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Life Threatening? No
Write-up: Information has been received from a physician concerning a 16 year old male patient with cefaclor allergy and no pertinent medical history who on 18-AUG-2011 was intramuscularly vaccinated in the right arm with 0.5 mL of the first dose of GARDASIL (Lot# 667165/1167Z, expiration: unknown). Secondary suspect vaccine included VARIVAX (Merck). Concomitant therapy included HAVRIX. Physician reported that the day after administration of GARDASIL the patient experienced pain in his right arm, on 19-AUG-2011. On 20-AUG-2011 the pain became worse. On 21-AUG-2011 the patient also experienced general malaise, muscle spasms, dystonic movements, and severe pain in his arm. On 22-AUG-2011 the patient had to leave school early because he was experiencing muscle spasms of his arms, neck, back, and legs. On 23-AUG-2011 the patient slept all day. On 24-AUG-2011 the patient began having severe muscle spasms of the neck and torso. He was examined in the emergency department. Physician reported that the patient was treated with BENADRYL and ATIVAN intravenously for tonic/clonic movements and tremors. Movements resolved 15 minutes after ATIVAN was administered but started one hour later. Second dose of ATIVAN was administered and patient was admitted to the hospital. On 24-AUG-2011 the patient experienced dystonic movements and severe pain every 6 hours. Patient was treated with ATIVAN intravenously and was still currently in the hospital. He was still experiencing dystonic movements. The movements were of shorter duration (5-10 minutes) and decreased frequency, but with same intensity. The morning of 25-AUG-2011 his legs were "drawing up" and he could not walk. A CBC was performed with normal limits as result, also a blood glucose was performed with 145 as result. The patient sought medical attention via hospital. At the time of reporting the patient was recovering. Pain in right arm, general malaise, muscle spasms, dystonic movements, muscle spasms of arms, neck, back and legs, slept all day, severe muscle spasms of neck and torso, tonic/clonic movements, tremors, dystonic movements, drawing up and could not walk were considered to be disabling. Additional information has been requested.
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