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Life Threatening? No
Write-up: Information ahs been received from Sanofi Pasteur MSD (MFR control number DK-1577272925-E2015-11315) on 21-DEC-2015. Case received from Health Care Professional via Health Authorities on 13-Oct-2015 under the reference number DK-DKMA-ADR 23128944 and DK-DKMA-WBS-0000835. The case is medically confirmed. The primary reporter was a physician. A female patient had received an unspecified dose of GARDASIL, (lot/batch number not reported) via not reported route of administration in unspecified site of administration on not reported date and later on not reported date, she developed headache. The reporter has only reported headache as the patient states that her own physician has reported. Own physician has not reported and it is expected a follow up report from the reporter. The case is serious due to seriousness criterion disability. No information on other vaccines or medications provided. No information on results of test and procedures provided. No information on medical history provided. At the time of reporting, the outcome was unknown. Follow up information received on 17-Dec-2015 from physician via HA. The HA received follow up information on 14Dec2015 from syncope center, hospital (DK-DKMA-WBS-0002026/DK-DKMA-ADR 23274781 - has not been sent out): Adverse reactions: Abdominal pain, blurred vision, cognitive function abnormal, dizziness, dry skin, fatigue, headache, light sensitivity to eye, menses regular with excessive bleeding, tics, voiding difficulty and POTS. The reporter does not have the vaccination dates, but according to the physician that referred the patient the first vaccine was given 15-Oct-2014. The patient describes that the first symptom was headache and that it started 14 days after the vaccination. Subsequently, the other reported adverse reactions developed. Tilt table test showed that the patient fulfills the diagnostic criteria for POTS. Criteria for diagnosis of 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). Added/changed: Start date (15-OCT-2014) and route of administration (i.m.) for GARDASIL added. Onset date for headache (29-OCT-2014) added, test added. Reactions added (all with outcome, not recovered, except POTS and near syncope which have the outcome unknown). This is a corrected report. This report was previously submitted with the incorrect Worldwide unique case identification number DK-1577272925-E2015-11315, and this new follow-up submission is to provide the correct identification number DK-DKMA-WBS-0000835, DK-1577272925-E2015-11315 is an existing case and is an E2B Report Duplicate of DK-DKMA-WBS-0000835, therefore this safety report is not being nullified, just updated to reflect correct Worldwide Unique identifier.
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