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Administered by: Unknown Purchased by: Unknown
Life Threatening? No
Write-up: Case received from the Health Authorities on 01-SEP-2011 under the reference number C201108-1742 via the local site Sanofi Pasteur MSD. Case medically confirmed. Initial reporter was a physician, specialist in medicine and physics rehabilitation. A 13-year-old female patient presented with right facial peripheral paralysis on 07-JUN-2011 after she had received a first dose of GARDASIL (lot # 1334X, batch number NL30760-1) via intramuscular route on 15-APR-2011. At the time of vaccination the patient was not given any concomitant medication. She had physical disability as a result of the facial paralysis. According to the specialist, the patient was unable to completely close her right eye and she had difficulty in chewing and smiling. Specific treatment was started, with acyclovir 800 mg 4 tablets a day per os for 7 days and physiotherapy sessions. Physiotherapy was still ongoing at the time of reporting. Her condition was improving with this specific treatment. The course of HPV vaccination was interrupted due to the reported reaction and at the time of reporting the patient had not received the second dose of GARDASIL. To be noted that there were no known reactions to other drugs prior to vaccination. At the time of reporting the outcome was recovering. Further confirmation concerning the batch number was expected as the reported batch was not distributed. Right peripheral facial paralysis was considered to be an other important medical event by the Health Authorities. Other business partner numbers include E201105370. No further information is available.
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