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Administered by: Other Purchased by: Other
Life Threatening? No
Write-up: Information has been received from Sanofi Pasteur MSD [SE-1577272925-2016003520] on 21-APR-2016. Case received from physician via company representative on 01-APR-2016. Company representative had a call from a physician at a pediatric clinic. A 11-year-old female child patient received GARDASIL (batch number lot not rep) in October 2015. The patient experienced tiredness on an unknown date and Tingling sensation in the arm on an unknown date. Company representative interpreted that the girl had gone through 2 evaluations (?) without any findings. The physician will come back to us with more information. The patient''s outcome was reported as unknown. Follow up information was received from physician on 12-APR-2016: Received the first dose of GARDASIL in November 2015. After approximately 5 weeks she had a cold with tiredness, myalgia, fever and an upper respiratory tract infection. After that she did not recover, she has remaining symptoms such as pain in the whole body, especially the face. Feeling swollen. Not numb. Evaluated by agency which did not find anything. Sinusitis excluded. She is very tired, pale and experiences dizziness now and then. She hasn''t been in school since. She tried a couple of hours this week with help from Cognitive Behavioral Therapy. More evaluations has been conducted both at the pediatric clinic and at the hospital. There are no findings but infections, tumors, rheumatic diseases, hypothyroidism, malignancies have been excluded. Allergy tests are have been taken and the results are expected by the end of this week. She was very healthy before the vaccination. Company contacted the physician on 18-APR-2016 regarding the results of the allergy test. The physician had not yet received any results and had not seen the girl since the last contact. The physician has an appointment with the girl in two weeks, An action item has been created to contact the physician again after the appointment. Added/Changed: Case has been updates from non-serious to serious due to disability (long period of absence from school), date of birth added, date of vaccination changed, events added (cold, myalgia, fever, upper respiratory tract infection, general body pain, swollen, pale, dizziness, absent from school). The seriousness of the events Tiredness sensation in the arm, was updated to disability. The patient also experienced cold, myalgia, fever, upper respiratory tract infection, pain in the whole body, especially the face, feeling swollen, pale, dizziness now and then and absent from school on an unknown date. The reporter considered the seriousness of these events as disability. The patient''s outcome was reported as unknown.
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