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Life Threatening? No
Write-up: Information has been received from Sanofi Pasteur MSD (SPM) (MFR control number IE-1577272925-2016009610) on 26-SEP-2016. This case was received from the agency on 21-SEP-2016 under the reference number IR-HPRA-2016-028844. Initial report was received by the agency on 07-SEP-2016, from a member of the public (patient''s mother) which concerns a 12 year old female patient who experienced injection site swelling, headache, pyrexia, nausea, lymphadenopathy, muscular disorder, skin striae, rash, hypermobility syndrome, syncope, injection site pain, injection site bruising and fibromyalgia following vaccination with GARDASIL. Concomitant medications: none. Medical history/concurrent conditions: none. The patient was vaccinated with 3 doses of GARDASIL (dose 1 on 13-SEP-2010 (batch/lot no. NM11420), dose 2 on 17-NOV-2010 (batch no. NM46680) and dose 3 on 14-MAR-2011 (batch no. NM3113). The patient collapsed after dose 1 and was sent home from school. She also became quite ill after each subsequent dose. She experienced pain, swelling and bruising at injection site, headaches, fever, nausea, swollen glands, muscle weakness, tingling/abnormal sensations in arms and legs, vomiting, joint pain, aching muscles, chronic fatigue, chills, bleeding and bruising easily, issues with menstrual cycle, stretch marks, skin rash and hypermobility. The patient has been seen by a number of consultants for different symptoms, has been hospitalized on a number of occasions and is currently waiting to be seen by more specialists. At present she has been diagnosed with fibromyalgia and has told by a rheumatologist and a number of physiotherapists that she is hypermobile. The reporter indicated that no diagnosis has been made to cover all of her symptoms. At the time of reporting the patient''s symptoms were persisting.
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