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Administered by: Other Purchased by: Other
Life Threatening? No
Write-up: Information has been received from a pharmacist on 28-MAY-2010 concerning a 23 year old female. The patient had received a first dose of GARDASIL (lot # not reported) in her arm on 20-APR-2010. Immediately after vaccination the patient presented with injection site pain which lasted for a week (recovered on 26-MAY-2010). One month after vaccination (on approximately 20-MAY-2010) the pain returned radiating from shoulder to elbow and preventing the patient from making certain movements. The patient was treated with anti-inflammatory cream. At the time of reporting the patient had not recovered. Follow-up information received on 02-SEP-2010: The patient had received the first dose of GARDASIL (lot # 0777X, batch # NJ35160) via intramuscular route in the left arm on 20-APR-2010. She received the second dose of GARDASIL (lot # NJ49350, batch # NL35360) via intramuscular route in the left arm on 24-JUN-2010. One month after each vaccination, the patient experienced incapacity to move the arm during 7 days and formications in the vaccinated arm which lasted 4 days. The most severe pain had regressed at the injection site but the patient had always a persistent pain at the injection site when touching the arm. According to the reporter, the events were moderate and not serious and the patient was on her way of recovering at the time of reporting. A corrective version was created on 25-NOV-2010: upon internal review, "paralysis of arm" was considered as an important medical event and the case was upgraded to serious. Other business partner numbers included E2010-03349.
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