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Life Threatening? No
Write-up: Information has been received from Sanofi Pasteur MSD (SPM) (MFR control number DK-1577272925-2016002357) on 15-MAR-2016. Case received from a physician on 11-MAR-2016. A female adolescent patient of unknown age received GARDASIL (batch/lot number lot not rep, Dose 1) on an unknown date. the patient experienced Postural orthostatic tachycardia syndrome on an unknown date, frequent near fainting on an unknown date and Daily orthostatic intolerance on an unknown date. Symptoms start after dose 1 of vaccine. the patient fulfills the criteria for POTS. A tilt table test shows a pulse increase 59 -$g 100 bpm with maximal heart frequency at 116 bpm and severe and known discomfort. In addition, frequent near fainting and severe daily orthostatic intolerance. Diagnostic criteria for POTS; Hear rate increase 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 additional criterion with patients between 12-19 years old: required a heart rate increase of greater than 40 bpm to make the diagnosis, on the grounds that young people have a stronger physiological heart rate response to standing up. the use of any additional criterion to avoid false positives. the patient was admitted to hospital on an unspecified date. the patient''s outcome was reported as Not Recovered/Not resolved. Note to agency: Please do not return cases received from the Medicines Agency (DKMA) unless you received new information regarding the case. Please remember to use the worldwide unique case identification number for this case: DK-DKMA-WBS-0002735. Also, please not that information should not be deleted from the case (especially not the Patient Characteristics).
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