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Administered by: Other Purchased by: Other
Life Threatening? Yes
Write-up: Case received from non-healthcare professional via Health Authorities on 06-Aug-2014 under the reference number SE-MPA-2014-004499 from Sanofi Pasteur MSD (reference # SE-1577272925-E2014-07010) on 08-AUG-2014. The primary reproter was a relative to the patient. A 12-year old female patient had received an unspecified dose of GARDASIL, (batch number not reported) via not reported route of administration in not reported site of administration on 20-Jan-2013 and later on 25-Jan-2013 she developed urticaria, and on 26-Jan-2013 lip swelling, tongue swelling and angioedema. The patient developed urticaria all over the body 5 days post vaccination and the day after swollen tongue and lips. Was treated with FRIAZYR (also reported as a suspect therapy) and adrenaline at hospital. The reporter writes that she has now had hereditary angioedema (HAE) for one and a half year and that this reaction has triggered HAE. No information on medical history reported, but it is stated in the report that the patient has received 2 doses of GARDASIL. However, it is not stated whether she has reacted on both or just one of the vaccinations. At the time of reporting, the patient had not recovered. According to the health authority, the reactions were possibly related to vaccination. According to clinician at MPA, hereditary angioedema should not be coded. The company decided to follow the coding of the HA. The HA report was assessed as serious due to hospitalisation, disabling and life threatening (although not further specified).
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