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Found 6,988 cases where Vaccine is HPV4 and Serious

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VAERS ID: 301598 (history)  
Form: Version 1.0  
Age: 15.0  
Sex: Female  
Location: Massachusetts  
Vaccinated:2007-05-09
Onset:2007-06-23
   Days after vaccination:45
Submitted: 2008-01-03
   Days after onset:194
Entered: 2008-01-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0387U / 2 LA / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Coagulation test normal, Contraception, Deep vein thrombosis, Thoracic outlet syndrome, Ultrasound scan abnormal, Venogram abnormal
SMQs:, Embolic and thrombotic events, venous (narrow), Malignancy related therapeutic and diagnostic procedures (narrow), Thrombophlebitis (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, 2 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Sprintec, Prozac, Restasis eye drops
Current Illness: None
Preexisting Conditions: Keratitis, Dysthymia, Anxiety Disorder 1/24/08-records received- PMH: depression, suicidial ideation OCP, keratitis.
Allergies:
Diagnostic Lab Data: Duplex Ultrasound positive for DVT. Hypercoagulable evaluation negative. Venography demonstrated thoracic outlet syndrome. Chest x-ray normal. US DVT. PT 10.3, INR 1, PTT 22.9.
CDC Split Type:

Write-up: Patient received first Gardasil vaccine on 3/7/07 and second Gardasil vaccine on 5/9/07. Patient developed a DVT in the right upper extremity subclavian and axillary veins on 6/23/07. At the time, she was also on oral contraceptives. She was subsequently found to have thoracic outlet syndrome in the same extremity. 1/24/08-records received for DC DX: Deep vein thrombosis, right arm. Depression. One day prior to admission noted dull pain in right shoulder, swelling developed of right shoulder and arm, then discoloration of distal arm. Treated with anticoagulant therapy.


VAERS ID: 302116 (history)  
Form: Version 1.0  
Age: 15.0  
Sex: Female  
Location: Utah  
Vaccinated:2007-11-06
Onset:2007-11-30
   Days after vaccination:24
Submitted: 2008-01-09
   Days after onset:40
Entered: 2008-01-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 1 LA / UN
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 1426F / 1 LA / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Blood test normal, Convulsion, Corrective lens user, Decreased appetite, Diplegia, Dizziness, Fatigue, Headache, Hypersomnia, Hypophagia, Loss of consciousness, Nuclear magnetic resonance imaging normal, Oral mucosal blistering, Sensation of heaviness, Weight decreased
SMQs:, Torsade de pointes/QT prolongation (broad), Severe cutaneous adverse reactions (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Convulsions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Depression (excl suicide and self injury) (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (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, 4 days
   Extended hospital stay? No
Previous Vaccinations: none~ ()~~0.00~Patient
Other Medications: none at the time of this shot
Current Illness: none at the time of the shot
Preexisting Conditions: none
Allergies:
Diagnostic Lab Data: had 2 MRI''s and blood workup reveals no infection or virus 1/18/08-records received-PE and EKG normal. Laboratory tests normal.
CDC Split Type:

Write-up: Blisters on roof of mouth paralysis in legs passing out, bad headaches in back of her head, not being able to eat much food or drink felt overly full onset of Guillain Barre syndrome, still passing out and feeling dizzy after 2 months heavieness in legs sleeping excessivly feeling fatigued alot. 1/18/08-records received for DOS 1/11/08-ER visit for syncopal episode. Previously hospitalized for diffuse neurologic complaints. Guillain-Barre syndrome ruled out with negative MRI. Continues to have syncopal episodes, occasional fatigue, stomach upset, decreased oral intake. Tachycardia, anxiety, rapid respirations and syncope. No memory loss. Referred to outpatient neurology and pediatric psychiatry. DX: Persistent syncopal episodes. Per information received from annual follow up, it has been almost 5 mos, she still passes out, she gets dizzy on a daily basis. she now has to wear glasses from the seizures and passing out. And has a hard time keeping food down. Has lost 25 lbs and always tired, very fatigued. Many stays in the Hosp. and many tests. My daughters only got one shot out of 3. I would like more answers, is this ever going to stop-and if you could recommend any immunization attorneys that would be great. 1/19/2010 Last time she had a seizure was 2 months ago it seems to be backing off accept for all last year.


VAERS ID: 302704 (history)  
Form: Version 1.0  
Age: 22.0  
Sex: Female  
Location: Florida  
Vaccinated:2007-12-17
Onset:2007-12-28
   Days after vaccination:11
Submitted: 2008-01-14
   Days after onset:17
Entered: 2008-01-15
   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: Confusional state, Headache
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (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? Yes, 18 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown PMH: traumatic L4 compression fracture 9 yrs prior to admit w/multiple back surgeries, extensive hardware & pain management services w/recent revision of implantable TENS insertion. Anxiety & depression. Allergies: tetrocycline & monocycline.
Allergies:
Diagnostic Lab Data: Unknown LABS: Initial labs WNL. Initial LP done w/CSF WNL. Antibody (+). Initial MRI of 12/30 WNL. Repeat MRI of 1/9/08 c/w ADEM. Repeat MRI prior to transfer to rehab c/w persistent encephalitis.
CDC Split Type: WAES0801USA01659

Write-up: Information has been received from a physician, via a company representative, concerning a 22 year old female patient, who on an unspecified date was vaccinated with the first dose of Gardasil (lot # not reported). "About two weeks after" the vaccination, also described as "recently," the patient was diagnosed with encephalomyelitis, and was hospitalized (details not provided). The physician noted that the patient experienced confusion and headaches. He added that the patient was not vaccinated at his office, but at an OB/GYN office. At the time of this report, the outcome of the events was unknown. The reporting physician considered encephalomyelitis to be disabling. Additional information has been requested. 2/29/08 Reviewed hospital medical records of 12/28/2007-1/15/2008 admission. FINAL DX: acute disseminated encephalomyelitis secondary to suspected Gardisil vaccination; chronic back pain secondary to traumatic fall. Consults: critical care, ID, neuro & neurosurgery. HPI: Patient went to ER due to HA, dizziness & N/V for a few days beginning 10-12 days s/p vaccination. Seen by pcp & dx w/UTI, tx w/antibiotics. No improvement & went to ER. Quickly developed mental status changes & was unresponsive to stimuli. Transferred to ICU & intubated. Failed extubation & was re-intubated. Able to progress & successfully extubated. Tx w/antibiotics, antivirals & high dose steroids. Progressed very slowly & incompletely, able to walk only a few steps, off balance & incontinent of urine. Transferred to inpatient rehab center.


VAERS ID: 302705 (history)  
Form: Version 1.0  
Age: 20.0  
Sex: Female  
Location: Illinois  
Vaccinated:2007-11-01
Onset:2007-11-01
   Days after vaccination:0
Submitted: 2008-01-14
   Days after onset:74
Entered: 2008-01-15
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Dehydration, Drug exposure during pregnancy, Laboratory test
SMQs:, Hyperglycaemia/new onset diabetes mellitus (broad), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Dehydration (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, 0 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Vitamins (unspecified)
Current Illness: Pregnancy NOS (LMP = 10/22/2007)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Diagnostic laboratory - results not reported
CDC Split Type: WAES0801USA01347

Write-up: Information has been received from a 20 year old female with no pertinent medical history who on 01-Nov-2007 was vaccinated with a 0.5 ml dose of Gardasil. Concomitant therapy included prenatal vitamins. On 05-Jan-2008 the patient was dehydrated. She was hospitalized where she found out that she was pregnant with twins. The patient''s last menstrual period was approximately 22-Oct-2007 and estimated date of delivery was 28-Jun-2008. On 07-Jan-2008, the patient was released from the hospital. The patient''s outcome was not reported. Additional information has been requested.


VAERS ID: 302707 (history)  
Form: Version 1.0  
Age: 17.0  
Sex: Female  
Location: California  
Vaccinated:2008-01-04
Onset:2008-01-04
   Days after vaccination:0
Submitted: 2008-01-14
   Days after onset:10
Entered: 2008-01-15
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 1264U / 1 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Cough, Dyspnoea, Pharyngeal oedema, Pyrexia
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Oropharyngeal allergic conditions (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness:
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data: None
CDC Split Type: WAES0801USA00959

Write-up: Information has been received from a medical assistant concerning a 17 year old female with no medical history and no drug allergies, who on 04-JAN-2008 was vaccinated intramuscularly with a 0.5mL first dose of Gardasil (Lot# 658488/1264U). There was no concomitant medication. On 04-JAN-2008 four or five hours post vaccination the patient experienced difficulty in breathing, shortness of breath, and a swollen throat. The symptoms lasted about 6 hours and then the patient developed a "high fever" and a cough that lasted about 2 days. The patient called the office. The patient was not hospitalized. No laboratory diagnostics were performed. On 06-JAN-2008 the patient recovered. No product quality complaint was involved. The physician considered the difficulty breathing, shortness of breath, swollen throat, "high fever", and cough to be life threatening. Additional information has been requested.


VAERS ID: 302709 (history)  
Form: Version 1.0  
Age: 15.0  
Sex: Female  
Location: Unknown  
Vaccinated:2007-12-31
Onset:2007-12-31
   Days after vaccination:0
Submitted: 2008-01-14
   Days after onset:14
Entered: 2008-01-15
   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: Computerised tomogram normal, Head injury, Loss of consciousness, Syncope, X-ray
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), Accidents and injuries (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad)

Life Threatening? Yes
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: Liver transplant
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: computed axial - head and neck - no results reported; X-ray - no results reported
CDC Split Type: WAES0801USA00501

Write-up: Information has been received from a mother concerning her 15 year old daughter who has had a liver transplant. There were multiple concomitant medications but none were specified. On 31-DEC-2007 the patient was vaccinated with her first dose of Gardasil. The mother reported that her daughter fainted within 10 minutes after receiving the vaccination. She passed out for about 1 minute after hitting her head. She was seen in the emergency room and required 7 staples in her head to close the wound she received. A CT of the head and neck was performed, as well as X-rays. No results were reported. Her head injury was considered to be immediately life-threatening and disabling. Additional information has been requested.


VAERS ID: 303110 (history)  
Form: Version 1.0  
Age: 18.0  
Sex: Female  
Location: Massachusetts  
Vaccinated:2007-03-29
Onset:2007-04-13
   Days after vaccination:15
Submitted: 2008-01-07
   Days after onset:269
Entered: 2008-01-16
   Days after submission:9
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0188U / 1 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Guillain-Barre syndrome
SMQs:, Peripheral neuropathy (narrow), Guillain-Barre syndrome (narrow), Demyelination (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, 10 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: [therapy unspecified]
Current Illness: General symptom
Preexisting Conditions: PMH: Spinal sub-dural hematoma, Asthma, Migraines, Endometriosis, Bipolar Depression, Hep B. Allergy to codeine.
Allergies:
Diagnostic Lab Data: Unknown. Labs and Diagnostics: EMG/NCS suggestive of GBS.
CDC Split Type: WAES0712USA01735

Write-up: Information has been received from a physician, via a company representative, concerning an 18 year old female patient with a "lengthy medical history" (details not provided), who on 29-MAR-2007 was vaccinated with the first dose of Gardasil (lot #657006/0188U). Concomitant therapy included a "lengthy medication list" (medications not provided). On 13-APR-2007, 15 days after vaccination, the patient experienced symptoms of Guillain Barre syndrome. On 14-APR-2007, she was admitted to the hospital, and was discharged on 22-APR-2007 (details not provided). On 25-APR-2007, the patient was again admitted to the hospital, and released on 27-APR-2007 (details not provided). At the time of this report, the patient was recovering from the event. Additional information has been requested. 02/29/2008 Per email from CDC: CDC''s CISA staff has determined this case to be GBS Brighton level 2. 02/29/2008 MR received from CDC for visits from 5/2007 to 7/2007 from multiple sources including neurology. DX: Guillain-Barre Syndrome. Pt presented to ER 4/12/2007 with c/o leg weakness with PE suggestive of GBS (bilateral ascending paresthesias and weakness). LP defered due to hx of spinal subdural hematoma. Txd with IVIG. Admitted until 4/23/07. Re-admitted 4/25/07 unable to walk and with c/o throat tremors, hand tremors, difficulty lifting objects, and increased fatigue. DTRs in lower extremities absent and decreased vibratory sensation. Improvement noted by 7/2007 OV with new c/o headaches.


VAERS ID: 303112 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Iowa  
Vaccinated:0000-00-00
Onset:2007-11-26
Submitted: 2008-01-07
   Days after onset:42
Entered: 2008-01-16
   Days after submission:9
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 3 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Dizziness, Headache
SMQs:, Anticholinergic syndrome (broad), Vestibular 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: None
Current Illness:
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data: None
CDC Split Type: WAES0712USA01715

Write-up: Information has been received from a medical assistant (MA), concerning a female patient (age not specified) with no pertinent medical history and no known allergies, who was vaccinated (date not specified) with the third dose of Gardasil (lot # not reported). There was no concomitant medication. After the third vaccination, on 26-NOV-2007 (time duration to onset not specified), the patient experienced headaches, and dizziness that has been so severe, that "she needed to sit down very often." At the time of this report, the patient had not recovered. The MA considered the events to be serious as disabling/incapacitating. Additional information has been requested.


VAERS ID: 303008 (history)  
Form: Version 1.0  
Age: 17.0  
Sex: Female  
Location: California  
Vaccinated:2007-10-01
Onset:2007-10-01
   Days after vaccination:0
Submitted: 2008-01-17
   Days after onset:108
Entered: 2008-01-18
   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: Abortion spontaneous, Drug exposure during pregnancy, Emotional distress
SMQs:, Depression (excl suicide and self injury) (broad), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Termination of pregnancy and risk of abortion (narrow)

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? Yes, 0 days
   Extended hospital stay? Yes
Previous Vaccinations:
Other Medications: Unknown
Current Illness: Pregnancy NOS (LMP=Unknown)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0801USA02992

Write-up: Information has been received via the Merck pregnancy registry, from a physician, concerning a 17 year old female patient who was 2-3 weeks pregnant in October 2007, when she was vaccinated with the first dose of Gardasil (lot # not reported). On 13-JAN-2008, the patient had a miscarriage and was hospitalized (details and dates not provided). The physician stated that the patient was "traumatized." At the time of this report, the outcome of miscarriage and patient traumatized was unknown. The physician considered the miscarriage to be disabling/incapacitating due to the patient being traumatized. Additional information has been requested.


VAERS ID: 304011 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2007-01-15
Entered: 2008-01-21
   Days after submission:371
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / IJ

Administered by: Other       Purchased by: Other
Symptoms: Vomiting
SMQs:, Acute pancreatitis (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: Unknown
CDC Split Type: WAES0712USA06932

Write-up: Information has been received from a physician concerning a female who was vaccinated with 0.5 ml of Gardasil via injection. The patient developed severe vomiting after receiving the vaccination. Lot number was not provided. The physician stated that the patient was hospitalized, but did not know for how many days. No further information was provided. As of 13-DEC-2007 the patient was recovering. Additional information has been requested. Follow up information has been received on 22-FEB-2008. The nurse reported that the physician has no further adverse event information to provided. No further information is expected.


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