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Found 6,988 cases where Vaccine is HPV4 and Serious

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VAERS ID: 303189 (history)  
Form: Version 1.0  
Age: 17.0  
Sex: Female  
Location: Florida  
Vaccinated:2008-01-06
Onset:2008-01-08
   Days after vaccination:2
Submitted: 2008-01-18
   Days after onset:10
Entered: 2008-01-22
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0515U / 3 LA / IM

Administered by: Other       Purchased by: Private
Symptoms: Activities of daily living impaired, Alanine aminotransferase normal, Albumin globulin ratio normal, Anorexia, Aspartate aminotransferase normal, Blood albumin decreased, Blood albumin normal, Blood alkaline phosphatase normal, Blood bilirubin normal, Blood calcium normal, Blood chloride normal, Blood creatinine normal, Blood glucose normal, Blood potassium normal, Blood sodium normal, Blood urea nitrogen/creatinine ratio, Blood urea normal, Carbon dioxide normal, Chills, Diarrhoea, Epstein-Barr virus antibody negative, Fatigue, Full blood count normal, Haematocrit normal, Haemoglobin normal, Headache, Hysterectomy, Insomnia, Laboratory test, Laboratory test normal, Mean cell volume normal, Mean platelet volume normal, Myalgia, Nausea, Pharyngolaryngeal pain, Platelet count normal, Protein total normal, Pyrexia, Red blood cell count normal, Vomiting, White blood cell count normal
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Pseudomembranous colitis (broad), Malignancy related therapeutic and diagnostic procedures (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Uterine and fallopian tube tumours of unspecified malignancy (broad), Noninfectious diarrhoea (narrow), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
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: PROZAC; vitamins (unspecified)
Current Illness: Anxiety
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data: complete blood cell - normal; diagnostic laboratory SMA - normal: monospot - negative; Epstein-Barr virus, normal; serum glucose, 01/10/08, 106; serum creatinine, 01/10/08, 0.83 mg/dl; serum sodium, 01/10/08, 139 mmol/; serum chloride, 01/10/08, 102 mmol/; serum calcium, 01/10/08, 9.1 mmol/; serum albumin, 01/10/08, 4.3 g/dL; white blood cell, 01/10/08, 5.0; LY- 17.9; MO 11.3; CR 70.8; LY 0.9; MO 0.6; WBC count, 01/10/08, 5.0; serum Epstein-Barr virus, 01/10/08, negative; serum alanine, 01/10/08, 14 U/L; serum aspartate, 01/10/08, 16 U/L; serum alkaline, 01/10/08, 76 U/L; total serum bilirubin, 01/10/08, 0.6mg/dL; serum albumin/globulin, 01/10/08, 1.6; serum globulin test, 01/10/08, 01/10/08, 2.7 g/dL; mean platelet volume, 01/10/08, 8.4 fl; platelet count, 01/10/08, 141; RDW, 01/10/08, 12.3%; mean corpuscular, 01/10/08, 33.4 g/dL; mean corpuscular, 01/10/08, 30.9 pg; mean corpuscular volume, 01/10/08, 92.6 fL; hematocrit, 01/10/08, 41.5; hemoglobin, 01/10/08, 23.9; red blood cell count, 01/10/08, 4.48; white blood cell, 01/10/08, 9.0; total serum protein, 01/10/08, 7.0 g/dL; total serum carbon, 01/10/08, 23 mmol/; serum potassium, 01/10/08, 4.3 mmol; serum BUN/creatinine, 01/10/08, 14; serum blood urea, 01/10/08, 12 mg/dl; hepatic function tests, normal; blood chemistry, normal
CDC Split Type: WAES0801USA02310

Write-up: Information has been received from a physician concerning her 17 year old daughter who on 06-JUL-2007, was vaccinated IM with a first 0.5ml dose of Gardasil. On 12-SEP-2007 and 06-JAN-2008, the patient was vaccinated with a second and third dose of Gardasil (Lot# 657872/0515U), respectively. Concomitant therapy included PROZAC and vitamins (unspecified). On 08-JAN-2008 two days later, the patient experienced nausea. On 09-JAN-2008 the next morning, she vomited. On approximately (09-JAN-2008 )since the last vaccination), she experienced myalgia, headache, sore throat, fever, loss of appetite and difficulty sleeping. Unspecified medical attention was sought. Laboratory diagnostic studies included a complete blood cell count which was reported as normal. As of 10-JAN-2008, the patient no longer had a fever or sore throat but she was experiencing an increase in her myalgia. As of 14-JAN-2008, it was reported that the patient started to feel better. It was also reported that the patient had not been able to attend school since 08-JAN-2008. On 15-JAN-2008, the patient returned to school. No product quality complaint was involved. Nausea, vomited, myalgia, headache, sore throat, fever, loss of appetite and difficulty sleeping were considered to be disabling by the reporter. Additional information is not expected. This is in follow-up to report(s) previously submitted on 1/18/2008; 1/25/2008. Information has been received from a physician concerning her 17 year old daughter with anxiety who on 06-JAN-2007 at 6:00 pm, was vaccinated IM into her left deltoid with a third dose dose of GARDASIL (Lot# 657872/0515U). On 08-JAN-2008, the patient experienced nausea for 4 days and she vomited three times. She also experienced myalgia, a severe headache for 1 week, a mild sore throat for 3 days, loss of appetite for 1 week, diarrhea for 2 days, prolonged sleeping and fatigue for 1 week. On 12-JAN-2008, the patient experienced a fever of 101.8F with rigors just before spike then she had a fever off and on for another day. Unspecified medical attention was sought. Laboratory diagnostic studies included monospot test, liver function tests and a blood chemistry panel which were all reported as normal. On 15-JAN-2008, the patient returned to school and recovered. It was also reported that on 06-JUL-2007, the patient was vaccinated IM with a 0.5ml dose of GARDASIL and on 12-SEP-2007 she was vaccinated with a second dose of the vaccine (Lot# 657872/0515U). Additional information is not expected.


VAERS ID: 303199 (history)  
Form: Version 1.0  
Age: 12.0  
Sex: Female  
Location: Ohio  
Vaccinated:2007-07-10
Onset:2007-07-10
   Days after vaccination:0
Submitted: 2008-01-17
   Days after onset:191
Entered: 2008-01-22
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0802U / 1 RA / UN
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA) / SANOFI PASTEUR U2224AA / 1 RA / UN
TDAP: TDAP (BOOSTRIX) / GLAXOSMITHKLINE BIOLOGICALS AC52B018AB / 1 LA / UN
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. 0715U / 2 LA / UN

Administered by: Private       Purchased by: Private
Symptoms: Computerised tomogram, Feeling abnormal, Head injury, Loss of consciousness, Vomiting
SMQs:, Torsade de pointes/QT prolongation (broad), Acute pancreatitis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 1 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: Allergy to Amoxil, Left anomolous carotoid Artery in middle ear. 2/4/08-records received-Allergy:Penicillin.
Allergies:
Diagnostic Lab Data: Head Ct 2/4/08-records received-CT scan left front contusion. Subsequent CT scan 7/37/07-resolution of left frontal parenchymal contusion. Normal CT.
CDC Split Type:

Write-up: Received vaccines, passed out while checking out and hit head on floor about 15 minutes later. Ice applied and observed x 20min. Did have brief LOC immediately after fall. Released to home, where began to experience episodes of vomiting and seemed "out of it" per dad about 1 1/2 after vaccine given. Sent per squad to MC-ER. Was evaluated and admitted. 2/4/08-records received for DOS 7/10-7/11/07-DC DX: Left frontal contusions secondary to fall. Experienced a vasovagal event after receiving vaccinations producing a fall to floor. Momentary loss of consciousness then recurrent emesis and confusion. C/O headache and waning nausea. Left-sided neck pain.


VAERS ID: 303475 (history)  
Form: Version 1.0  
Age: 18.0  
Sex: Female  
Location: New Jersey  
Vaccinated:2007-07-25
Onset:2007-12-17
   Days after vaccination:145
Submitted: 2008-01-23
   Days after onset:37
Entered: 2008-01-24
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0525U / 1 LA / UN
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA) / SANOFI PASTEUR U2380BA / 1 RA / -

Administered by: Other       Purchased by: Other
Symptoms: Areflexia, Guillain-Barre syndrome, IIIrd nerve paresis, Miller Fisher syndrome
SMQs:, Peripheral neuropathy (narrow), Guillain-Barre syndrome (narrow), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Demyelination (narrow), Ocular motility disorders (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, 3 days
   Extended hospital stay? Yes
Previous Vaccinations:
Other Medications: hormonal contraceptives
Current Illness:
Preexisting Conditions: Bell''s palsy PMH: left side Bell''s palsy in infancy
Allergies:
Diagnostic Lab Data: Unknown LABS: CBC, ESR & chemistry WNL. B. burgdorderi abnormal but not indicative of Lyme dx. EMG/NCS done which revealed early demyelinating process involving left ulnar nerve.
CDC Split Type: WAES0801USA03098

Write-up: Initial and follow up information has been received from a registered nurse, concerning a 19 year old female patient with a history of left sided Bell''s palsy (year unknown), who on 25-JUL-2007 was vaccinated with the first dose of Gardasil (lot # 658100/0525U). Concomitant therapy included birth control pills (unspecified manufacturer). On approximately 17-DEC-2007, the patient "developed symptoms" and on 31-DEC-2007 she was hospitalized with "probable Miller-Fisher variant of Guillain Barre syndrome." Her symptoms included ophthalmoparesis and areflexia with stocking-glove distribution. Treatment included immunoglobulin, IgG. On 01-JAN-2008 (previously reported as 07-JAN-2008), the patient was discharged from the hospital. The nurse indicated the patient had a follow up visit scheduled with a neurologist on 07-JAN-2008, though she had no knowledge of the results or findings from the visit. The nurse mentioned that the patient had not received subsequent doses of Gardasil, due to concern about the administration of IgG while in the hospital. At the time of this report, the outcome of the event was unknown. Additional information has been requested. 1/25/08 Follow up initiated at request of CDC. 1/25/08 Received vax record which reveals patient received Menactra U2380BA & Gardisil 0525U on 7/25/07. Admitted to hospital 12/31/07 after outpatient vs to neurologist. Numbness & tingling in hand started approx 2 wks prior & spread to left arm. Developed difficulty focusing, eye pain & numbness in both feet. Exam revealed ophthalmoparesis, areflexia & stocking/glove sensory disturbance. MRI of brain reviewed which was WNL. Nerve conduction studies done which was abnormal. Neuro hospital admit dx: probable Miller Fisher variant of Guillain-Barre syndrome. 2/5/08 Reviewed hospital medical records which reveal patient experienced numbness & tingling of hand & feet, difficulty focusing & eye pain starting approx 12/16/2007. On admit had limited extraocular movements w/left lateral gaze nystagmus, dysmetria on finger-to-nose on left & unsteady gait. Admitted 12/31/07-1/2/2008. Tx w/IVIG x 3 days w/noted improvement. Developed HA w/IVIG tx. D/C to home & f/u w/neurologist. FINAL DX: Miller-Fisher variant Guillain-Barre syndrome. 2/8/08 Reviewed neurologist med records which reveal patient seen 12/31/07. Pt had 2 wk hx of progressive numbness & paresthesias in bilat hand/feet which started w/left hand, as well as difficulty w/eye movements. F/U visit 1/7/08 revealed pt had HA, left eye shaking, numbness/tingling of hand/feet improving but still present. FINAL Neuro DX: probable Miller Fisher variant of Guillain-Barre syndrome.


VAERS ID: 303836 (history)  
Form: Version 1.0  
Age: 14.0  
Sex: Female  
Location: Missouri  
Vaccinated:2008-01-02
Onset:2008-01-03
   Days after vaccination:1
Submitted: 2008-01-28
   Days after onset:25
Entered: 2008-01-29
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEPA: HEP A (HAVRIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / UN
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 1448U / 1 UN / UN
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. 1658U / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Blood urine present, Chest pain, Chills, Flank pain, Micturition urgency, Nausea, Pollakiuria, Urine analysis abnormal, Weight decreased
SMQs:, Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhage laboratory terms (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Retroperitoneal fibrosis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 5 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: None. PMH: tonsillectomy, tendon repair R foot.
Allergies:
Diagnostic Lab Data: urinalysis 01/03/08 - trace of blood in urine. Labs and Diagnostics: UA with trace leukocytes, (+) nitrites, trace ketones, 1+ bilirubin, 4.0 urobilinogen, 1-3 WBCs, 2-5 epis. Repeat UA WNL 3 days later. UC (-)x2. CBC WNL. CMP unremarkable. Amylase and Lipase WNL. Mono (-). US of kidney and bladder WNL
CDC Split Type: WAES0801USA02867

Write-up: Information has been received from a physician concerning a 14 year old female with no medical history, who on 02-JAN-2008 was vaccinated with a first dose of Gardasil (Lot# 659653/1448U). Concomitant suspect vaccinations included Varivax. Other concomitant vaccinations included HAVRIX. On 03-JAN-2008 the patient experienced urinary urgency and frequency. On 03-JAN-2008 a urinary analysis was performed and showed a trace of blood in the urine. The patient improved within 48 hours. The patient then experienced right flank pain, chest pain with chills, and no fever. On 10-JAN-2008 the patient was admitted to the hospital and experienced nausea and loss of weight. The patient was better by 11-JAN-2008 and was released from the hospital. The patient recovered on an unspecified date. No product quality complaint was involved. Additional information has been requested. 03/03/2008 MR received for DOS 01/6-10/2008 with DX: Pyelonephritis. Pt presented to ED with c/o sudden onset flank pain (R chest, flank, back). Pt txd x 3 days for UTI sx of frequency and urgency). On abx.


VAERS ID: 303837 (history)  
Form: Version 1.0  
Age: 12.0  
Sex: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2008-01-28
Entered: 2008-01-29
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 1 UN / UN
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Cerebral haemorrhage, Head injury, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Haemorrhage terms (excl laboratory terms) (narrow), Arrhythmia related investigations, signs and symptoms (broad), Haemorrhagic central nervous system vascular conditions (narrow), Accidents and injuries (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 0 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0801USA03891

Write-up: Information has been received from a business manager for a physician concerning a 12 year old female who on an unknown date was vaccinated with her first dose of Gardasil. It was reported that the patient received four injections (therapy unspecified) at that time. Subsequently on an unknown date the patient experienced syncope, hit her head and cerebral bleeding and was hospitalized. It was reported that subsequently, on an unknown date, the patient had full recovery. This is one of several reports received from the same source. No further information is expected.


VAERS ID: 303838 (history)  
Form: Version 1.0  
Age: 19.0  
Sex: Female  
Location: Pennsylvania  
Vaccinated:2008-01-09
Onset:2008-01-09
   Days after vaccination:0
Submitted: 2008-01-28
   Days after onset:19
Entered: 2008-01-29
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 1522U / 2 LA / IM

Administered by: Other       Purchased by: Other
Symptoms: Immediate post-injection reaction, Injected limb mobility decreased, Pain in extremity, Wound, Wrong technique in drug usage process
SMQs:, Accidents and injuries (broad), Hypersensitivity (narrow), Tendinopathies and ligament disorders (broad), Medication errors (narrow)

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: ORTHO TRI-CYCLEN LO
Current Illness:
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data: None
CDC Split Type: WAES0801USA03962

Write-up: Information has been received from a licensed practical nurse concerning a 19 year old female with no pertinent medical history or drug reactions/allergies who on 12-NOV-2007 was vaccinated intramuscularly with a 0.5 ml first dose of Gardasil. On 09-JAN-2008 the patient was vaccinated intramuscularly in the left upper arm with a 0.5 ml second dose of Gardasil (659055/1522U). Concomitant therapy included ORTHO TRI-CYCLEN LO. On 09-JAN-2008 the patient developed pain to the arm right after receiving the injection. The pain radiates down the left arm and has gotten worse since the injection. The patient called and was seen by her family physician, who told her that the injection was given improperly into the tendon or ligament causing a puncture wound. The patient last saw the reporting physician on 14-JAN-2008. At that time there was no bruising noted at the site. The patient was not able to lift her left arm. The patient has been using TYLENOL, CELECOXIB, and heat as prescribed by her family physician. The patient''s outcome was reported as not recovered. The patient''s mother is requesting an MRI of the left arm, it has not been ordered at this time. There was no product quality complaint involved. Follow up information was received from the licensed practical nurse indicating that she would consider the patient to have temporary incapacity of her arm and therefore felt that the events were disabling. Additional information has been requested.


VAERS ID: 304025 (history)  
Form: Version 1.0  
Age: 24.0  
Sex: Female  
Location: Unknown  
Vaccinated:2007-11-20
Onset:2007-12-21
   Days after vaccination:31
Submitted: 2008-01-30
   Days after onset:40
Entered: 2008-01-31
   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: Biopsy muscle, Blood creatine phosphokinase increased, Electromyogram, Enzyme abnormality
SMQs:, Rhabdomyolysis/myopathy (broad), Neuroleptic malignant syndrome (broad), Myocardial infarction (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, 3 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: creatinine; DEPO-PROVERA; vitamins (unspecified)
Current Illness: Fibromyalgia; migraine
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: serum creatine kinase, 12/21/07, 50,00; serum creatine kinase, 12/21/07, 19,90
CDC Split Type: WAES0801USA04568

Write-up: Information has been received from a health professional concerning a 24 year old female with fibromyalgia (since age 14) and migraines on 20-NOV-2007 was vaccinated with a first dose of GARDASIL. Concomitant therapy included creatinine "supplements", multiple various vitamins (unspecified) and DEPO-PROVERA. The patient saw Rheumatologist on 21-DEC-2007 for a routine check-up and when blood was drawn. CK result came back later that day showing 19,900, patient was advised to go to the hospital. Upon admission, CK was 50,000. The patient had been exercising between the blood draws (no baseline CK level available). The patient was hospitalized for three days and received hydration. Discharge diagnosis was "enzyme deficiency". The patient had an EMG and muscle biopsy (dates unspecified) but results are not available. She was due for her second dose of GARDASIL but had canceled her appointment. Additional information has been requested.


VAERS ID: 304109 (history)  
Form: Version 1.0  
Age: 16.0  
Sex: Female  
Location: Vermont  
Vaccinated:2007-11-14
Onset:2007-11-14
   Days after vaccination:0
Submitted: 2008-01-25
   Days after onset:72
Entered: 2008-02-01
   Days after submission:7
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0929U / 1 LA / IM
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA) / SANOFI PASTEUR U2182AA / 1 RA / IM

Administered by: Private       Purchased by: Public
Symptoms: Bradycardia, Electrocardiogram, Laboratory test, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 2 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Yaz
Current Illness: none
Preexisting Conditions: none
Allergies:
Diagnostic Lab Data: Labs EKG - Seen by cardiologist ER LABS: CBC, chemistry, cardiac enzymes, UA all WNL. Hospital LABS: EKG revealed bracycardia. Echocardiogrm WNL. Stress test WNL.
CDC Split Type:

Write-up: Immediately after shots - became Faint with pulse 50; Next Am had syncopal episode -$g ER -$g hosp Adm. with significant bradycardia -$g cardiac work-up; now on Atenolol. 2/1/08 Reviewed ER medical records of 11/15/07 which reveal patient experienced feeling lightheaded, warmth & nauseated. Felt faint, lost consciousness & collapsed for approx 1 min witnessed by parent. Recovered at the scene. In ER placed on O2. Had additional episodes of syncope w/HR 30''s while laying on gurney in ER. Noted to have eye twitching, pallor & eyes rolling back in head, flaccid. Awoke immediately but was very tired. Transferred to higher level of care. FINAL ER Dx: syncope of unknown cause. 2/8/08 Reviewed hospital medical records which reveal patient admitted to PICU 11/15-11/16/2007. Cardio consult done. Syncopal episodes felt to be neurocardiogenic w/significant cardioinhibitory component, resulting in secondary bardycardia/asystole & syncope. Tx w/meds & hydration & d/c to home w/cardio f/u. FINAL DX: syncope, probably neurally-mediated syncope; periods of marked bradycardia.


VAERS ID: 304202 (history)  
Form: Version 1.0  
Age: 22.0  
Sex: Female  
Location: New Jersey  
Vaccinated:2007-02-01
Onset:0000-00-00
Submitted: 2008-02-01
Entered: 2008-02-04
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0187U / UNK UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Cervical conisation, Colposcopy, Smear cervix abnormal
SMQs:

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? Yes
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown PMH: BCPs.
Allergies:
Diagnostic Lab Data: Colposcopy; cervix conization 05/03/07; Pap test - abnormal
CDC Split Type: WAES0801USA05252

Write-up: Information has been received from a nurse concerning a 23 year old female patient who in February 2007, was vaccinated IM with a dose of Gardasil (lot# 656049/0187U). Subsequently the patient was diagnosed with cervical cancer and was hospitalized. The cold knife cone biopsy was performed on 03-May-2007 and "margins were clear". The cervix was still intact. In June 2007 the patient was recovered. The reporting investigator considered cervical cancer to be disabling. Upon internal review cervical cancer considered to be an other important medical event. No product quality complaint was involved. Additional information has been requested. 4/7/09 Received consultant medical records of 5/23/07-7/28/2008. FINAL DX: adenocarcinoma in situ Records reveal patient dx 3/2006 via LEEP procedure. Subsequent Pap smear abnormal w/HGSIL, cervical biopsies 2/07. Cold knife cone procedure in OR on 5/3/07 c/w CIN 2 w/marked changes of HPV infection. RTC 2/6/08 w/right pelvic pain & fatigue. Had recent colonoscopy for loose stools which was WNL. Colposcopy done at that visit was WNL. Referred to PCP for fatigue. RTC 7/28/08 w/fatigue, bilateral intermittent ovarian pain & pain w/intercourse. BCP d/c 7/08. Colposcopy done WNL. Referred for pelvic US.


VAERS ID: 304337 (history)  
Form: Version 1.0  
Age: 16.0  
Sex: Female  
Location: Louisiana  
Vaccinated:2008-01-22
Onset:2008-01-22
   Days after vaccination:0
Submitted: 2008-01-22
   Days after onset:0
Entered: 2008-02-05
   Days after submission:14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 1266U / 1 RA / IM
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA) / SANOFI PASTEUR U2323AA / UNK LA / IM

Administered by: Public       Purchased by: Unknown
Symptoms: Blood glucose, Convulsion, Electrocardiogram, Metabolic function test
SMQs:, Systemic lupus erythematosus (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 1 days
   Extended hospital stay? No
Previous Vaccinations: ~DTaP (no brand name)~3~1.00~In Patient
Other Medications:
Current Illness: None
Preexisting Conditions: None 2/14/08-records received-HX of psoriasis.
Allergies:
Diagnostic Lab Data: Accu check; CBC; CMP; EEG & EKG 2/14/08-records received-EEG normal awake and drowsy EEG. Labs within normal limits.
CDC Split Type:

Write-up: Seizure like episode lasting approx 10 seconds. 2/14/08-records received for DOS 1/22/08- Became light-headed after vaccination, eye began rolling back, unresponsive to voice. Began jerking movements of right and left arm and head. Post ictal state. 5/27/08-DC Summary received for DOS 1/22-1/23/08-DC DX: Reaction to HPV vaccine. Light headed few seconds after vaccination.


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