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Administered by: Other Purchased by: Other
Life Threatening? No
Write-up: Initial and follow-up information has been received from a consumer concerning a 13 year old female with no pertinent medical history and no drug reactions/allergies who on 13-MAR-2008, 23-MAY-2008 and 26-SEP-2008 was vaccinated with the first, second and third dose of GARDASIL respectively (lot # 659182/1757U, 660391/0063X and 659184/0843X), injection. Concomitant therapy included ibuprofen and AMITRIPTYLIN. In September 2008, the mother stated her daughter experienced chest pain, fever, nausea, muscle stiffness, headaches, stomach problem, and when she was not really feeling well in her pupils became "dilated", while on GARDASIL. She did not go to school and was not active because she could not even get out of bed. The patient had had chest X-rays, EEG''S, CAT Scans, sleep studies, and blood work done which all came back negative. The consumer also reported that the patient was an avid dancer before getting GARDASIL and she could not even get out of bed, "I had taken her to specialist and other physicians and no one can figure out what is wrong". The patient''s outcome was not recovered. On unspecified date, the patient sought unspecified medical attention. The nurse stated that the patient''s mother consented to come to the office to sign the Consent for the Release of Medical Information concerning the patient, and she would call back when the patient''s mother signed the Consent Form about if the patient was able to attend school. Upon internal review she doesn''t go to school and isn''t active because she can''t even get out of bed was considered to be disabling. This is one of several reports concerning the same source. A lot check has been initiated. Additional information has been requested. 5/18/09 Received vaccine & PCP office records of 2/20-3/23/2009. FINAL DX: fatigue syndrome Records reveal patient w/intermittent low grade fever, fatigue, HA, abd pain, chest pain since approx 9/08. No longer able to participate in dance & missed some days of school. Referred to Neuro, Cardio & ID. Seen in ER for passing out. 6/1/09 Neurology consultation records received DOS 4/14/09. FINAL DIAGNOSIS: None provided. Post vaccination: Fevers, injuries, fatigue, headache, migratory aches and pains. Stomach pains, chest pain. Episodes of syncope, fell and hit head on the floor. Dizziness, short of breath, disturbed sleep, snores. Polysomnogram, 24 hour EEG to be performed. Immunology or infectious disease consult recommended. 7/17/09 Pediatric infectious disease consultant records received DOS 6/25/09. Assessment: Symptoms most likely related to Rheumatological condition. Patient presents with intermittent fever, fatigue, chest pain, abdominal pain, headache and myalgia since Sept. ''08 and fainting since March ''09. Myalgia of arms and legs. Knee pain. Postural hypotension. Unresponsive during fainting spells. Weight gain.
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