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This is VAERS ID 351972

History of Changes from the VAERS Wayback Machine

First Appeared on 12/8/2009

VAERS ID: 351972
VAERS Form:
Age:13.0
Gender:Female
Location:Georgia
Vaccinated:2007-11-13
Onset:2007-12-07
Submitted:2009-07-20
Entered:2009-07-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0522U / 0 UN / UN

Administered by: Other      Purchased by: Other
Symptoms: Abdominal pain upper, Alanine aminotransferase increased, Areflexia, Arthralgia, Aspartate aminotransferase increased, Asthenia, Back pain, Blood albumin decreased, Blood creatine decreased, Blood culture negative, Blood glucose increased, Blood potassium decreased, Blood urea decreased, C-reactive protein increased, Carnitine decreased, Chest X-ray abnormal, Computerised tomogram normal, Cough, CSF protein increased, Dehydration, Differential white blood cell count abnormal, Dyspnoea, Ear pain, Fall, Fatigue, Gait disturbance, Haematocrit decreased, Headache, Hyporeflexia, Joint swelling, Leukopenia, Lumbar puncture, Lumbar puncture abnormal, Mononucleosis heterophile test positive, Muscular weakness, Nerve conduction studies abnormal, Nuclear magnetic resonance imaging, Nuclear magnetic resonance imaging brain normal, Otorrhoea, Pain, Pain in extremity, Pain in jaw, Paraesthesia, Peroneal muscular atrophy, Pharyngitis, Photophobia, Platelet count decreased, Positive Rombergism, Protein total decreased, Pyrexia, Rash, Reflexes abnormal, Scoliosis, Swelling, Tooth impacted, Urinary tract infection, Viral infection, Vision blurred, Visual impairment, Weight decreased, White blood cell count decreased, X-ray of pelvis and hip normal, Activities of daily living impaired, Red cell distribution width increased, Blood alkaline phosphatase increased, Tympanic membrane disorder, CSF immunoglobulin increased, Oropharyngeal pain

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit (V2.0)? No
ER or Office Visit (V1.0)? Yes
ER or ED Visit (V2.0)? No
Hospitalized? Yes, days: 5     Extended hospital stay? No
Previous Vaccinations:
Other Medications: None
Current Illness:
Preexisting Conditions: Ear tube insertion; Adenoidectomy. 8/6/09 Multiple hospital inpatient, DC summary, and ER records. Ear infection, tonsillectomy, adenoidectomy. Recent URI. PMH: Pharyngitis. OM. Diarhea. HSV1. Hand pain. weight gain. Dysthymic disorder . Ear tubes. Family hx of CMT.
Allergies:
Diagnostic Lab Data: Spinal tap, there was protein in the spinal fluid. 8/6/09 Multiple hospital inpatient, DC summary, and ER records. LABS and DIAGNOSTICS: CBC - WBC 2.61 K/mm3 (L) Mono 14% (H). Urinalysis - protein trace, blood trace, WBC 6 /hpf (H), RBC 13
CDC 'Split Type': WAES0907USA01998

Write-up: Information has been received from a consumer concerning a 14 years old female with a history of tubes in ears when little and adenoids removed at age 2 years old and no drug reactions who on 13-NOV-2007 was vaccinated with the first dose of GARDASIL. There was no concomitant medication. The patient received the 2nd dose of GARDASIL on 16-JAN-2008 and the 3rd dose of GARDASIL on 23-MAY-2008. At the beginning of February 2009, the patient experienced weakness, pain, tiredness, terrible leg pain, shortness of breath, muscle weakness, every now and then the stomach bothers her, fever, and headache. The patient had been seen in the office and hospitalized. The patient has been in and out of the hospital. The unspecified physicians at the hospital thought the patient had Guillain Barre but later determined it is not. Two spinal taps, 3 CT scans, MRI, numerous X-rays and blood panels were performed. The results showed that there was protein in the spinal fluid. The patient is better but every now and then there is muscle weakness and joint pain throughout both arms, both legs and both feet. The patient was homebound for the rest of the school year and missed school from February to March in 2009. The patient was at the hospital with 17 different physicians. Weakness, pain, tiredness, terrible leg pain, shortness of breath, muscle weakness, stomach bothers her, fever, headache and joint pain throughout both arms, legs and feet were considered to be disabling and immediately life-threatening. Follow-up information has been received from a medical assistant concerning a 14 years old female who on 13-NOV-2007 was vaccinated with the first dose of GARDASIL (lot# 657737/0522U). The patient received the 2nd dose of GARDASIL (lot# 657737/0522U) on 16-JAN-2008 and the 3rd dose of GARDASIL (lot# 658094/0524U) on 23-MAY-2008. No other vaccines were administered at the time of the GARDASIL dose. A lot check has been initiated. Additional information has been requested. 7/24/09 MR received from PCP from 11/2007 to 4/13/09. In f


Changed on 2/14/2017

VAERS ID: 351972 Before After
VAERS Form:
Age:13.0
Gender:Female
Location:Georgia
Vaccinated:2007-11-13
Onset:2007-12-07
Submitted:2009-07-20
Entered:2009-07-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0522U / 0 UN / UN

Administered by: Other      Purchased by: Other
Symptoms: Abdominal pain upper, Alanine aminotransferase increased, Areflexia, Arthralgia, Aspartate aminotransferase increased, Asthenia, Back pain, Blood albumin decreased, Blood creatine decreased, Blood culture negative, Blood glucose increased, Blood potassium decreased, Blood urea decreased, C-reactive protein increased, Carnitine decreased, Chest X-ray abnormal, Computerised tomogram normal, Cough, CSF protein increased, Dehydration, Differential white blood cell count abnormal, Dyspnoea, Ear pain, Fall, Fatigue, Gait disturbance, Haematocrit decreased, Headache, Hyporeflexia, Joint swelling, Leukopenia, Lumbar puncture, Lumbar puncture abnormal, Mononucleosis heterophile test positive, Muscular weakness, Nerve conduction studies abnormal, Nuclear magnetic resonance imaging, Nuclear magnetic resonance imaging brain normal, Otorrhoea, Pain, Pain in extremity, Pain in jaw, Paraesthesia, Peroneal muscular atrophy, Pharyngitis, Photophobia, Platelet count decreased, Positive Rombergism, Protein total decreased, Pyrexia, Rash, Reflexes abnormal, Scoliosis, Swelling, Tooth impacted, Urinary tract infection, Viral infection, Vision blurred, Visual impairment, Weight decreased, White blood cell count decreased, X-ray of pelvis and hip normal, Activities of daily living impaired, Red cell distribution width increased, Blood alkaline phosphatase increased, Tympanic membrane disorder, CSF immunoglobulin increased, Oropharyngeal pain

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit (V2.0)? No
ER or Office Visit (V1.0)? Yes
ER or ED Visit (V2.0)? No
Hospitalized? Yes, days: 5     Extended hospital stay? No
Previous Vaccinations:
Other Medications: None
Current Illness:
Preexisting Conditions: Ear tube insertion; Adenoidectomy. 8/6/09 Multiple hospital inpatient, DC summary, and ER records. Ear infection, tonsillectomy, adenoidectomy. Recent URI. PMH: Pharyngitis. OM. Diarhea. HSV1. Hand pain. weight gain. Dysthymic disorder . Ear tubes. Family hx of CMT.
Allergies:
Diagnostic Lab Data: Spinal tap, there was protein in the spinal fluid. 8/6/09 Multiple hospital inpatient, DC summary, and ER records. LABS and DIAGNOSTICS: CBC - WBC 2.61 K/mm3 (L) Mono 14% (H). Urinalysis - protein trace, blood trace, WBC 6 /hpf (H), RBC 13 /hpf (H). CHEM - Glucose 122 mg/dL (H). CRP 1.030 mg/dL (H). Blood Culture - No Growth. Chest X-ray - Mild thoracolumbar dextroscoliosis. LABS and DIAGNOSTICS: CT Head - Normal. CBC - WBC 3.73 K/mm3 (L) HCT 34.8% (L) PLT 123 K/mm3 (L) PMN 17% (L) Band 14% (H) Lymph 59% (H) Lumbar Puncture - CSF Protein 86.0 mg/dL (H). CHEM - Glucose 100 mg/dL (H) Total Protein Serum 6.0 g/dL (L) Albumin Serum 3.3 g/dL (L) Alk Phos 191 U/L (H) AST 68 U/L (H) ALT 74 U/L (H). Numerous bacterial and viral serologies and cultu
CDC 'Split Type': WAES0907USA01998

Write-up: Information has been received from a consumer concerning a 14 years old female with a history of tubes in ears when little and adenoids removed at age 2 years old and no drug reactions who on 13-NOV-2007 was vaccinated with the first dose of GARDASIL. There was no concomitant medication. The patient received the 2nd dose of GARDASIL on 16-JAN-2008 and the 3rd dose of GARDASIL on 23-MAY-2008. At the beginning of February 2009, the patient experienced weakness, pain, tiredness, terrible leg pain, shortness of breath, muscle weakness, every now and then the stomach bothers her, fever, and headache. The patient had been seen in the office and hospitalized. The patient has been in and out of the hospital. The unspecified physicians at the hospital thought the patient had Guillain Barre but later determined it is not. Two spinal taps, 3 CT scans, MRI, numerous X-rays and blood panels were performed. The results showed that there was protein in the spinal fluid. The patient is better but every now and then there is muscle weakness and joint pain throughout both arms, both legs and both feet. The patient was homebound for the rest of the school year and missed school from February to March in 2009. The patient was at the hospital with 17 different physicians. Weakness, pain, tiredness, terrible leg pain, shortness of breath, muscle weakness, stomach bothers her, fever, headache and joint pain throughout both arms, legs and feet were considered to be disabling and immediately life-threatening. Follow-up information has been received from a medical assistant concerning a 14 years old female who on 13-NOV-2007 was vaccinated with the first dose of GARDASIL (lot# 657737/0522U). The patient received the 2nd dose of GARDASIL (lot# 657737/0522U) on 16-JAN-2008 and the 3rd dose of GARDASIL (lot# 658094/0524U) on 23-MAY-2008. No other vaccines were administered at the time of the GARDASIL dose. A lot check has been initiated. Additional information has been requested. 7/24/09 MR received from PCP from 11/2007 to 4/13/09. In f for sick visit 11/13/07 with c/o sore throat. DX: Fever HPV vax #1 given. Returned 12/7/07 with c/o back pain, body aches. Had been moving heavy boxes. DX: Pain Elbow. Shoulder Joint pain. PT had UA and dx with UTI. Returned 1/16/08 with c/o R ear pain. R TM bulging. DX: OM HPV#2 given. Several OVs for sore throat cough.DX: Pharyngitis, Acute. 3rd HPV 5/23/08 Continued ear pain with multiple visits. Knee pain 10/2008. Several ER visits for fever, dehydration, leg pain and swelling 3/2009. Later H/A. DX: Lymphadenopathy, H/A. Mononucleosis, infectious. Hospital f/u 4/3/09 for weakness and paresthesias. DX: Weight loss. GBS. Parent report 4/13/09 that pt has been falling a lot and has tingling in feet. To F/U with neurologist. 7/22/09 Partial hospital record rec''d for DOS 3/25-28/09 with D/C DX: Charcot Marie Tooth and 5/14-09 with same. Pt presented with worsening neck pain which radiates to fingers, L hip pain which radiates to toes, weakness, numbness of feet, . Recently hospitalized for GBS vs Charcot-Marie-Tooth Disease. Recent 18 lb weight loss. PE (+) stumbling gait, (+) Romberg, decreased reflexes. Labs: LFTs elevated. CSF protein increased. MRI brain WNL. CXR WNL. Nerve conduction studies abnormal. CSF IgG (H) 15.2. CSF protein 148. CSF Albumin (H) 87.2. Serum Albumin (L) 3.1, CBC WNL. Head CT (-). Monospot (+). 8/6/09 Multiple hospital inpatient, DC summary, and ER records. ER DOS 3/6/09. Assessment: Acute febrile illness, Viral syndrome, Proteinuria, leukopenia. Patient presents with fever, shortness of breath, bilateral ear pain. Bilateral leg pain, numbness, and tingling from knee to bottom of feet. Does not feel good. Decrease in appetite. Swelling in feet and legs. Fatigue. Blurred vision and seeing spots. ER DOS 3/10/09 - 3/11/09 Assessment: Acute febrile illness, fever with meningeal signs, increased liver function tests, Bandemia. Thrombocytopenia, hyperglycemia, impacted molar. Patient


Changed on 9/14/2017

VAERS ID: 351972 Before After
VAERS Form:(blank) 1
Age:13.0
Gender:Female
Location:Georgia
Vaccinated:2007-11-13
Onset:2007-12-07
Submitted:2009-07-20
Entered:2009-07-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0522U / 0 1 UN / UN

Administered by: Other      Purchased by: Other
Symptoms: Abdominal pain upper, Arthralgia, Asthenia, CSF protein increased, Dyspnoea, Fatigue, Headache, Lumbar puncture, Muscular weakness, Pain, Pain in extremity, Pyrexia, Activities of daily living impaired

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit (V2.0)? No
ER or Office Visit (V1.0)? Yes
ER or ED Visit (V2.0)? No
Hospitalized? Yes, days: 5     Extended hospital stay? No
Previous Vaccinations:
Other Medications: None
Current Illness:
Preexisting Conditions: Ear tube insertion; Adenoidectomy. 8/6/09 Multiple hospital inpatient, DC summary, and ER records. Ear infection, tonsillectomy, adenoidectomy. Recent URI. PMH: Pharyngitis. OM. Diarhea. HSV1. Hand pain. weight gain. Dysthymic disorder . Ear tubes. Family hx of CMT.
Allergies:
Diagnostic Lab Data: Spinal tap, there was protein in the spinal fluid. 8/6/09 Multiple hospital inpatient, DC summary, and ER records. LABS and DIAGNOSTICS: CBC - WBC 2.61 K/mm3 (L) Mono 14% (H). Urinalysis - protein trace, blood trace, WBC 6 /hpf (H), RBC 13 /hpf (H). CHEM - Glucose 122 mg/dL (H). CRP 1.030 mg/dL (H). Blood Culture - No Growth. Chest X-ray - Mild thoracolumbar dextroscoliosis. LABS and DIAGNOSTICS: CT Head - Normal. CBC - WBC 3.73 K/mm3 (L) HCT 34.8% (L) PLT 123 K/mm3 (L) PMN 17% (L) Band 14% (H) Lymph 59% (H) Lumbar Puncture - CSF Protein 86.0 mg/dL (H). CHEM - Glucose 100 mg/dL (H) Total Protein Serum 6.0 g/dL (L) Albumin Serum 3.3 g/dL (L) Alk Phos 191 U/L (H) AST 68 U/L (H) ALT 74 U/L (H). Numerous bacterial and viral serologies and cultu cultures negative. LABS: Infectious Mono (+). X-ray Hips/Pelvis WNL. MRI w & w/o Contrast - Nonspecific Findings. MRI Cervical/Thoracic/Lumbar w & w/o Contrast - Lumbar nonspecific findings. CBC - RDW 14.5% (H) PMN 35% (H) Lymph 54% (H). CHEM - BUN 4 mg/dL (L) Albumin Serum 3.1 (L) CPK 36 U/L (L) Carnitine 28 umol/L (L). CSF - IgG 15.2 mg/dL (H) Albumin 87.2 mg/dL (H) Protein 142.0 mg/dL (H). LABS and DIAGNOSTICS: CBC - RDW 14.3% (H). CHEM - Potassium 3.3 mEq/L (L) Glucose 100 mg/dL (H) Creatine 0.43 mg/dL (L). Labs: LFTs elevated. CSF protein increased. MRI brain WNL. CXR WNL. Nerve conduction studies abnormal. CSF IgG (H) 15.2. CSF protein 148. CSF Albumin (H) 87.2. Serum Albumin (L) 3.1, CBC WNL. Head CT (-). Monospot (+).
CDC 'Split Type': WAES0907USA01998

Write-up: Information has been received from a consumer concerning a 14 years old female with a history of tubes in ears when little and adenoids removed at age 2 years old and no drug reactions who on 13-NOV-2007 was vaccinated with the first dose of GARDASIL. There was no concomitant medication. The patient received the 2nd dose of GARDASIL on 16-JAN-2008 and the 3rd dose of GARDASIL on 23-MAY-2008. At the beginning of February 2009, the patient experienced weakness, pain, tiredness, terrible leg pain, shortness of breath, muscle weakness, every now and then the stomach bothers her, fever, and headache. The patient had been seen in the office and hospitalized. The patient has been in and out of the hospital. The unspecified physicians at the hospital thought the patient had Guillain Barre but later determined it is not. Two spinal taps, 3 CT scans, MRI, numerous X-rays and blood panels were performed. The results showed that there was protein in the spinal fluid. The patient is better but every now and then there is muscle weakness and joint pain throughout both arms, both legs and both feet. The patient was homebound for the rest of the school year and missed school from February to March in 2009. The patient was at the hospital with 17 different physicians. Weakness, pain, tiredness, terrible leg pain, shortness of breath, muscle weakness, stomach bothers her, fever, headache and joint pain throughout both arms, legs and feet were considered to be disabling and immediately life-threatening. Follow-up information has been received from a medical assistant concerning a 14 years old female who on 13-NOV-2007 was vaccinated with the first dose of GARDASIL (lot# 657737/0522U). The patient received the 2nd dose of GARDASIL (lot# 657737/0522U) on 16-JAN-2008 and the 3rd dose of GARDASIL (lot# 658094/0524U) on 23-MAY-2008. No other vaccines were administered at the time of the GARDASIL dose. A lot check has been initiated. Additional information has been requested. 7/24/09 MR received from PCP from 11/2007 to 4/13/09. In for sick visit 11/13/07 with c/o sore throat. DX: Fever HPV vax #1 given. Returned 12/7/07 with c/o back pain, body aches. Had been moving heavy boxes. DX: Pain Elbow. Shoulder Joint pain. PT had UA and dx with UTI. Returned 1/16/08 with c/o R ear pain. R TM bulging. DX: OM HPV#2 given. Several OVs for sore throat cough.DX: Pharyngitis, Acute. 3rd HPV 5/23/08 Continued ear pain with multiple visits. Knee pain 10/2008. Several ER visits for fever, dehydration, leg pain and swelling 3/2009. Later H/A. DX: Lymphadenopathy, H/A. Mononucleosis, infectious. Hospital f/u 4/3/09 for weakness and paresthesias. DX: Weight loss. GBS. Parent report 4/13/09 that pt has been falling a lot and has tingling in feet. To F/U with neurologist. 7/22/09 Partial hospital record rec''d for DOS 3/25-28/09 with D/C DX: Charcot Marie Tooth and 5/14-09 with same. Pt presented with worsening neck pain which radiates to fingers, L hip pain which radiates to toes, weakness, numbness of feet, . Recently hospitalized for GBS vs Charcot-Marie-Tooth Disease. Recent 18 lb weight loss. PE (+) stumbling gait, (+) Romberg, decreased reflexes. Labs: LFTs elevated. CSF protein increased. MRI brain WNL. CXR WNL. Nerve conduction studies abnormal. CSF IgG (H) 15.2. CSF protein 148. CSF Albumin (H) 87.2. Serum Albumin (L) 3.1, CBC WNL. Head CT (-). Monospot (+). 8/6/09 Multiple hospital inpatient, DC summary, and ER records. ER DOS 3/6/09. Assessment: Acute febrile illness, Viral syndrome, Proteinuria, leukopenia. Patient presents with fever, shortness of breath, bilateral ear pain. Bilateral leg pain, numbness, and tingling from knee to bottom of feet. Does not feel good. Decrease in appetite. Swelling in feet and legs. Fatigue. Blurred vision and seeing spots. ER DOS 3/10/09 - 3/11/09 Assessment: Acute febrile illness, fever with meningeal signs, increased liver function tests, Bandemia. Thrombocytopenia, hyperglycemia, impacted molar. Patient presents with continued fever. Pain right leg, numbness and tingling feet. Right ear ''draining yellow''. Feels swollen ''all over''. Headache and discomfort upper back. Neck stiff. ER / Inpatient DOS 3/24/09 to 3/28/09 Assessment: Fever, joint pain, headache Patient presented with fever. Pain in joints and weakness in lower legs. Knees ''give out''. Headache with photophobia. Pain on back of neck. Min reflexes, abnormal Rombergs, stumbling, falling, inability to run. Legs tingling. Rash. ER / Medical Observation DOS 5/13/09 - 5/14/09 Assessment: Paresthesias, joint swelling, recent history of Guillain-Barre syndrome. Charcot Marie Tooth. Patient presents again with weakness, body pain and fever, jaw pain, joint pain and swelling. Burning on urination. Weight loss, photophobia, neck pain. Areflexic. Wobbles in Rhomberg test. 9/22/09 ICD-9 codes received: 356.1, 357.0, 075, 781.3


Changed on 2/14/2018

VAERS ID: 351972 Before After
VAERS Form:1
Age:13.0
Gender:Female
Location:Georgia
Vaccinated:2007-11-13
Onset:2007-12-07
Submitted:2009-07-20
Entered:2009-07-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0522U / 1 UN / UN

Administered by: Other      Purchased by: Other
Symptoms: Abdominal pain upper, Arthralgia, Asthenia, CSF protein increased, Dyspnoea, Fatigue, Headache, Lumbar puncture, Muscular weakness, Pain, Pain in extremity, Pyrexia, Activities of daily living impaired

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit (V2.0)? No
ER or Office Visit (V1.0)? Yes
ER or ED Visit (V2.0)? No
Hospitalized? Yes, days: 5     Extended hospital stay? No
Previous Vaccinations:
Other Medications: None
Current Illness:
Preexisting Conditions: Ear tube insertion; Adenoidectomy. 8/6/09 Multiple hospital inpatient, DC summary, and ER records. Ear infection, tonsillectomy, adenoidectomy. Recent URI. PMH: Pharyngitis. OM. Diarhea. HSV1. Hand pain. weight gain. Dysthymic disorder . Ear tubes. Family hx of CMT.
Allergies:
Diagnostic Lab Data: Spinal tap, there was protein in the spinal fluid. 8/6/09 Multiple hospital inpatient, DC summary, and ER records. LABS and DIAGNOSTICS: CBC - WBC 2.61 K/mm3 (L) Mono 14% (H). Urinalysis - protein trace, blood trace, WBC 6 /hpf (H), RBC 13 /hpf (H). CHEM - Glucose 122 mg/dL (H). CRP 1.030 mg/dL (H). Blood Culture - No Growth. Chest X-ray - Mild thoracolumbar dextroscoliosis. LABS and DIAGNOSTICS: CT Head - Normal. CBC - WBC 3.73 K/mm3 (L) HCT 34.8% (L) PLT 123 K/mm3 (L) PMN 17% (L) Band 14% (H) Lymph 59% (H) Lumbar Puncture - CSF Protein 86.0 mg/dL (H). CHEM - Glucose 100 mg/dL (H) Total Protein Serum 6.0 g/dL (L) Albumin Serum 3.3 g/dL (L) Alk Phos 191 U/L (H) AST 68 U/L (H) ALT 74 U/L (H). Numerous bacterial and viral serologies and cultures negative. LABS: Infectious Mono (+). X-ray Hips/Pelvis WNL. MRI w & w/o Contrast - Nonspecific Findings. MRI Cervical/Thoracic/Lumbar w & w/o Contrast - Lumbar nonspecific findings. CBC - RDW 14.5% (H) PMN 35% (H) Lymph 54% (H). CHEM - BUN 4 mg/dL (L) Albumin Serum 3.1 (L) CPK 36 U/L (L) Carnitine 28 umol/L (L). CSF - IgG 15.2 mg/dL (H) Albumin 87.2 mg/dL (H) Protein 142.0 mg/dL (H). LABS and DIAGNOSTICS: CBC - RDW 14.3% (H). CHEM - Potassium 3.3 mEq/L (L) Glucose 100 mg/dL (H) Creatine 0.43 mg/dL (L). Labs: LFTs elevated. CSF protein increased. MRI brain WNL. CXR WNL. Nerve conduction studies abnormal. CSF IgG (H) 15.2. CSF protein 148. CSF Albumin (H) 87.2. Serum Albumin (L) 3.1, CBC WNL. Head CT (-). Monospot (+).
CDC 'Split Type': WAES0907USA01998

Write-up: Information has been received from a consumer concerning a 14 years old female with a history of tubes in ears when little and adenoids removed at age 2 years old and no drug reactions who on 13-NOV-2007 was vaccinated with the first dose of GARDASIL. There was no concomitant medication. The patient received the 2nd dose of GARDASIL on 16-JAN-2008 and the 3rd dose of GARDASIL on 23-MAY-2008. At the beginning of February 2009, the patient experienced weakness, pain, tiredness, terrible leg pain, shortness of breath, muscle weakness, every now and then the stomach bothers her, fever, and headache. The patient had been seen in the office and hospitalized. The patient has been in and out of the hospital. The unspecified physicians at the hospital thought the patient had Guillain Barre but later determined it is not. Two spinal taps, 3 CT scans, MRI, numerous X-rays and blood panels were performed. The results showed that there was protein in the spinal fluid. The patient is better but every now and then there is muscle weakness and joint pain throughout both arms, both legs and both feet. The patient was homebound for the rest of the school year and missed school from February to March in 2009. The patient was at the hospital with 17 different physicians. Weakness, pain, tiredness, terrible leg pain, shortness of breath, muscle weakness, stomach bothers her, fever, headache and joint pain throughout both arms, legs and feet were considered to be disabling and immediately life-threatening. Follow-up information has been received from a medical assistant concerning a 14 years old female who on 13-NOV-2007 was vaccinated with the first dose of GARDASIL (lot# 657737/0522U). The patient received the 2nd dose of GARDASIL (lot# 657737/0522U) on 16-JAN-2008 and the 3rd dose of GARDASIL (lot# 658094/0524U) on 23-MAY-2008. No other vaccines were administered at the time of the GARDASIL dose. A lot check has been initiated. Additional information has been requested. 7/24/09 MR received from PCP from 11/2007 to 4/13/09. In for sick visit 11/13/07 with c/o sore throat. DX: Fever HPV vax #1 given. Returned 12/7/07 with c/o back pain, body aches. Had been moving heavy boxes. DX: Pain Elbow. Shoulder Joint pain. PT had UA and dx with UTI. Returned 1/16/08 with c/o R ear pain. R TM bulging. DX: OM HPV#2 given. Several OVs for sore throat cough.DX: Pharyngitis, Acute. 3rd HPV 5/23/08 Continued ear pain with multiple visits. Knee pain 10/2008. Several ER visits for fever, dehydration, leg pain and swelling 3/2009. Later H/A. DX: Lymphadenopathy, H/A. Mononucleosis, infectious. Hospital f/u 4/3/09 for weakness and paresthesias. DX: Weight loss. GBS. Parent report 4/13/09 that pt has been falling a lot and has tingling in feet. To F/U with neurologist. 7/22/09 Partial hospital record rec''d for DOS 3/25-28/09 with D/C DX: Charcot Marie Tooth and 5/14-09 with same. Pt presented with worsening neck pain which radiates to fingers, L hip pain which radiates to toes, weakness, numbness of feet, . Recently hospitalized for GBS vs Charcot-Marie-Tooth Disease. Recent 18 lb weight loss. PE (+) stumbling gait, (+) Romberg, decreased reflexes. Labs: LFTs elevated. CSF protein increased. MRI brain WNL. CXR WNL. Nerve conduction studies abnormal. CSF IgG (H) 15.2. CSF protein 148. CSF Albumin (H) 87.2. Serum Albumin (L) 3.1, CBC WNL. Head CT (-). Monospot (+). 8/6/09 Multiple hospital inpatient, DC summary, and ER records. ER DOS 3/6/09. Assessment: Acute febrile illness, Viral syndrome, Proteinuria, leukopenia. Patient presents with fever, shortness of breath, bilateral ear pain. Bilateral leg pain, numbness, and tingling from knee to bottom of feet. Does not feel good. Decrease in appetite. Swelling in feet and legs. Fatigue. Blurred vision and seeing spots. ER DOS 3/10/09 - 3/11/09 Assessment: Acute febrile illness, fever with meningeal signs, increased liver function tests, Bandemia. Thrombocytopenia, hyperglycemia, impacted molar. Patient presents with continued fever. Pain right leg, numbness and tingling feet. Right ear ''draining yellow''. Feels swollen ''all over''. Headache and discomfort upper back. Neck stiff. ER / Inpatient DOS 3/24/09 to 3/28/09 Assessment: Fever, joint pain, headache Patient presented with fever. Pain in joints and weakness in lower legs. Knees ''give out''. Headache with photophobia. Pain on back of neck. Min reflexes, abnormal Rombergs, stumbling, falling, inability to run. Legs tingling. Rash. ER / Medical Observation DOS 5/13/09 - 5/14/09 Assessment: Paresthesias, joint swelling, recent history of Guillain-Barre syndrome. Charcot Marie Tooth. Patient presents again with weakness, body pain and fever, jaw pain, joint pain and swelling. Burning on urination. Weight loss, photophobia, neck pain. Areflexic. Wobbles in Rhomberg test. 9/22/09 ICD-9 codes received: 356.1, 357.0, 075, 781.3


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