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Administered by: Private Purchased by: Private
Life Threatening? No
Write-up: Information has been received from a consumer concerning her 16 year old daughter, with a sulfonamide allergy and drug hypersensitivity to codeine, who on 18-APR-2007 was vaccinated IM in the left arm, with the first dose, 0.5 ml, of GARDASIL vaccine (Lot # 655320/0088U). There was no concomitant medication. The patient''s mother reported that on 18-APR-2007, immediately after receiving the vaccination, her daughter got pale, said she was going to throw up, and felt faint for about 15 minutes. The mother then added that while going out to the car, her daughter had 3 recurrences of feeling like she was going to faint, and had to sit with an ice pack on her neck for 10 minutes with each occurrence. On the way home in the car, her daughter complained that her hands and feet felt tingly and her vision became blurred for about 10 minutes. Once at home, the mother explained that her daughter experienced severe stomach cramps, and then one hour later had diarrhea "which lasted through the night and into the early afternoon of the next day." On 19-APR-2007 ("the next day"), she became extremely lethargic, fell asleep at 2pm and slept until the next day. On approximately 20-APR-2007 ("the next day"), the mother said her daughter "felt better," however, the arm where the injection was administered was extremely sore, and no pressure could be tolerated on that arm; she confirmed that her daughter had recovered from all of the symptoms, with the exception of her sore arm, which was "still tender but gradually improving." Additional information has been requested. This is in follow-up to report (s) previously submitted on 5/14/2007. Follow up information received from ahealthcare professional, indicated there was no illness at the time of vaccination, and confirmed the events of diarrhea and tingling in the arms and legs occurrred and lasted for 24 hours. however, the date of vaccine adminstration was reported by the healthcare professional as 05-MAR-2007, with a date of recovery on 06-MAR-2007. No further information is expected.
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