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Administered by: Other Purchased by: Other
Life Threatening? No
Write-up: This case was reported by a healthcare professional and described the occurrence of multiple sclerosis in a 15-year-old female subject who was vaccinated with ENGERIX B (GlaxoSmithKline) and GARDASIL (non-gsk). Historic vaccination included hepatitis B;GlaxoSmithKline;unknown given on an unspecified date. Concurrent vaccination included hpv vaccine (non-gsk) ;non-GSK manufacturer;unknown;unknown given on 14 December 2011. On 7 March 2012, the subject received 3rd dose of ENGERIX B (administration site and route unknown, batch number not provided) and 2nd dose of GARDASIL (unknown). The 1st and 2nd doses of ENGERIX B were given 5 years earlier. The vaccination schedule was therefore lengthened. By the end of March 2012, less than one month after vaccination with GARDASIL and ENGERIX B, the subject experienced numbness in the lower limbs extended to hip. Hospital diagnoses were inconclusive. The healthcare professional considered the events were clinically significant (or requiring intervention). On October 2012, a magnetic resonance imaging brain was performed. Multiple sclerosis was suspected. Later on, this diagnosis was confirmed. At the time of reporting, multiple sclerosis was unresolved. The healthcare professional considered multiple sclerosis was possibly related to vaccination with ENGERIX B and GARDASIL. Follow-up information received on 6 March 2013: The DOB and patient''s initials were provided. The lot number of ENGERIX B was provided. The healthcare professional no more considered the case as clinically significant (or requiring intervention) but aw disabling. In March 2012, in addition to the above mentioned events, the subject experienced leg paresthesia. Multiple sclerosis was the hypothesis diagnosis. Follow-up information received on 16 April 2013: In October 2012, multiple sclerosis was diagnosed. Follow-up information received on 22 April 2013: This case was also reported by a physician via a regulatory authority (PT-INFARMED-S201304-63). In March 2012, 3 weeks after vaccination with GARDASIL and ENGERIX B, the subject experienced leg paresthesia and headache. The regulatory authority considered the events were clinically significant (or requiring intervention). Despite treatment, the events were unresolved. Follow-up information received on 21 June 2013: The magnetic resonance imaging brain performed on 23 October 2012 detected multiple dispersed lesions in the white substance of the cerebral tissue. Multiple sclerosis could be present before or after vaccination. The regulatory authority considered multiple sclerosis and leg paresthesia were unlikely related to vaccination with ENGERIX B and GARDASIL. Headache was possibly related. Follow-up information received on 8 July 2013: The regulatory authority considered multiple sclerosis and leg paresthesia were possibly related to vaccination with ENGERIX B and GARDASIL.
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