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Found 102 cases where Location is Texas and Vaccine is HPV or HPV2 or HPV4 and Serious

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VAERS ID: 272237 (history)  
Form: Version 1.0  
Age: 39.0  
Sex: Female  
Location: Texas  
Vaccinated:2007-01-30
Onset:0000-00-00
Submitted: 2007-02-08
Entered: 2007-02-14
   Days after submission:6
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0014U / 2 RA / -

Administered by: Private       Purchased by: Unknown
Symptoms:
SMQs:

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:
Current Illness: NONE
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: See note (attached) 02/15/2007-record received and reviewed. Office visit of 02/08/07-Assessment. Allergic reaction on chest back and left arm. Patient thinks it is related to Gardasil. Received treatment in Mexico. Treated with Betamethasone. Diagnosed with erythema multiforme. Right arm at injection site is not irritated or edematous. Allergic reaction mostly in the contralateral side.


VAERS ID: 278268 (history)  
Form: Version 1.0  
Age: 12.0  
Sex: Female  
Location: Texas  
Vaccinated:2007-04-24
Onset:2007-04-25
   Days after vaccination:1
Submitted: 2007-05-08
   Days after onset:13
Entered: 2007-05-09
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEPA: HEP A (VAQTA) / MERCK & CO. INC. - / UNK UN / UN
HIBV: HIB (PEDVAXHIB) / MERCK & CO. INC. - / UNK UN / UN
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 1 UN / UN
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA) / SANOFI PASTEUR - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Groin pain, Headache, Herpes zoster, Laboratory test normal, Meningitis viral, Rash
SMQs:, Anaphylactic reaction (broad), Osteonecrosis (broad), Hypersensitivity (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, 3 days
   Extended hospital stay? Yes
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Unknown PMH: hemolytic uremic syndrome requiring hospitalization & blood transfusions out of country, shingles 4/24/07. right wrist tendon injury & fracture of growth plate.
Allergies:
Diagnostic Lab Data: diagnostic laboratory 04/25/07 - negative LABS: WBC 4.4, AST 43, Mag 2.5. CK 292, MBs neg. CSF WBC 55, RBC 10, lymphs 86, monos 14, protein 28, glucose 44, pleocytosis of CSF. CSF herpes & VZ was neg. Blood & urine c/s neg. CT of head was WNL.
CDC Split Type: WAES0705USA00797

Write-up: Information has been received from a physician, via a company representative, concerning a 12 year old female patient who on 24-APR-2007 was vaccinated with the first dose of Gardasil. Concomitant therapy included hepatitis A virus vaccine (manufacturer unspecified), PedvaxHib and Menactra. On 25-APR-2007, the day following the vaccinations, the patient returned to the office with complaints of groin pain; blood work (unspecified) testing was performed, and was negative. On 30-APR-2007 the patient experienced a headache and a rash on her leg, and again returned to the physician''s office; the patient was diagnosed with zoster, and was given Tylenol and codeine for treatment of the symptoms. On 03-MAY-2007, the patient presented that the patient may have viral meningitis. At the time of this report, the physician reported that the patient may have viral meningitis. At the time of this report, the patient had not recovered from the events. Additional information has been requested. 5/18/2007 Received medical records from hospital which reveal patient experienced shingles, severe HA which continued to worsen, photosensitivity, nausea. Opthal exam prior to admit was WNL. Admitted 5/3-5/6/07. ID consult obtained. Treated w/IV antibiotics & antivirals. Symptoms resolved day after treatment started & patient continued to progress well. D/C home on no meds w/close outpatient PCP f/u. FINAL DX: meninigitis, presumed viral (aseptic), final c/s pending; HA, resolved; herpes zoster right leg suspected. 6/8/07 Received note from PCP stating CSF PCRs for HSV & entervirus were neg. Also included name of admitting physician at hospital where PCP does not have privileges.


VAERS ID: 280485 (history)  
Form: Version 1.0  
Age: 11.0  
Sex: Female  
Location: Texas  
Vaccinated:2007-04-15
Onset:2007-05-01
   Days after vaccination:16
Submitted: 2007-06-05
   Days after onset:35
Entered: 2007-06-06
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK - / -

Administered by: Other       Purchased by: Other
Symptoms: Aplastic anaemia, Aspiration bone marrow, Biopsy bone marrow, Contusion, Fatigue, Full blood count, Headache, Impaired healing, Menorrhagia, Pancytopenia, Viral test
SMQs:, Agranulocytosis (narrow), Haematopoietic cytopenias affecting more than one type of blood cell (narrow), Haematopoietic erythropenia (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Accidents and injuries (narrow), Myelodysplastic syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? Yes
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? Yes
Previous Vaccinations:
Other Medications:
Current Illness: none
Preexisting Conditions: none
Allergies:
Diagnostic Lab Data: CBC, Bone marrow aspirate & biopsy, Viral serologies records received 6/21/07-Bone marrow aspirate and biopsy showed absence of megakaryocytes and decreased erythroid and meyloid precursors. Presented with hemoglobin 4.9, WBC 3 and platelet count of 7 and ANC 200. PMH menorrhagia but no active bleeding at the time she was admitted. Parvovirus, EBV, DNA PCR, CMV are negative, Hepatitis core and Hepatitis A and B pending.
CDC Split Type:

Write-up: In early May, increased bruising, slower wound healing, severe bleeding with menstruation, intermittent headaches, fatigue. Admitted to medical center on 06/01/07 following referred from primary pediatrician with pancytopenia. Diagnosed with aplastic anemia. Treatment to be determined. 6/21/07-records received for DOS 6/1-6/5/07-DC DX: Severe pancytopenia. status post transfusion of RBC times 2 and platelets times 1. Seen in ER on 6/1/07 for increased bruising and pancytopenia on her blood smear. No evidence of ITP. Severe aplastic anemia.


VAERS ID: 286564 (history)  
Form: Version 1.0  
Age: 11.0  
Sex: Female  
Location: Texas  
Vaccinated:2007-07-05
Onset:2007-07-13
   Days after vaccination:8
Submitted: 2007-08-02
   Days after onset:20
Entered: 2007-08-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEPA: HEP A (VAQTA) / MERCK & CO. INC. 0246U / 2 RA / IM
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0802U / 1 LA / IM
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. 0535U / 2 RA / SC

Administered by: Unknown       Purchased by: Unknown
Symptoms: Blood glucose increased, Diabetes mellitus insulin-dependent
SMQs:, Hyperglycaemia/new onset diabetes mellitus (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, 3 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: glucose - 977 records received 8/30/07-WBC 10.5. Segs 85. Postassium 5.6. carbon dioxide 18.9. Anion Gap of 33, Phosporus 6.6. osmolality of 322. Blood sugar greater than 900.
CDC Split Type:

Write-up: Came to office 1 week after immunizations were given with New onset Type 1 DM with sugar of 977. 8/30/07-records received-for DOS 7/13-7/15/07- DC DX: Diabetic ketoacidosis resolved. Type I diabetes new onset. Dehydration resolved. Hyperkalemia, resolved. Two week history of polyuria, polydipsia, nocturia, dry mouth and blurry vision, 12 pound weight loss for the last month or so. in ED blood sugar over 1000. C/O not feeling well, weak, decreased appetite, nausea and vomiting. 1/11/2010 Patient has type I DM.


VAERS ID: 287887 (history)  
Form: Version 1.0  
Age: 18.0  
Sex: Female  
Location: Texas  
Vaccinated:2007-04-16
Onset:2007-04-16
   Days after vaccination:0
Submitted: 2007-08-10
   Days after onset:116
Entered: 2007-08-13
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 1 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Anaphylactic reaction, Loss of consciousness, Urticaria
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (narrow), Angioedema (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Anaphylactic/anaphylactoid shock conditions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
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: WAES0708USA00643

Write-up: Information has been received from a registered nurse, via a company representative, concerning a non-pregnant, 18 year old female patient, who on 16-APR-2007 was vaccinated IM, with the first dose, 0.5ml, of Gardasil (Lot # not provided). On 16-APR-2007, "shortly after being administered the vaccine" the patient had an anaphylactic reaction, described as, she developed hives down both arms but did not have difficulty breathing; she also passed out. Treatment included Benadryl, and oxygen, and the patient was observed in the office for a "short time" and then went home. The patient then fully recovered (duration not reported). The nurse considered anaphylactic reaction and "passing out" to be serious, as life-threatening and as an important medical event. No further information is expected.


VAERS ID: 288458 (history)  
Form: Version 1.0  
Age: 19.0  
Sex: Female  
Location: Texas  
Vaccinated:2007-08-06
Onset:2007-08-06
   Days after vaccination:0
Submitted: 2007-08-17
   Days after onset:11
Entered: 2007-08-20
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0929U / 1 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Abdominal pain, Blood thyroid stimulating hormone normal, Diarrhoea, Full blood count normal, Nausea, Vomiting
SMQs:, Acute pancreatitis (broad), Retroperitoneal fibrosis (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (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: OVCON
Current Illness:
Preexisting Conditions: Cholecystectomy
Allergies:
Diagnostic Lab Data: complete blood cell 08/07/07 normal; serum TSH 08/07/07 normal
CDC Split Type: WAES0708USA01429

Write-up: Information has been received from a registered nurse concerning a 19 year old female patient with a history of cholecystectomy (FEBRUARY 2005) and no allergies who on 06-AUG-2007, was vaccinated IM with a first 0.5ml dose of Gardasil (Lot # 658282/0929U). Concomitant therapy included ethinyl estradiol/norethidrone (OVCON). About 2 hours after receiving the vaccine, the patient experienced severe abdominal pain, nausea, vomiting and diarrhea. The patient stated that the area that hurts was about 2 inches from her belly button. The patient was prescribed atropine sulfate (+) diphenoxylate hydrochloride (LOMOTRIL) and promethazine hydrochloride (PHENERGAN). It was reported that the next day the patient called the office and her stomach pain had gotten worse. On a scale of 1 to 10 the patient felt her pain was a six. Laboratory diagnostic studies given on 07-AUG-2007 included a CBC and a thyroid study. Both were reported as normal. The patient no longer has diarrhea but was still experiencing nausea and vomiting. The outcome of severe abdominal pain was unknown. No product quality complaint was involved. Severe abdominal pain, nausea, vomiting and diarrhea were considered to be disabling. Additional information has been requested.


VAERS ID: 289694 (history)  
Form: Version 1.0  
Age: 15.0  
Sex: Female  
Location: Texas  
Vaccinated:2007-08-22
Onset:2007-08-22
   Days after vaccination:0
Submitted: 2007-08-24
   Days after onset:2
Entered: 2007-09-04
   Days after submission:11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0927U / 2 LA / IM

Administered by: Public       Purchased by: Private
Symptoms: Confusional state, Laboratory test
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? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 4 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: No
Preexisting Conditions: None. PMH: none. NKDA.
Allergies:
Diagnostic Lab Data: Per mother lab tests were done. Labs and Diagnostics: MRI brain unremarkable with the exception of a couple non-specific punctate foci of increased flair signal in the subcortical white matter of the frontal lobes. CMV and EBV IgG (+), IgM (-). Drug screen (-). Sed rate 10. CK 36. CRP <0.3.
CDC Split Type:

Write-up: Per mother 2 hours after injection behavior changes, unaware of surrounding. Pt went to ER. In 4 days. pt returned to ER Blood test and MRI were done Per mom everything was normal. Pt discharged 8/28/07. 09/25/2007 MR received for DOS 8/23/2007 for D/C DX of Disorientation, weakness resolved and additional records for 8/24-28/07. Pt presented to ER x 2 with mental status changes, confusion, and dizziness. Was D/C after all labs were normal. Increasing fatigue and weakness in the BLEs resulted in return to ER. Confusion was improved at this time. PE shows 4/5 LE stength. Otherwise WNL. Neuro attending reports hx and exam not suggestive of severe neuro complication. Disorientation c/w orthostasis, improved with IVF. Discharged 8/27/07 in improved condition with normal exam.


VAERS ID: 295507 (history)  
Form: Version 1.0  
Age: 12.0  
Sex: Female  
Location: Texas  
Vaccinated:2007-07-24
Onset:2007-08-07
   Days after vaccination:14
Submitted: 2007-08-30
   Days after onset:23
Entered: 2007-11-05
   Days after submission:67
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 1447F / 1 UN / IM
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA) / SANOFI PASTEUR U2139AA / 1 UN / IM

Administered by: Private       Purchased by: Public
Symptoms: Ataxia, Azotaemia, Blood creatinine increased, Blood urea increased, Diplopia, Leukoencephalomyelitis, Muscular weakness, Nuclear magnetic resonance imaging brain abnormal
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (narrow), Noninfectious encephalopathy/delirium (broad), Demyelination (narrow), Ocular motility disorders (broad), Chronic kidney disease (narrow), Tumour lysis syndrome (broad), 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, 10 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: Hyperlipidemia, abnormal LFT''s, acanthosis, overweight. PMH: Fx forearm, allergies, possible LFT abnormalities. NKDA.
Allergies:
Diagnostic Lab Data: MRI brain - abnormal findings in mid brain and base of brain; Increased BUN/CR. Labs and Diagnostics: MRI brain markedly abnormal findings involving midbrain and base of the brain. CT brain unremarkable. Renal US normal. Barium swallow with no penetration or aspiration. Admission CBC unremarkable. CMP with normal BUN and Creatinine with elevations beginning 8/16/07: BUN 20-57, Creatinine 1.8-3.8. Serum glucose elevations began 8/17/07. CSF with (+) RBCs with (+) oligoclonal bands. CSF MBP 7.76. CSF culture (-). No fungi in CSF. CSF HSV (-).Phytanic and Pristanic Acids WNL. Urine creatinine 52. UA with 1+ bacteria. UC (+) for Gram - bacillus and staph species. Tox screen (-).
CDC Split Type: TX0791

Write-up: Pt presented to the clinic on 8/13/07 with 1 week history of diplopia, ataxia, and weakness of extremities R$gL. Pt was admitted to hospital on 8/14 and dx with acute disseminated encephalomyelitis and azotemia. Pt was treated with a 5 day course of Solumedrol and Prednisone taper started with improvement in all sx''s except diplopia. 12/26/2007 MR received for DOS 8/14-24/2007. No formal D/C DX noted but following diagnostic studies DX of ADEM is proposed. Child presented to ER with 6 day hx of double vision, 4 day hx of unsteady gait, extremity weakness (R$gL) and abnormal eye movements noted by dad. Pt began running into things and falling while walking. Weakness, pain and unsteady gait have worsened. PE (+) for decreased strength upper & lower extremities, 1 beat clonus bilat, CN III palsy, R exotropia. Neurologic sequelae: Pt became more encephalopathic during admission (ataxia and III CN palsy) so transfered to PICU. Pt developed deteriorating renal function/azotemia which worsened after CT contrast. Txd with IV and po steroids. Discharged on day 10 in stable condition with aspiration precautions. 12/28/2007 Spoke with reporter who states only sequelae at this time is some occasional double vision when pt gets tired. Other sx such as ataxia, dysphagia and renal function are now resolved.


VAERS ID: 295876 (history)  
Form: Version 1.0  
Age: 16.0  
Sex: Female  
Location: Texas  
Vaccinated:2007-08-28
Onset:2007-08-29
   Days after vaccination:1
Submitted: 2007-11-07
   Days after onset:70
Entered: 2007-11-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0929U / 1 UN / UN

Administered by: Private       Purchased by: Public
Symptoms: Blood lead, Dizziness, Migraine, Pallor
SMQs:, Anticholinergic syndrome (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No
Current Illness: No
Preexisting Conditions: No 1/3/08-records received-PMH: Seizures during phlebotomy and hair salon.
Allergies:
Diagnostic Lab Data: MRI; EEG; Lead testing 1/3/08-records received-EEG normal. Echocardiogram normal. 24 hour Holter monitor normal.MRI brain normal.CT normal.
CDC Split Type:

Write-up: During a blood test patient went pale and had a seizure. First had them 2 or 3 a day or more than 3 times per week during period of 8/29 to 10/11. Went to ER for testing on 9/11. Started taking Topamax on 10/18. Doctor described them as migraine induced seizures. 1/3/08-records received-clinic visit 11/20/07-seen in follow up of seizures, headache and dizziness without seizure risk factors. Bradycardia. First episode was approximately 4 years ago and next was approximately 18 months ago. Starting on 8/29/07-began having frequent spells and LOC, shaking of left leg and upper extremity. All other seizures are staring lasting 1-2 minutes with LOC. Fatigued. confused afterwards. Previously had daily headache now less frequent. 1/15/2010 She still has seizures 1 to 3 a month. She is on Topamax 25mg in am and 50 mg at night. This has helped control them to 1 upt to 3 a month.


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.


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