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Administered by: Other Purchased by: Other
Life Threatening? No
Write-up: Information has been received from Sanofi Pasteur MSD (SPM) (manufacturer control # 2016004793) on 29-APR-2016. NOTE TO AGENCY: Please do not return cases received from the Medicines Agency (MA) unless you received new information regarding the case. Please remember to use the worldwide unique case identification number for this case: DK-DKMA-WBS-0003228. Also, please not that information should not be deleted from the case (especially not the patient characteristics). Case received from a physician via health authority on 27-Apr-2016 under reference number DK-DKMA-WBS-0003228. A 12-year-old female adolescent patient received GARDASIL (batch/lot number and site of administration were unknown, Dose 1) via intramuscular route on 01-Mar-2011, GARDASIL (batch number and site of administration were unknown, Dose 2) via intramuscular rout eon 03-May-2011, GARDASIL (batch/lot number and site of administration were unknown, Dose 3) via intramuscular route on 31-Aug-2011. the patient experienced postural orthostatic tachycardia syndrome on an unknown date, hair loss on an unknown date, light sensitivity to eye on an unknown date, headache in 2011, dizziness on an unknown date, nausea on an unknown date and fatigue on an unknown date. Patient tell that symptoms debut within 6 months after 3 dose. She got severe headache and dizziness. Afterwards the other reported reactions. Until vaccination she describes her activity level as normal. As a consequence of her symptoms, she had in grade 7-9 a lot of absence. Tilt table test shows that she suffer from POTS. the reporter does not have batch number. Other medicines or vaccines: Unknown: Diagnostic criteria for POTS" Heart rate increases greater than or equal to 30 bpm from supine to standing (10 min) in the absence of orthostatic hypotension (decrease in BP greater than 20/10 mmHg). Symptoms worsen with standing and improved with recumbence. Symptoms last greater than or equal to 6 months. Absence of other overt cause of orthostatic symptoms or tachycardia (e.g., active bleeding, acute dehydration, medications). In addition, the Hospital uses further criterion in patients between 12-19 years; requires a heart rate increase of greater than 40 bpm to make the diagnosis, the reasons for this is that young people have a stronger physiological heart rate response when standing up. the additional criterion is used to avoid false positives. the patient''s outcome was reported as Not Recovered/Not Resolved for POTS, Light sensitivity to eye, fatigue, and recovering for headache, nausea and unknown for hair loss and dizziness.
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