information has been received from a pharmacist (PharmD) concerning a female (age unknown) patient who on 26-MAR-2007 was vaccinated with a dose of Gardasil which was thought by the reporter to be her initial dose. Subsequently, on an unspecified date, the patient experienced generalized abdominal pain and was hospitalized on 29-MAR-2007 to rule out appendicitis. The pharmacist stated that all of the patient''s test have come back normal but could not identify specifically what tests or labs were performed. It was noted that the patient was treated with IV fluids and pain medication as needed. At the time of this report, the patient had not recovered. No product quality complaint was involved. The reporter considered generalized abdominal pain to be an other important medical event. Additional information has been requested.


VAERS ID: 275712 (history)  
Form: Version 1.0  
Age: 13.0  
Sex: Female  
Location: Florida  
Vaccinated:2007-04-03
Onset:2007-04-03
   Days after vaccination:0
Submitted: 2007-04-06
   Days after onset:3
Entered: 2007-04-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0188U / 1 LA / IM
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA) / SANOFI PASTEUR U226AA / 1 RA / IM

Administered by: Private       Purchased by: Private
Symptoms: Computerised tomogram abnormal, Fall, Head injury, Headache, Neck pain, Subarachnoid haemorrhage, Syncope, Unresponsive to stimuli
SMQs:, Torsade de pointes/QT prolongation (broad), Haemorrhage terms (excl laboratory terms) (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Haemorrhagic central nervous system vascular conditions (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Arthritis (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: none
Preexisting Conditions: Allergic to penicillin ALLERGIES: PCN, urticaria. PMH: fainting episodes, mild concussion 3-5 mos ago from sports injury. Pounding headaches 1-3 x/week. Family hx of headaches.
Allergies:
Diagnostic Lab Data: LABS: CT at transfer hospital revealed hemorrhagic focus within medial left frontal high convexity adjacent to falx w/subdural hematoma along the falx. WBC 19.8. CT angiography was WNL. EEG was reported as neg but no report provided.
CDC Split Type:

Write-up: Fainted within 10 min of receiving vaccines and fell backward and hit head on carpeted floor was unresponsive for 20-30 seconds. Complained of headache and neck pain. Transported to ER - CT showed traumatic subarachnoid hemorrhage. Transferred to PICU. 5/11/07 Received medical records from hospital which reveal patient experienced syncopal episode & fell backward w/o bracing herself, striking posterior head & becoming dazed & minimally responsive for several minutes. Seen at outlying hospital & had CT scan which revealed SAH & skull fx. Exam revealed alert & oriented, hematomas over skull. Tx w/dilantin. Neurosurg & neurology consults done. Seizure was ruled out & dilantin d/c. Strong suspicion for vascular abnormality due to amount of intracranial bleeding after fall. FINAL DX: traumatic subarachnoid hematoma.


VAERS ID: 275899 (history)  
Form: Version 1.0  
Age: 15.0  
Sex: Female  
Location: Pennsylvania  
Vaccinated:2007-03-12
Onset:2007-03-19
   Days after vaccination:7
Submitted: 2007-04-09
   Days after onset:21
Entered: 2007-04-10
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0961F / 1 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Feeding disorder, Movement disorder, Tic
SMQs:, Akathisia (broad), Dyskinesia (broad), Dystonia (broad), Parkinson-like events (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: (therapy unspecified), fentanyl, TOPAMAX
Current Illness: Turner''s syndrome; Migraine; Hypertelorism
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0704USA00353

Write-up: Information has been received from a physician concerning a 15 year old female patient with Opitz syndrome (hypertelorism-hypospadias), Turner''s syndrome and migraines who was on 12-MAR-2007 vaccinated with a first dose of Gardasil, lot #654389/0961F (dose not reported). Concomitant therapy included TOPAMAX, fentanyl and other "unknown medications". On 19-MAR-2007 the patient developed a movement disorder characterized by "verbal and bodily" tics. On 20-MAR-2007 patient was hospitalized and treated with IV fluids. Unspecified laboratory tests were normal. She was seen by a neurologist who felt her tics were volitional because she could stop them when asked. Another neurologist felt the tics were not volitional because they occurred in her sleep. At the time of this report, the patient had not recovered. The physician considered the events to be disabling since she was unable to feed herself. Additional information has been requested.


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