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Administered by: Other Purchased by: Other
Life Threatening? No
Write-up: Information has been received from Sanofi Pasteur MSD (MFR control number DK-1577272925-2016006524) on 24-JUN-2016. Case received from a physician via HA on 21-JUN-2016 under reference DK-DKMA-ADR 23529268. A 12-year-old female adolescent patient received GARDASIL (batch number lot unk) via intramuscular route on 10-NOV-2011, GARDASIL (batch number lot unk) via intramuscular route on 08-FEB-2012. The patient experienced Hives, Asthma, Sjoegren''s syndrome, Pityriasis rosea, Headache, Palpitation, Acid reflux (oesophageal), Abdominal pain, Voiding difficulty, Fatigue, Sleep difficult, Weakness of limbs, Immunocompromised, Temperature regulation disorder, Wrist pain, Quit playing football completely and A lot of absence, has a hard time in school on an unknown date. Process around the adverse event: Patient informs about symptom onset after the first vaccination. She experiences hives, is diagnosed with asthma, Sjogren''s syndrome and pityriasis rosea. Subsequently the other symptoms occurs. Up until the vaccinations the patient played football 6 times a week of 1.5 hours a time. As a consequence of her symptoms the patient has quit football completely, she has a hard time in school since everything requires more energy of her. She has also a lot of absence from school e.g. due to hospital examinations/checkups that she has to go to. Other vaccines: unknown. Tilt table test shows that she does not fulfill diagnostic criteria for Postural Orthostatic Tachycardia Syndrome. The patient was admitted to hospital on an unspecified date. The patient''s out was reported as Not Recovered/Not Resolved.
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