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Life Threatening? No
Write-up: Information has been received from Sanofi Pasteur MSD (MFR number# DK-1577272925-2015001270) on 21-DEC-2015. Case received from a physician via HA on 18-DEC-2015 under the reference number DK-DKMA-ADR 23278261 and DK-DKMA-WBS-0002141. A 12-year-old female adolescent patient received GARDASIL, batch number unknown via intramuscular route on an unknown date. The patient experienced Postural orthostatic tachycardia syndrome on 02-FEB-2012, Headache on an unknown date, Dizziness on an unknown date, Palpitations on an unknown date, Nausea on an unknown date, abdominal pain on an unknown date, Fatigue extreme on an unknown date, Muscle spasms on an unknown date, Muscular weakness on an unknown date and Influenza-like symptoms on an unknown date. The family cannot remember the vaccination dates exactly, but remembers that the patient became immediately after the 2nd vaccine experienced tiredness, dizziness and influenza-like symptoms. The symptoms did not disappear completely - and the other symptoms developed. Fulfills, at tilt table test, criteria for POTS and syncope. The syncope center uses the following criteria to confirm the diagnosis 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, an additional criterion was used in patients between 12-19 years old: require a pulse increase greater than 40 bpm to confirm the diagnosis, based on that young people have a greater physiological pulse response upon standing up. This additional criterion was used to avoid false positives. Unknown whether there were other vaccines or medications. At the time of reporting, the outcome was unknown for the reactions muscle spasms and muscular weakness. The patient had not recovered from the other reactions.
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