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Life Threatening? No
Write-up: Information has been received from Sanofi Pasteur MSD (MFR control number (DK-1577272925-2016001079) on 21-APR-2016. Case received from a consumer/other non health professional via HA on 09-FEB-2016. An 11-year-old female child patient received GARDASIL (batch number lot not rep) via intramuscular route in Aug-2013. The patient experienced daily headaches in 2014, stomach pain in 2013, Nausea in 2013, Dizziness in 2013, fainting with convulsions and confusion at awakening in 2015, pronounced tiredness in 2013, Neck pain in 2014, Knee pain in 2013, Irregular menstruations in 2014, Pale skin in 2013, Difficulty breathing in 2013, low blood sugar in 2015, Hypertension in 2015. Other medication: No. The patient had a medical history of: -Asthma -Allergy to animal. Remarks: The patient was very active in sports and exercised several times a week before the vaccine. After the vaccination, the patient''s health was not good enough for physical activities, and she stopped practicing leisure activities a few months after the vaccination, due to tiredness, nausea and stomach pain. The patient''s outcome was reported as Not Recovered/Not Resolved. The HA has requested medical confirmation and is awaiting reply. FOLLOW-UP (version 002) received 19-APR-2016 from HA. The HA received the information 03-MAR-2016 from the patient''s physician at the behest of request for medical confirmation: The doctor confirms that the patient has experienced symptoms of exercise capacity Decreased, neck pain, tiredness, dizziness, fainting, headache and nausea. The doctor does not know whether the patient has experienced knee pain, pale skin, irregular menstrual cycle, hypertension, abdominal pain, Difficulty breathing, blood sugar Decreased, temporal Disorientation and cramps. The doctor answered "?" to whether or not this mean that the case of suspected adverse reactions are coupled to GARDASIL. The doctor can inform that the first dose was given 22-AUG-2013. Other vaccination dates and batch numbers are not known. The doctor informs the patient complain of headaches, nausea, neck pain, difficulty concentrating and fatigue and an increased need for sleep. Increased absenteeism from school has resulted in two reports and reduced physical activity and recreation. The patient is referred for further investigation at the medical clinic. Regulatory authority comment: Since the patient''s doctor has not decided whether she believes the case of suspected adverse reactions are coupled to GARDASIL or not, the matter is still not medically confirmed. The following information is added to the case on the basis of follow up: Severity criteria disability / incapacity. Start date for GARDASIL. Concentration impaired, sleep excessive and impaired work ability during Reactions. Relevant information under Test. PULMICORT Turbuhaler under Other drugs. The following information is changed in the case on the basis of follow-up: The case has been upgraded to serious.
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