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Life Threatening? No
Write-up: Case of adverse event received via Sanofi Pasteur MSD from a health care professional via company representative on 14-Nov-2013. The primary reporter was a physician. Case is medically confirmed. A 12 year-old female patient, had received the second dose of GARDASIL, (batch number not reported) via not reported route of administration in not reported site of administration on 21-AUG-2013 and later on 2-3 post-vaccination, she developed severe periodic headaches 5-8 time daily. The patient has not been in school since. The patient had previously received the primary dose of GARDASIL on a non-specified date during the summer of 2013 (batch number not reported) via not reported route in not reported site of administration. No other medical history reported. At the time of reporting, the patient had not recovered. Follow up information received from a health care professional via Health Authorities on 19-Nov-2013 under the reference number DK-DKMA-ADR 22320668 and DK-DKMA-EF07523. The patient ''s weight (60 kg) and height (169 cm) is reported. She received GARDASIL (dose 2, batch and lot # number J004851 exp date 31-AUG-2015) via intramuscular route of administration in not reported site of administration on 21-AUG-2013 and later on, 23-AUG-2013, she developed migraine type headaches. The patient has daily headache attacks, diffuse localised, strength 7-8/10, duration 0.5-1 hours at a time. She has 6-8 attacks daily. She has not been able to go to school since the reaction started, which is about almost 3 months. Now she home-schooled. It is unknown if she had other vaccines. No laboratory test or investigations performed. The patient received D1 GARDASIL (batch and lot number J002122, exp date 31-AUG-2015) via intramuscular route in not reported site of administration on 06-Jun-2013. The patient has no medical history. At the time of reporting, the patient had not recovered. The case has been assessed as serious by HA (seriousness: disability).
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