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Administered by: Other Purchased by: Other
Life Threatening? No
Write-up: Information has been received from Sanofi Pasteur [manufacturer control # CH-1577272925-E2014-00139] on 08-JAN-2014. Case reported by a pharmacist to the Health Authorities on 08- Jan-2014 under the reference number 2013-06303. Case medically confirmed. A female patient born (weight: 63 kg; height not reported) had received a second dose of GARDASIL (batch number NH55610 and lot number 1693U) on 11-Dec-2009 and a third dose of GARDASIL (batch number NH55610 and lot number 1693U) on 30-Apr-2010, via intramuscular route (site of administratoin for both doses not reported). The patient''s medical history included menarche at 12 years old. The patient was non smoker. The first dose of GARDASIL (batch number NJ35180). The patient had no health problem until the end of 2009 and she was not taking any medications. No case of hidradenitis suppurativa was reported in the patient''s family. Since Jan-2012, the patient was taking a contraceptive pill with Ologyn (1 dosage form once daily). On an unspecified date, but at the latest in Christmas 2009, the patient developed cutaneous lesions: abcessed nodules between the breasts and on groin folds/genital area, associated with burn-like pains, whereas there was no lesions before Nov-2009. The lesions persisted and evolved into nodules in the breasts. A Verneuil disease (also called hidradenitis suppurativa or acne inversa) was diagnosed in 2012 by a dermatologist. On an unspecified date, but clearly exacerbated after the third GARDASIL injection on 30-Apr-2010, the patient developed headaches, heat intolerance and fatigue. At the time of reporting, the patient did not recover from fatigue and headaches, which partly responded to antalgic medications (paracetamol, ibuprofen). The patient did not completely recover from heat intolerance but slightly improvement occurred since 2010. Pain due to cutaneous abscesses and headaches was very pronounced and caused school absenteeism (around 3 to 5 days of absenteeism per month). The patient''s mother reported these symptoms to the pharmacist and made the link between her daughter''s symptoms and GARDASIL vaccination after seeing a TV show focused on a complaint initialized by a female patient in this country. This patient was diagnosed with multiple sclerosis which first developed after GARDASIL vaccination. Two cases of Veneuil disease were also reported on this occasion. The mother was very concerned for her daughter. A MRI brain performed on 15-Jul-2010 showed no abnormality. At time of reporting, the patient was recovering from heat intolerance and had not yet recovered from the other events. The Health Authority coded "Sweet gland disorder", "Abscess", "Headache", "Fatigue" and "Heat intolerance". The Company added "hidradenitis suppurativa" (reported diagnosis) as an additional event. According to the Health Authorities, the reactions were possibly related to the vaccination. The Health Authorities considered the case sa serious (disabling). Additional information is expected.
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