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Administered by: Other Purchased by: Other
Life Threatening? No
Write-up: Information has been received from Sanofi Pasteur MSD (reference No. DK-1577272925-2016001636) as a part of a business agreement on 01-MAR-2016. Case received from non-health professional via company representative on 28-Jan-2016. A female patient of unknown age received GARDASIL, (batch/lot number and expiration date were not reported) on an unknown date. The reporter (also close relative to the patient), informs that the patient unintentionally received HPV vaccination at the age of 15 months. 7 years has passed and it is believed that the patient might have developed some adverse events from the vaccination. Since it is very rare that such a little human being gets this condition and as no immediate information can be found of other cases on the internet, the reporter requests information regarding possible known adverse events. The reporter is obviously concerned about the things they have confirmed with the patient and seeks for help. The patient experienced patient unintentionally received HPV vaccination at the age of 15 months on an unknown date, Medication error on an unknown date, cognitive difficulties on an unknown date, memory problems on an unknown date, learning difficulties on an unknown date, retention difficulties on an unknown date and excessive sleep on an unknown date. The patient''s outcome was reported as unknown. Follow-up information received on 22-Feb-2016. The following has been reported: during the first years nothing unusual was observed, but when she started pre-school, she had difficulty concentrating even at small tasks and were guided by adults. Retaken 0 class since she did not seem mature enough and have difficulty understanding collective messages or messages which should be performed several tasks in a row. In 0 class a program was compiled which showed cognitive difficulties, problems with executive functions and working memory. She has excessive sleep, difficulty concentrating, retention difficulties, learning difficulties and memory problems. This applies not only in schools but just as much in everyday life, where even small things can be difficult to remember. The family''s physician has not yet been contacted, but will soon be. The reporter wishes to know if there are known cases of other children being vaccinated by accident. The patient is under investigation and will later on contact the Health Authority. Upon medical review, the company judged relevant to assess the case as serous due to seriousness criterion disability. The patient''s outcome was reported as unknown.
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