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Administered by: Other Purchased by: Other
Life Threatening? No
Write-up: Information has been received from Sanofi Pasteur MSD (SPM) (MFR control number DK-1577272925-2016008235) on 18-AUG-2016. Case received from a physician via HA on 15-AUG-2016. A 12-year-old female adolescent patient received GARDASIL, (batch number LOT UNK, Dose 1) via intramuscular route on 01-DEC-2010, GARDASIL, (batch number LOT UNK, Dose 2) via intramuscular route on 16-FEB-2011, GARDASIL, (batch number LOT UNK, Dose 3) via intramuscular route on 04-AUG-2011. The patient experienced anxiety, suicidal/suicidal thoughts, dizziness, palpitation, nausea, abdominal pain, skin disorder, shortness of breath, sleep disorder, weakness of legs, weakness of arms, shaking of hands, obstipation, diarrhea, and a lot of absence from 9th grade and dropped out of 10th grade on an unknown date. Process of the adverse events: patient informs that the first symptoms occurred in between the first and second vaccination - she then debuted with anxiety and suicidal thoughts. Subsequently the rest of the symptoms occurred. Up until the vaccinations the patient played handball 1 time a week. As a consequence of the symptoms the patient has been having a lot of absence from 9th grade and dropped out of 10th grade. She has also been admitted to the child psychiatry unit. Tilt table test shows that she does not fulfill the diagnostic criteria for Postural Orthostatic Tachycardia Syndrome. Other vaccines or medications: unknown. The patient was admitted to hospital on an unspecified date. Additional investigations included tilt table test does not fulfill POTS criteria on an unknown date. The patient''s outcome was reported as not recovered/not resolved.
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