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Administered by: Unknown Purchased by: Unknown
Life Threatening? No
Write-up: Information has been received from a pediatrician concerning a 16 year old female with a history of dental extraction (date not reported), ataxia and nonspecific dizziness (onset and latency not reported) who at the end of November 2007, was vaccinated with a dose of RECOMBIVAX HB (manufacturer unknown) (lot # not reported) (route and site not reported). Suspect vaccination administered on that same day included a dose of IPOL (unspecified) (IV MERIEUX) (lot# not reported) (site and route not reported). After the vaccinations with RECOMBIVAX HB (manufacturer unknown) and IPOL (Vero) in November 2007, the patient experienced ataxia and dizziness that reappeared and worsened. The patient was hospitalized on 03-DEC-2007 due to dizziness, nausea and relapsing headache in the morning for the last 2 to 3 weeks. At the weekend before hospitalization the patient complained of severe headache, delusional perception, photophobia, phonophobia and the feeling of dyspnea. She also complained of psychological stress at work. EEG, ECG and songraphies were performed which were without pathological findings. Routine lab parameters only showed increased inflammatory parameters for respiratory infection (on 05-DEC-2007: CRP 5.0 mg/dl, normal range < 1 mg/dl). Therefore the patient was treated with docycycline (onset and dose were not reported). Under this therapy the laboratory findings (values not reported) and the condition of the patient improved. She was referred to the child and adolescent psychologist due to her stress situation. It was also noted that the patient on 24-OCT-2007 was vaccinated IM with her first dose of Gardasil (MSD) (batch# NF56940, lot# 0278U) (site not reported) experienced ataxia and nonspecific dizziness and recovered on 05-NOV-2007. The patient had an MRI (date and site not reported) which was without pathological findings. On 07-DEC-2007 the patient was discharged from the hospital in good general condition. Other business partner numbers include: E200801915 and linked with case E200800806 (same patient). Additional information has been requested.
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