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Life Threatening? No
Write-up: Initial information has been received from a physician via the Agency concerning a 14 year old female patient who on 29-SEP-2012 received the second vaccination with a dose of GARDASIL intramuscular injection (Lot no. 9QN04R, dose not reported). Information including underlying/concomitant diseases and medical history was not obtained. On the pre-vaccination interview form, special notes (including underlying disease, allergy, vaccination and disease during recent one month, regular medications, adverse drug reaction history and growth status) were unknown. The body weight at birth was 3296g. Other concomitant medications were not reported. On 26-JUL-2012, the patient received the first vaccination of GARDASIL (Lot no. 9QN04R) at another hospital. On 29-SEP-2012, the patient received the second vaccination of GARDASIL (Lot no. 9QN04R) at another hospital. She had general malaise. On 26-JAN-2013, the patient received the third vaccination of GARDASIL (Lot no. 9QN06R) at another hospital. Forty minutes after, the patient presented with anxiety and dyspnea. On an unspecified date, the patient developed higher brain dysfunction. In June 2014, the patient made the first visit to the reporting hospital. Perceptual disturbance, sleep disorder, memory impairment, irregular menstruation and psychogenic non-epileptic seizure were noted. As of the time of this report, the patient had not recovered from high brain dysfunction. Reporter''s comment: Not reported. The reporting physician considered higher brain dysfunction as serious due to possible disability (also reported medically significant). The reporting physician felt that higher brain dysfunction was related to GARDASIL with no other causative factor. Additional information has been requested.
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