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Administered by: Other Purchased by: Other
Life Threatening? No
Write-up: Information has been received from Sanofi Pasteur MSD(SPM) with (MFR# DK-1577272925-2015000438) on 02-MAR-2016. Case received from a consumer/other non health professional via HA on 12-NOV-2015 under the reference DK-DKMA-WBS-0001616 and DK-DKMA-ADR 23225253. A 12-year-old female adolescent patient received GARDASIL (batch number unknown, Dose 1) on 09-APR-2010, GARDASIL (batch number unknown) on 01-NOV-2010. The patient experienced chronic tiredness in 2011, Joint pain in 2011, Muscle pain in 2011, Dizziness in 2011, Palpitation in 2011, Nausea in 2011, Headache in 2011 and Concentration impairment in 2011. The patient has not been treated for the adverse reactions. The patient has not been hospitalized due to the adverse reactions. The patient''s outcome was reported as Not Recovered/Not Resolved. Follow up information received from HA on 29-FEB-2016. The HA received a duplicate from the patient''s physician on 22-FEB-2016. The duplicate has not been sent to agency before merging to this master case. Adverse reactions: Hyperventilation, movement problems, pale skin, general feeling of discomfort or illness, hair loss, chills, nausea, joint pain, muscle pain, sudden and severe back pain, red spots on skin/redness on the skin, pain in body, pain in joints, pain in legs and stomach, sleeplessness, sleep problems, dizziness, dry skin, dry hair, rash on body, abnormal tiredness, increased sweating, increased urination. Other vaccines: No. Other medication: No. Added to the case: New adverse reactions are added, all with outcome: Not Recovered/resolved (Hyperventilation in DEC-2012, movement problems on an unknown date, Pale skin on an unknown date, General feeling of discomfort or illness on an unknown date, Hair loss on an unknown date, Chills on an unknown date, Sudden and severe back pain on an unknown date, red spots of skin/redness on the skin on an unknown date, pain in body on an unknown date, Pain in legs on an unknown date, Pain in stomach on an unknown date, Sleeplessness on an unknown date, Sleep problems on an unknown date, Dry skin on an unknown date, Dry hair on an unknown date, Rash on body on an unknown date, Increased sweating on an unknown date, Increased urination on an unknown date and Loss of energy in DEC-2011). The case is upgraded to serious (disabling). The case is now medically confirmed. Date of vaccination for the 2nd Dose (23Jun2010), Route of administration (intramuscular), and batch number for dose 1 (NL 12890, lot# 1334X, expiry: 17-OCT-2011) added.
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