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Administered by: Other Purchased by: Other
Life Threatening? Yes
Write-up: Information has been received from via Sanofi Pasteur MSD (MFR control #: IE-1577272925-2016011418) on 10-NOV-2016. This report was received from the RA on 08-Nov-2016 under reference number IE-HPRA-2016-028294. Case was received from a consumer/other non health professional concerning a female adolescent patient of unknown age who received dose one of GARDASIL (batch number NP26080, expiration date: 31-MAR-2013) on 20-Sep-2010 and dose two of GARDASIL (batch number G005669, lot number NM26350, expiration date: 31-JUL-2013) on 13-Mar-2012. The patient received concomitant administration of ELTROXIN, hydrocortisone (generic) and YASMIN and salt tablet on an unknown date. The patient experienced chronic fatigue, autoimmune disease, thyroid failure, ovarian failure and adrenal failure/Addison''s disease on an unknown date. The reporter indicated that the patient''s symptoms have gotten worse in the past 5 years and she was diagnosed with Addison''s disease. The reporter added that due to the lack of gland function the patient was at a life threatening stage. Corrective treatment included ELTROXIN, hydrocortisone (generic) and YASMIN and salt tablet. At the time of reporting the patient''s symptoms were persisting. The reporter added that the patient has no quality of life and her symptoms are affecting her school work and her past times are no longer possible. The patient''s outcome was reported as Not Recovered/Not Resolved. The reporter assessed the causal relationship: between Chronic fatigue and GARDASIL as Unknown; between Autoimmune disorder NOS and GARDASIL as Unknown; between Thyroid disorder and GARDASIL as Unknown; between Ovarian failure and GARDASIL as Unknown, between Addison''s disease and GARDASIL as Unknown.
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