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Administered by: Other Purchased by: Other
Life Threatening? No
Write-up: Information has been received from Sanofi Pasteur MSD (manufacturer control # DK-1577272925-2016007082) on 11-JUL-2016. Case received from a consumer/other non health professional on 05-Jul-2016. A 14-year-old adolescent patient received GARDASIL (batch number lot not rep, Dose 1) via intramuscular route on 10-Dec-2008, GARDASIL (batch number lot not rep, Dose 2) via intramuscular route on 24-Feb-2009, GARDASIL (batch number NH52670, Dose 3) via intramuscular route on 06-Jul-2009. The patient experienced daily headache, before the patient played football and started to train fitness, fatigue, feeling bloated, near syncopes, nausea, palpitations, sleep difficult, dizziness and light sensitivity to eyes on an unknown date. Narrative: daily headaches for 5 years. The patient has been following treatment for adverse reaction: Zolmitriptan, Diclofenac rapid, Codeine, Paracetamol, Klorzoxazon, KODIMAGNYL, PAMOL, Klorzoxazon. Other: RIGEVIDON, Contraceptive Pill. Allergy: ALNOK, ELIDEL Cream, Cream Hydrocortisone. Tested treatments: Acupuncture, pain clinic and massage sacral therapy. 24Oct2014: The dermatologist due to eczema. 06Jan2015: prick test, showing allergies for dogs and cats. 18Nov2014: physiotherapy, relaxation plus massage. The patient is continuing treatment. 25Nov2014 to 10Sep2015: Neurologist. 14Dec2014: MRI 02Jan2015 then Neurosurgery Outpatient 04Feb2015. 05Jan2015: Psychologist then conversation courses to 22Jan2015. Doctors examination: 28Jan, 24Feb and 26Feb. The patient has not been hospitalized due to adverse reaction. Other medicines: No. The patient''s outcome was reported as Not Recovered/Not Resolved. Notes: Before the vaccine the patient was a healthy girl who did a lot of sports and hardly ever ate medicine. Now the patient goes to a lot of treatments and have made a lot of examinations. In high school the patient struggled a lot with concentration and fatigue as she with the daily headaches had difficulty getting through the day. The patient is still suffering from headaches, but since it has become chronic, the patient has learned to get through the day with it. Follow-Up (version 002): Duplicate received on 07Jul2016 (DK-DKMA-WBS-0003985 / DK-DKMA-ADR 23556491) via HA. The duplicate is detected before it was sent out and is added as duplicate in this master case. Narrative of the duplicate: Side Effects: bloating, dizziness, eyes sensitive to sunlight, fatigue, headache, nausea, near fainting, palpitations, sleep difficulty. History Around side effect: Onset of symptoms after 3rd vaccine which the patient experiences headaches that started creeping, but over time headaches has been on a daily basis. Subsequently, it is for the other reported symptoms. By tilting table test at examination the patient does not fulfill diagnostic criteria for POTS. Patient describes a greater absenteeism in 3rd grade because of the headache. The patient was up to the vaccine time a very active girl who played soccer and started to train fitness - where she went several times a week. The headache limits her daily life. Other Vaccines: Do not know. Other Medicines: Do not know. Regulatory authority comments: The report is now medically confirmed and the physician upgraded to Disabling. Added Side effects: Bloating, Dizziness, Eyes sensitive to sunlight, Fatigue, Nausea, Near fainting, Palpitations, Sleep difficult, Exercise capacity decreased, Activities of daily living impaired.
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