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Administered by: Other Purchased by: Other
Life Threatening? Yes
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
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