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Administered by: Other Purchased by: Other
Life Threatening? No
Write-up: This spontaneous report as received from a physician refers to a 16 year old female patient. On 30-AUG-2011 the patient was vaccinated with GARDASIL, 0.5 ml, intramuscular. The dose number, the lot number and expiration date of the vaccine, the route of administration and anatomical location of the vaccination were not reported. On 10-SEP-2011, reported as 11 days after the date of vaccination the patient experienced celiac disease (disability, medically significant upon internal review), tripping down the stairs because her legs were so weak (disability), muscle pain (disability), extreme fatigue (disability), myasthenia gravis (disability, medically significant upon internal review) and being so weak that she had issue lifting her arms (disability). Disability was reported as serious criterion, the event(s) to which this referred however were not specified. Treatment for the myasthenia gravis included MESTINON, IVIG and Prednisone. The outcome of celiac disease, tripping down the stairs, muscle pain, extreme fatigue and myasthenia gravis was reported as not recovered/not resolved. The physician reported that all adverse effects were progressing. No causality statement was reported for any of the events in relation to GARDASIL. Additional information has been requested.
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