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Administered by: Other Purchased by: Other
Life Threatening? No
Write-up: Information has been received via Sanofi Pasteur MSD (Manufacturer control # E2015-12802) on 13-NOV-2015, as a part of business agreement. Case received from Health Care Professional via Health Authorities on 11-Nov-2015, under the reference number DK-DKMA-ADR 23224114 and DK-DKMA-WBS-0001611. The case is medically confirmed. The primary reporter was a physician. A 13 years-old female patient (weight: 54: kg; height: 174 cm) with a medical history of suspected asthma, had received the first primary dose of GARDASIL, lot/batch number reported as NL48770 via intramuscular route of administration in unspecified site of administration on 15-Dec-2010, and later on 15-Jan-2011, she developed chest pressure at physical activity, shaking, inner restlessness. On 15-Feb-2011, the patient developed malaise and nausea. The patient has been under investigation by physician several times. No reasons found. It is a bit unclear to the reporter exactly when the problems started, but the family remembers it being after the first GARDASIL vaccination (approximately as stated). The case is serious due to seriousness criterion disability. The patient had received concomitant injection of PRIORIX via unspecified route of administration in unspecified site of administration on 20-DEC-2010. No other medication. Patient has undergone blood tests and lung function. Blood tests were normal. Lung function (peakflow variation gives suspicion of asthma). At the time of reporting, the patient had not recovered.
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