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Life Threatening? No
Write-up: Information has been received from Sanofi Pasteur (MSD) (SPM) (manufacturer control # E2015-04601) as part of business agreement on 08-JAN-2016. Case received from health care professional via Health Authorities on 27-Apr-2015 under the reference number DK-DKMA-ADR 22965066 and DK-DKMA-EFO11783. The primary reporter was a physician. A 14 year old female patient (weight: 62 kg; height 167 cm) with a medical history of anxiety attack, had received dose 3 of GARDASIL, (batch number not reported) via i.m route of administration in unspecified site of administration on 10-Dec-2010 and later on 16-Mar-2012 she developed palpitations and unspecific malaise. The patient has previously received dose 1 and 2 of GARDASIL (batch numbers not reported) on 24-Mar-2010 and 27-May-2010. The patient experienced unspecific malaise and palpitations, in addition she feels discomfort during physical activity in connection with GARDASIL vaccine. No other medicines. The patient has been examined by a cardiologist without any signs of heart complications. At the time of reporting, the patient had not yet recovered. Follow up information received on 08-Oct-2015 from HA. The HA received follow up information on 16-Sep-2015 from the reporter, who is the patient''s physician at the request of Sanofi Pasteur MSD: The batch no. for the three vaccines cannot be informed as they are not noted in the medical records by the previous physician. The adverse reactions unwell and palpitations are unchanged. Follow up information received on 04Jan2015 from the HA. Case initially reported as non serious was upgraded to serious due to presence of serious events Postural orthostatic tachycardia syndrome, inappropriate sinus tachycardia, Palpitation and malaise with the seriousness criteria disabling. The HA received follow up (duplicate ADR 23278260 merged with this master) on 16Dec2015 from physician at the hospital: Adverse events added/changed by the HA were Postural orthostatic tachycardia syndrome and inappropriate sinus tachycardia. Disabling was added as the seriousness criterion and the case is upgraded to serious. A tilt table test showed that the patient has in an already lying resting position a heart rate$g 100 bmp and when standing heart rate of 125 to 30 bmp and very labile and at times with very low blood pressure which corresponds with the usual postural discomfort - but not normal orthostatic hypotension. The patient had been examined by a Cardiologist without any signs of heart problems. The outcome of the newly reported events was Not Recovered/Not Resolved. This is a corrected report. This report was previously submitted with the incorrect unique case identification number "DK-1577272925-E2015-04601", and this new follow-up submission is to provide the correct identification number "DK-DKMA-EFO11783:. "DK-1577272925-E2015-04601", is an existing case and is an E2B Report Duplicate of DK-DKMA-EFO11783". Therefore this safety report is not being nullified, just update to reflect correct Worldwide Unique Identifier.
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