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Found 6894 cases where Vaccine is HPV4 and Serious

Case Details

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VAERS ID: 293285 (history)  
Form: Version 1.0  
Age: 26.0  
Sex: Female  
Location: Minnesota  
Vaccinated:2007-10-03
Onset:2007-10-08
   Days after vaccination:5
Submitted: 2007-10-12
   Days after onset:4
Entered: 2007-10-16
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 1061U / 1 LA / UN

Administered by: Private       Purchased by: Unknown
Symptoms: Asthenia, Back pain, Dizziness, Injection site nodule, Macroangiopathy, Protein total decreased
SMQs:, Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Guillain-Barre syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Vestibular disorders (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:
Other Medications: Relafen 750mg QD
Current Illness: None
Preexisting Conditions: Endometriosis; Chronic Pain - off methadone. PMH: Endometriosis with multiple surgeries. Depression. Gastritis. MVA 1998 w/ concussion. Chronic H/A. Migraines. Breast reduction. Laminectomy. Allergy to Compazine
Allergies:
Diagnostic Lab Data: None. labs and Diagnostics: EKG-sinus rhythm. EEG no epileptiform activity. Head CT(-). CT cervical spine (-). CT chest-no evidence for PE, nodular infiltrate of the lingula. Echocardiogram (-) for PFO. MRI brain with bifrontal subcortical white matter hyperintensities which may represent chronic microvascular changes, greater than expected for age. Serum K+ 3.2 and Cl- 112-115 on admission. Serum glucose 78.
CDC Split Type:

Write-up: Syncope episodes. 10/25/2007 MR received for DOS 10/08-12/2007 for D/C DX: Syncopal episodes thought to be likely 2'' to HPV vaccine administration. Orthostasis (contributing factor to syncopal episodes). Acute on chronic headache. Chronic low back pain. Chronic pain syndrome. Depression. Nodule infiltrate on lingula per CT scan. Pt presented to ER with c/o multiple syncopal episodes. Pt developed nausea and H/A ~ 15 minutes after HPV vax. Within 30" she had 1st syncopal episode where pt fell and hit her head. MD recommended increased po fluids and Benadryl, however pt had another episode that pm. En route to ER pt lost consciouness for few seconds. Pt was discharged from ER (10/3/07) but had 5 more syncopal episodes over the next several days. Also c/o generalized weakness, decreased appetite, and tiredness. Pt had cardiac and neuro consults. Pt was found to be orthostatic and several medications were d/cd as they may havbe been contributing. Last syncopal episode was 10/9/07 Per 60 day follow up: Patient with residual dizziness & fainting spells, currently being evaluated by neurology and cardiology.


VAERS ID: 293388 (history)  
Form: Version 1.0  
Age: 18.0  
Sex: Female  
Location: New York  
Vaccinated:2007-06-13
Onset:2007-10-06
   Days after vaccination:115
Submitted: 2007-10-12
   Days after onset:6
Entered: 2007-10-17
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0389U / 2 RA / UN

Administered by: Other       Purchased by: Other
Symptoms: Chills, Computerised tomogram abnormal, Death, Headache, Malaise, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2007-10-08
   Days after onset: 2
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical history and concomitant medications not reported; it was unknown if the patient was ill at time of vaccination.
Allergies:
Diagnostic Lab Data: 07/Oct/2007: Brain CT showed meningococcal disease ER LABS: CT scan & CXR WNL. WBC 14.9 (H), Neutros 87.2 (H), lymphs 6.4 (L). Creatinine 1.2 (H), ALT 27 (L). CSF WBC 4455 (H), RBC 171 (H), neutros 100% (H), glucose 29 (L), protein 371 (H). Blood & urine cultures neg. CSF (+) neisseria meningitidis. Hospital LABS: bronchoscopy & echocardiogram done prior to organ donation were WNL. CSF gram stain revealed neisseria species. WBC 19.1, neutros 86 (H), lymphs 5 (L). CRP 19.3 (H).
CDC Split Type: 200703414

Write-up: This case was received from a health care professional on 10 October 2007. Additional information was received from a newspaper article. An 18-year-old female patient received a meningococcal vaccine (name, manufacturer, and lot number not reported) on an unspecified date. The patient, who was a college freshman, travelled on 05 October 2007 to visit her family for the weekend. She reportedly felt "slightly ill" upon her arrival, and subsequently took an aspirin and went to bed, awakening at 1:30pm the following afternoon ''appearing refreshed". She became feverish again that night, and awoke at 1:00am the morning of 07 October 2007 with chills and a severe headache, complaining that "my head is about to explode". She was taken to a local hospital, where a CAT scan of the brain revealed meningococcal disease in her brain and brain stem. She was immediately transferred to another hospital, and died that evening of 07 October 2007 due to complications of meningitis. The health department noted that "lab tests have not yet confirmed the strain of meningitis" but that it was "likely the type not prevented by the vaccination". Past medical history and concomitant medications were unknown: it was not known if the patient was ill at the time of vaccination. 10/18/07 Patient name received from FDA. 10/18/07 Received death certificate from funeral home which states COD as brain death due to cerebral herniation and meningoencephalitis. 10/26/07 Received vax record from pcp which indicates patient received HPV & Menactra on 5/10/2007. VAERS database updated w/same. Vax record indicates patient also received 2nd dose of HPV 6/13/2007, Lot # 0523U, left arm. 11/27/07 Reviewed hospital medical records which reveal patient experienced HA, fever & neck pain x 1 day. Had come home from college 10/5 & developed chills next day. Seen in outlying ER where LP showed high pressure, grossly purulent CSF growing meningococcus. Intubated & IV antibiotics started & transferred to higher level of care. Neurosurgery & ID consults done. Pupils dilated & nonreactive. Diffuse cerebral edema leading to brain herniation & death. 12/4/07 Reviewed ER medical records which reveal patient seen 10/7/2007. Patient experienced pale, nausea, fever, chills, HA, neck stiffness, back ache & photophobia. Temp in ER max 104.7 Became nonresponsive w/posturing in ER. Intubated. Started on IV antibiotics & transferred to higher level of care.


VAERS ID: 293409 (history)  
Form: Version 1.0  
Age: 19.0  
Sex: Female  
Location: Unknown  
Vaccinated:2007-06-28
Onset:2007-07-12
   Days after vaccination:14
Submitted: 2007-10-16
   Days after onset:96
Entered: 2007-10-17
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 3 UN / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Granuloma, Hypoaesthesia, Injection site mass, Injection site pain, Nuclear magnetic resonance imaging abnormal, Pain, Tremor, Ultrasound scan abnormal
SMQs:, Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Malignancy related therapeutic and diagnostic procedures (narrow), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Extravasation events (injections, infusions and implants) (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: Levora
Current Illness: Penicillin allergy
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: upper extremity X-ray ?/?/07 - fluid collection; magnetic resonance ?/?/07 - fluid collection in left arm; ultrasound ?/?/07 - guided aspiration revealed granulomatous reaction
CDC Split Type: WAES0710USA02817

Write-up: Information has been received from a dentist concerning his 19 year old daughter with penicillin allergy who on 28-Jun-2007 was vaccinated with her third dose of Gardasil. Concomitant therapy included ethinyl estradiol (+) levonorgestrel (LEVORA). On 12-Jul-2007 the patient experienced a large tender lump at the injection site in her left deltoid muscle. The area became progressively more painful with pain radiating up to the left shoulder and clavicle and down to the left ring finger. The patient was seen in the office and referred to an orthopedist. X-rays and an MRI of the left arm revealed fluid collection. Ultrasound guided aspiration revealed granulomatous reaction. The pain continued to worsen and on 10-Oct-2007 the patient experienced transient numbness of left hand lasting 15 minutes and hand tremor lasting 5 hours. The patient was scheduled to have a neurologic evaluation on 12-Oct-2007. It was reported that the patient''s adverse events were disabling. The patient has not recovered at this time. No further details were provided. Additional information has been requested.


VAERS ID: 293412 (history)  
Form: Version 1.0  
Age: 17.0  
Sex: Female  
Location: California  
Vaccinated:2007-08-01
Onset:0000-00-00
Submitted: 2007-10-16
Entered: 2007-10-17
   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: Back pain, Spinal fracture, X-ray abnormal
SMQs:, Retroperitoneal fibrosis (broad), Accidents and injuries (narrow), Osteoporosis/osteopenia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 0 days
   Extended hospital stay? Yes
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: X-ray - lumbar fracture
CDC Split Type: WAES0710USA02087

Write-up: Information has been received from a physicians assistant concerning a 17 year old female who in approximately August 2007 was vaccinated with a first dose of Gardasil. Subsequently the patient had a lot of back pain. On approximately 23-SEP-2007 was vaccinated with a second dose of Gardasil. On approximately 24-SEP-2007 the patient ended up going in the hospital the next day for severe back pain. After seeing a Rheumatologist and having an x-ray it was discovered she had a lumbar fracture. At the time of the report the patient''s outcome was unknown. It was determined that the mother and the patient seem to feel that the lumbar fracture was still due to Gardasil. Additional information has been requested.


VAERS ID: 293413 (history)  
Form: Version 1.0  
Age: 17.0  
Sex: Female  
Location: Tennessee  
Vaccinated:2007-07-05
Onset:2007-09-03
   Days after vaccination:60
Submitted: 2007-10-16
   Days after onset:43
Entered: 2007-10-17
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0523U / 1 UN / UN
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. 0601U / 2 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Ataxia, Dizziness, Headache, Multiple sclerosis, Myelitis transverse, Pain, Paraesthesia
SMQs:, Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Optic nerve disorders (broad), Demyelination (narrow), 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? Yes, 5 days
   Extended hospital stay? Yes
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown. PMH: none. NKDA
Allergies:
Diagnostic Lab Data: magnetic resonance - MS w/ transverse myelitis[[address]]Labs and Diagnostics: Thoracic/lumbar CT c/w transverse myelitis T11-L1-2. [[name]] MRI (+) for lesions c/w demyelinating process in cerebral hemispheres, corpus collosum, brain stem and cerebellum. CSF with WBC 58, RBC +, lymphs 57, monos 40 and protein 45.7. Myelin basic protein high at 9.0, no oligoclonal bands, CSF cx and gram stain (-), csf viral tests all (-)[[address]]
CDC Split Type: WAES0710USA02905

Write-up: Information has been received from a physician concerning a female who on 05-JUL-2007 was vaccinated with Gardasil (Lot # not reported). Suspect secondary therapy included Varivax (Oka/Merck). On 03-SEP-2007 the patient came back into the office with headache, bodyache, and tingling in hands. She then came back in on 10-SEP-2007 and 11-SEP-2007 with more pronounced symptoms of dizziness and ataxia. She had an MRI and was diagnosed with multiple sclerosis with transverse myelitis. On 13-SEP-2007 the patient was hospitalized, length of hospitalization was not provided. The patient''s multiple sclerosis persisted. Multiple sclerosis was considered to be disabling. Additional information has been requested. 8/14/2008 MR received for DOS 9/13-17/2007 with D/C DX: Multiple Sclerosis (most likely dx, monophasic at present). Pt presented with 1 week hx of generalized weakness and numbness in the bilateral fingers, 1 episode of urinary retention requiring catheterization and ataxia beginning 9/10/07. On exam, dysmetria, ataxia, R lower extremity weakness and nystagmus, pupillary defect (R$gL) noted. Tx with solumedrol with improvement in dysthesias and strength. F/u as outpt.


VAERS ID: 293533 (history)  
Form: Version 1.0  
Age: 25.0  
Sex: Female  
Location: Minnesota  
Vaccinated:2007-09-18
Onset:2007-09-19
   Days after vaccination:1
Submitted: 2007-10-18
   Days after onset:29
Entered: 2007-10-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 24026492 / 2 UN / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Computerised tomogram abdomen abnormal, Computerised tomogram normal, Eating disorder, Headache, Hypoaesthesia, Impaired work ability, Laboratory test normal, Nausea, Paraesthesia, Sinus congestion, Vomiting
SMQs:, Acute pancreatitis (broad), Peripheral neuropathy (broad), Retroperitoneal fibrosis (broad), Guillain-Barre syndrome (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, 3 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Ortho Tricyclen, Flonase
Current Illness: Upper respiratory illness
Preexisting Conditions: Allergic to Ceclor PPMH: Levaquin & ceclor allergies, migraines
Allergies:
Diagnostic Lab Data: Lab tests, ct or sinuses and head all normal LABS: MRI of brain WNL. US of RLE WNL. CT head WNL. CT abdomen & pelvis revealed possible fundal gallbladder stone or calcification & possible small cyst at lower pole of left kidney.
CDC Split Type:

Write-up: Patient developed sinus congestion, headache, nausea, and vomting. Symptoms worsened through the month and is now being admitted to the hospital with numbness and tingling of her leg. 11/09/2007 Reviewed hospital medical records which reveal patient experienced URI symptoms & fatigue soon after initial HPV vaccine. Then received 2nd dose HPV & symptoms worsened. Began to have sudden tingling & numbness of right foot & leg on 10/17 along w/nausea & extreme fatigue. Admitted 10/18-10/20/2007. Neurology consult done. FINAL DX: UTI; paresthesias of unclear etiology; possible conversion disorder; gallstones; probable GERD. Follow-up Information 20-DEC-2007: After receiving the 2nd dose of HPV Vaccination, 24 hours later I was light-headed, dizzy, nauseous, vomiting, severe headaches, sinusitis and had a bright red face. On October 18th I was hospitalized after 3 trips to the emergency room and numerous visits to my physician with severe nausea, and vomiting and inability to eat anything. I was treated unsuccessfully with Bactrim, Protonix, and Reglan. I received a CT Scan, MRI, Ultrasound, all that revelated nothing that could explain my symptoms other than what the vaccine has done to me, which seems to be unknown and not yet found. On November 15th I required a laparascopic cholecystectomy secondary to cholecystitis with cholelithiasis, my symptoms were the same as previous severe headaches, nausea, vomiting and inability to eat. The only thing that changed in my life was receiving the second dose of this vaccine on September 19th, 2007 and i have not been the same person since, I have been unable to work, eat regular meals or live the regualr life of a 25 year old.


VAERS ID: 293567 (history)  
Form: Version 1.0  
Age: 15.0  
Sex: Female  
Location: Ohio  
Vaccinated:2007-09-20
Onset:2007-09-23
   Days after vaccination:3
Submitted: 2007-10-17
   Days after onset:24
Entered: 2007-10-18
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR U2444AA / UNK RA / UN
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 1060U / 2 LA / UN

Administered by: Private       Purchased by: Public
Symptoms: Abdomen scan normal, 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? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 0 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Penicillin allergy
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0710USA03084

Write-up: Information has been received from a physician concerning a 15 year old female with penicillin allergy, with no illness at the time of vaccination whose reported weight was 154 pounds and whose reported height was 62.5 inches, who on 20-SEP-2007 was vaccinated into the left arm with the second dose of Gardasil, (Lot # 658556/1060U), and concomitantly was vaccinated into the right arm with influenza virus vaccine (unspecified), (manufacturer "Sanofi"), (Lot # U2444AA). It was reported that the patient had received previously "multiple" doses. In the afternoon (P.M.) of 23-SEP-2007 it was reported that the patient developed severe right-sided abdominal pain requiring hospitalization. It was reported that all laboratory test and abdominal scans were normal. It was reported that all pain resolved in 4-5 days. Subsequently, the patient recovered from severe right-sided abdominal pain reportedly on 29-SEP-2007. Additional information has been requested.


VAERS ID: 293569 (history)  
Form: Version 1.0  
Age: 40.0  
Sex: Female  
Location: California  
Vaccinated:2007-10-01
Onset:2007-10-01
   Days after vaccination:0
Submitted: 2007-10-17
   Days after onset:16
Entered: 2007-10-18
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 2 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Angioedema, Erythema, Inappropriate schedule of drug administration, Reflux oesophagitis, Throat tightness, Wrong drug administered
SMQs:, Anaphylactic reaction (narrow), Angioedema (narrow), Oropharyngeal allergic conditions (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Gastrointestinal nonspecific dysfunction (narrow), Hypersensitivity (narrow), Medication errors (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (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, 2 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: therapy unspecified; albuterol; XANAX; FLEXERIL; CLARINEX; ADVAIR; NEURONTIN; ATROVENT; PREVACID; metformin; SINGULAIR; potassium (unspecified); ZANTAC; DIOVAN
Current Illness: Metabolic syndrome; Cholesterol high; Blood sugar increased; Rheumatoid arthritis; Asthma
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES0710USA02823

Write-up: Information has been received from a physician concerning a 40 year old female with metabolic syndrome, high cholesterol, increased blood sugar, rheumatoid arthritis and asthma who on 01-OCT-2007 was inadvertently vaccinated with Gardasil. Concomitant therapy included lansoprazole (PREVACID), cyclobenzaprine hydrochloride (MSD), montelukast sodium (MSD), valsartan (DIOVAN), gabapentin (NEURONTIN), metformin, "Clonazapen" (therapy unspecified), desloratadine (CLARINEX), ranitidine HCl (ZANTAC), potassium (unspecified), fluticasone propionate 9+) salmeterol xinafoate (ADVAIR), albuterol, ipratropium bromide (ATROVENT) and alprazolam (XANAX). The physician reported that 30 minutes after the patient was vaccinated she experienced angioedema, reddness in her face, and a tightening in her throat. Since the patient was vaccinated, she frequented many emergency rooms and was admitted to the hospital for 2 days. The patient was treated with prednisone, diphenhydramine hydrochloride (Benadryl) and methylprednisolone acetate (Depo-medrol) and subsequently was recovering from the events. The physician believed that her symptoms were reflux due to the many medications that the patient was taking. The angioedema, reddness in face, tightening in throat, reflux and wrong drug administered were considered other important medical events. Additional information has been requested.


VAERS ID: 298121 (history)  
Form: Version 1.0  
Age: 18.0  
Sex: Female  
Location: Texas  
Vaccinated:2006-12-13
Onset:2007-06-12
   Days after vaccination:181
Submitted: 2007-10-12
   Days after onset:122
Entered: 2007-10-15
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0868F / 2 LA / UN

Administered by: Other       Purchased by: Other
Symptoms: Alpha 1 foetoprotein normal, Anaemia, Drug exposure during pregnancy, Headache, Ultrasound scan normal, Urine human chorionic gonadotropin positive, Vaginitis bacterial
SMQs:, Haematopoietic erythropenia (broad), Tumour markers (narrow), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Normal pregnancy conditions and outcomes (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? No
Previous Vaccinations:
Other Medications: None
Current Illness: Pregnancy NOS (LMP = 12/6/2006)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: diagnostic laboratory 04/23/07 - maternal serum alphafetoprotein test (MSAFP); ultrasound 04/24/07 - "nl", reason-screen; ultrasound 04/26/07 - "nl", reason-screen; urine beta-urine 01/??/07 - positive for pregnancy; urine beta-urine 02/??/07 - positive for pregnancy; Chest x-ray, 10/23/07, chest normal; Chest x-ray, 11/23/07, r greater than 1 patchy perihilar infiltrate suggest pneumonia with bronchitis no pleural
CDC Split Type: WAES0702USA03013

Write-up: Information has been received from a licensed visiting nurse (L.V.N.) concerning an 18 year old, female with no pertinent medical history and no drug reactions or allergies who on 27-SEP-2006 was vaccinated into the left deltoid with the first dose of 0.5 mL dose of GARDASIL, (Lot # 653736/0868F). There was no concomitant medication. On 13-DEC-2006, the patient was vaccinated into the left deltoid with the second 0.5 dose of GARDASIL, (Lot # 653736/0868F). The patient sought unspecified medical attention. The nurse reported that the patient presented to the pregnancy crisis center in January 2007 and a urine pregnancy test was performed, and the result was positive for pregnancy. It was reported that the patient presented to the physician''s office on 12-FEB-2007, and another urine pregnancy test was taken and the result was positive for pregnancy. In follow-up received from a physician concerning an 18 year old, white, female with no pertinent medical history and no drug reactions or allergies who 27-SEP-2006 was vaccinated into the left deltoid with the first 0.5 mL dose of GARDASIL, (Lot # 654540/0800F). On 13-DEC-2006, the patient was vaccinated into the left deltoid with the second 0.5 mL dose of GARDASIL, (Lot # 653736/0868F). The patient had a maternal serum alphafetoprotein test (screen) on 23-APR-2007 with the result of negative. The patient had an ultrasound (screen) on 24-FEB-2007 with results of normal limits ("nl") and an ultrasound (screen) on 26-APR-2007 with results of "nl". It was reported that the patient had a liveborn, normal, male infant on 17-SEP-2007 with no congenital anomalies and no complications or abnormalities. The infant''s weight was 7 pounds and 12.4 ounces, 20 inches in length, Apgar score 9/9, weeks from last menstrual period (LMP) 39 2/7 weeks, head circumference 13 inches. It was reported that the patient had bacterial vaginitis on approximately, 12-JUN-2007 and was treated for 7 days with FLAGYL, 500 mg, twice a day. On 24-JUL-2007, the patient was treated for a headache with DARVOCT-N 100, every 6 hours. The patient had anemia on 07-AUG-2007, and was treated with "tandem fe", (iron unspecified) every day. The patient was vaccinated with rubella virus vaccine (manufacturer unknown) one dose, on 19-SEP-2007 for prevention. It was reported that the estimated conception date was December 2006 or early January 2007. The patient did not have previous pregnancies, full term deliveries, pre-term deliveries, spontaneous abortions or miscarriages, elective terminations or fetal deaths. Additional information has been requested. Follow up information in the form of medical records from a neurology exam, performed on 11-MAR-2008 were received (aged 5 1/2 months). The neurolgoist documented that the infant had a history "notable for an interval ear infection, as well as RSV bronchiolitis. The infant was reported to be "well appearing child," with regular heart sounds. The neurologic exam indicated "he has diffuse low tone. Does bring his hands to midline, but is not yet rolling over. He has relatively good head control his reflexes are brisk and sysmetric. He moves all extremities sysmetrically. He smiles, he tracks. "The neurologist''s impression was "lesion-related epilepsy secondary to bilateral schirencephaly with evidence of mild motor delay and tone abnormalities (referred to new-onset seizures in January). Therapy continued with TRILEPTAL, no breakthrough seizures since discharge with referral for Early Childhood Intervention and genetics for family counseling, follow up in 3 months. Follow up information received from the mother''s OB/GYN indicated the office did not notice any abnormalities before the baby was born. However, the baby started presenting with some abnormalities after he was born. His head was larger than it was supposed to be. Additional information is not expected. All available medical records will be provided upon request.


VAERS ID: 298860 (history)  
Form: Version 1.0  
Age: 23.0  
Sex: Female  
Location: California  
Vaccinated:2007-09-04
Onset:2007-09-11
   Days after vaccination:7
Submitted: 2008-01-07
   Days after onset:118
Entered: 2007-10-15
   Days after submission:84
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0530U / 1 UN / IM

Administered by: Private       Purchased by: Other
Symptoms: Guillain-Barre syndrome, Hypoaesthesia, Intensive care, Muscular weakness, Nuclear magnetic resonance imaging, Sensory loss
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (narrow), Guillain-Barre syndrome (narrow), Noninfectious encephalopathy/delirium (broad), Demyelination (narrow)

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? Yes, 18 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: MOLTRIN; PROVERA
Current Illness: 12/18/07-records received-Vaginal bleed for 2 weeks after IUD placement. History of diarrhea one week ago which remained for 3 days and resolved spontaneously.
Preexisting Conditions: Pregnancy termination. 12/18/07-records received-HX cervical cancer 6 years ago.
Allergies:
Diagnostic Lab Data: Magnetic resonance 09/07/07 results not reported 12/18/07-records received-Labs: lymphs 51.2, mono 11.6, sed rate 25. Urinalysis WBC 188, RBC 27, e. coli. Pregnancy test positive. CSF protein 56, culture negative.
CDC Split Type: WAES0709USA01558

Write-up: Information has been received from a physician concerning a 23 year old female with a history of being seen in the emergency room with "IUD pregnancy terminated" on 27-AUG 2007. On 04-SEP-2007, the patient was vaccinated with HPV rL1 6 11 16 18 VLP vaccine (yeast) 0.5ml (# of doses not reported). Concomitant therapy was unspecified. On 04-SEP-2007, the patient was given a prescription to fill for medroxyprogesterone acetate (PROVERA) and ibuprofen (MOTRIN) at the same visit that the HPV rL1 6 11 16 18 VLP vaccine (yeast) was administered. It was unknown if the prescriptions were taken by the patient. On 07-SEP-2007, the patient experienced loss of feelings in her extremities and weakness that progressed until she was examined in the emergency room. On 07-SEP-2007, the patient was hospitalized for possible Guillain-Barre syndrome. The patient had a magnetic resonance imaging performed that was being evaluated. At the time of reporting the patient had not recovered and was in the intensive care unit. The reporting physician felt that the event was serious (Other Important Medical Event), immediately life-threatening, required hospitalization and was disabling. Additional information has been requested. 12/18/07-records received for DOS 9/10-9/28/07- DC DX: Guillain-Barre syndrome, quadriparesis, improving at time of discharge. Decreased mobility in self care. pregnancy has resolved. Urinary tract infection. See in ED wit 2 day history of weakness started in fingers/hands and leg pains. Difficulty walking, can not get up wlk or move legs and arms. Short of breath when she tries to talk. PE: reflexes absent in both lower and upper extremities. This is in follow-up to report(s) previously submitted on 10/12/2007 1/7/2008. Initial and follow-up information has been received from two physicians concerning a 23 year old female with a history of bein seen in the emergency room with "IUD-pregnancy terminated" on 27-AUG-2007. On 04-SEP-2007, the patient was vaccinated intramuscularly with a first 0.5 ml dose of GARDASIL (Lot #0530U) # of doses not reported. On 14/SEP/2007, the patient was given a prescription to PROVERA and MOTRIN at the same time that GARDASIL was administered. It was unknown if the prescriptions wore taken by the patient. On approximately, 11-SEP-2007, the patient experienced loss of feelings in her extremities and weakness that progressed. She presented to the emergency room, with Guillain Barre syndrome where she was examined. On approximately, 11-SEP-2007, the patient was hospitalized for possible Guillain-Barre syndrome. The patient had a magnetic resonance imaging performed that was being evaluated. At the time of reporting, the patient had not recovered and was in the intensive care unit. The reporting physician felt that the event was serious (Other Important Medical Event) immediately life-threatening, required hospitalization, and was disabling. A review of the release testing data revealed that 0530U conformed to all required testing at the time of product release. Additional information is not expected.


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