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Write-up: Information has been received from Sanofi Pasteur (MSD) (case report number DK-1577272925-E2015-07814) as a part of a business agreement on 18-FEB-2016. Case received from a consumer via health authority on 23-Jun-2015 under the reference number DK-DKMA-ADR 22991018. The case is not medically confirmed. The primary reporter was a patient. A 12 year-old female patient (weight: 40 kg; height: 165 cm) had received the first and second dose of GARDASIL (batch/lot number: D1: J010618, expiration date 29-FEB-2016, D2: lot reported as J011748, expiration date not provided) via I.M route of administration in unspecified site of administration on 07-Aug-2014 and 20-Feb-2015. On unspecified days in Sep-2014, she developed headache, migraine, malaise, tiredness, sleeplessness, sad, introverted, nausea, vomiting, lumbar pain and fever. On unspecified date in 2014, she experienced extreme menstrual pain. On unspecified day in Feb-2015, she developed lymph node in right arm pit. On unspecified day in Apr-2015, she developed dizziness. On 19-May-2015, she could not walk/bend legs (cessation date: 19-May-2015). On 13-May-2015, she developed lymph node in left breast that hurts. The patient has received the 2 dose program. The extreme menstrual pain comes every month and causes a sick day when the patient has to take pain alleviating medications. (not further specified). No information on other vaccines. The patient has been scanned and has taken blood tests. It is informed that the tests did not show anything. (not further specified) the patient had no relevant medical history. At the time of reporting, the patient had recovered from could not walk/bend legs (cessation date: 19-May-2015) and the patient was recovering from lymph node in left breast that hurts. The patient had not recovered from the remaining adverse reactions. Follow up information received from health authority on 16-Feb-2016 (ref: DK-1577272925-E2015-07814). The HA has received a duplicate from syncope center (DK-DKMA-WBS-0002719 / DK-DKMA-ADR 23355750). Reported as Disabling. Narrative from the duplicate. The patient has herself reported symptoms as possible reactions related to HPV vaccine. The physician medical confirms and added the diagnosis POTS: During active position change a raise in the heart rate, from 67 to 121 bpm with a maximal heart rate of 133 bpm. Coincident with known orthostatic discomfort. During tilt table test a raise in heart rate, from 74 to 112 with max heart rate of 125 bpm. Fulfills the diagnostic criteria for POTS during active position change but no fully during tilt table test. POTS added as reaction. The following criteria has been used 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 improve 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 patient''s 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. Case correction for reporting purposes only (19FEB2016): This is a corrected report. This report was previously submitted with the incorrect unique case identification number DK-1577272925-E2015-07814, and this new follow-up submission is to provide the correct identification number DK-DKMA-ADR 22991018. DK-1577272925-E2015-07814 is an existing case and is maintained within safety report DK-DKMA-ADR 22991018.
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