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Life Threatening? No
Write-up: Information has been received from Sanofi Pasteur [MFR # E2014-02871] on 28-MAR-2014. Case received from a health professional via the Health Authorities on 28-Mar-2014 under the reference DK-DKMA-ADR 22481236 and DK-DK-DKMA-EFO8608. Case us medically confirmed. Primary source was a physician. This case is linked to E2013-10742 as the patient was diagnosed with POTS at hospital post vaccination. A 14-year-old female patient (weight 55 kg, height 162 cm) with a medical history of asthma received the third dose of GARDASIL (batch no. unknown) via intramuscular route into not reported site of administration on 15-Apr-2009. On 15-Oct-2009, the patient developed POTS, extreme fatigue and nausea. The patient was very tired and had ability to become tired. The first year (correlation not specified, but probably post-vaccination) the patient was very nauseous. On 15-Dec-2009, the patient developed syncope. On an unspecified date, the patient also developed loss of consciousness/blackouts, frequent near faintings and was dizzy. The patient had only a few occasions of short-term syncopes and other times long-term loss of consciousness. Due to medical treatment (not specified) the symptoms improved. The patient had been hospitalised many times after blackouts - probably in neurological ward most times and had been extensively investigated (not specified). During tilt-table test POTS was diagnosed. The HA has contacted the patient''s physician for vaccination dates and batch numbers on all vaccines, but these are unknown. No other vaccines were given. Previous doses of GARDASIL were given via not reported route and administration site on 22-Oct-2008 (D1, batch no. unknown) and on an unspecified date (D2, batch no. unknown). At the time of reporting, the patient had not recovered from POTS and extreme fatigue and was recovering from syncope and nausea. The outcome of all other events was unknown.
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