Age: 12.0
Sex: F
Vaccine: HEPA, HPV4, VARCEL, HEPA, HPV4, VARCEL
Symptoms: Muscle rigidity, Opisthotonus, Posturing, Syncope, Unresponsive to stimuli
Clinical narrative: Information has been received from a nurse concerning a 12 year old female with a history of "fainting incidence with medical procedures" (the patient's mother stated that the patient has had "3 previous fainting incidence with medical procedures throughout her life; the patient had fainted once when she was 3 years old when she skinned her knee and it was being cleaned by her mother), who on 10-SEP-2007 was vaccinated with the first dose of GARDASIL, (Lot# dose, and route not reported) and VARIVAX, (Lot #, dose and route not reported). On 16-APR-2008, the patient was vaccinated with her first dose of VAQTA, second dose of GARDASIL (Lot# dose, and route not reported) and VARIVAX, (Lot #, dose and route not reported), the patient fainted after the injections as per the physician report. The nurse reported that when she was called into the room by the physician the patient was sitting in the chair. Her back arched, eyes were opened and rolled back. She had posturing of the left hand and her body was rigid. The patient was lowered to the floor and came to. The incident lasted a total of one minute. The patient had not eaten breakfast, she was given something to eat, observed in the office, and was released home with her mother. The next day the patient suffered from a headache that she was kept home from school for. It was reported that the patient recovered on 18-APR-2008. No product quality complaint was involved. Additional information has been requested. This is in follow-up to report(s) previously submitted on 5/14/2008; 7/8/2008. Information has been received from a nurse concerning a 12 year old female with a history of "fainting incidence with medical procedures" (the patient's mother stated that the patient has had "3 previous fainting incidence with medical procedures throughout her life; the patient had fainted once when she was 3 years old when she skinned her knee and it was being cleaned by her mother), who on 10-SEP-2007 was vaccinated with the first dose of GARDASIL, (Lot# dose, and route not reported) and VARIVAX, (Lot #, dose and route not reported). On 16-APR-2008, the patient was vaccinated in right deltoid, IM, with her first dose of HAVRIX (lot # AHAVB171AA), expiration 20-DEC-2009, and received the second dose of GARDASIL (Lot#658554/0298U), expiration 12-APR-2010, IM to the left deltoid and VARIVAX (Lot #659427/1586U), expiration 29-SEP-2009, subcutaneously to the right arm at 12:25 pm. The patient fainted approximately one minute after the 3 vaccines had been administered the physician called for a nurse. The nurse reported that she had "tonic behavior." When she was called into the room by the physician the patient was sitting in the chair. Her back arched, eyes were opened and rolled back, and was unresponsive. She had posturing of the left hand and her body was rigid. The patient was lowered to the floor and "came to", she was oriented after being lowered to the floor. The incident lasted less than one minute. The patient had not eaten breakfast, she was given something to eat, observed in the office, and was released home with her mother, awake, alert and oriented. The patient's mother reported that her daughter suffered from a headache for 24 hours and she was kept home from school. It was reported that the patient recovered on 18-APR-2008. No product quality complaint was involved. This report is related to WAES#0806USA05075, the patients are twins.  Additional information has been requested