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Administered by: Other Purchased by: Other
Life Threatening? No
Write-up: Information was received from Sanofi Pasteur MSD (IE-1577272925-2016000608) on 01-FEB-2016. This case was received from the health authority on 27-01-2016 under reference number IE-HPRA-2016-025696. Initial report was received by the RA on 12/Jan/2016 from a member of the public (patient''s mother) concerning a 13 year old female patient who experienced myalgia, arthralgia, asthenia, fatigue, headache, dysstasia, disturbance in attention, photophobia, phonophobia, dizziness and insomnia following vaccination with GARDASIL. Concomitant medications included BOOSTRIX. The patient also received a meningitis vaccine in 2012/2013. The patient''s medical history/concurrent conditions were not reported. The patient was vaccinated with GARDASIL (lot numbers H008259, expiration date not reported, on 25/Sep/2012 and H013137, expiration date 12-DEC-2010, on 8/Apr/2013) at an unspecified dose initially. The patient received all three doses of GARDASIL. On 10/Sep/2013, the patient developed muscle and joint pain, weakness all over her body, fatigue, headaches, an inability to walk or stand for very long, poor concentration, intolerance to light and noise, dizziness and insomnia. Corrective treatment included physiotherapy, DIFENE, SURMONTIL, NEURONTIN, acupuncture, massage, reiki and various other ''energy healing'' therapies. The patient outcome was reported as not recovered/not reported.
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