Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TDAP, VARCEL, HPV4, MNQ, TDAP, VARCEL, HPV4, HPV4, MNQ, TDAP, VARCEL
Symptoms: Asthenia, Dizziness, Inappropriate schedule of drug administration, Syncope
Clinical narrative: Information has been received from a pharmacist and a registered nurse concerning a 12 year old female patient who on 28-APR-2008 was vaccinated with the first dose of GARDASIL (Lot # 659962/1740U), intramuscularly. On 25-JUL-2008, was vaccinated with the second dose of GARDASIL vaccine (Lot # 656055/0070X) and on 04-NOV-2008, was vaccinated with the third dose of GARDASIL vaccine (Lot# 660555/0279X). Concomitant therapy included diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid, VARIVAX (MSD) and MENACTRA.  The pharmacist reported that the patient had been experiencing dizzy spells since receiving her first dose of GARDASIL.  The dizzy spells began on 15-05-2008 and she had had 25-30 dizzy spells since that time.  The pharmacist reported that GARDASIL series had been completed, the dates of those immunizations was unknown by the pharmacist.  At the time of the report, the patient had not recovered.  The patient sought medical attention through an office visit.  No further information is available.  This is in follow-up to report (s) previously submitted on 2/13/2009. On 28-APR-2008, the patient also received the following vaccines dipetheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid (Lot # AC52H020AA), VARIVAX vaccince (MSD) (Lot # 15840), and MENACTRA (Lot # U2848AA). Other vaccine given on 04-NOV-2008: influenza virus vaccine (unspecified) (Lot # U2848AA). On 21-JAN-2009, the pharmacist reported that the patient had been experiencing dizzy spells since receiving her first dose of GARDASIL vaccine. The dizzy spells began on 15-MAY-2008 and she had had 25-30 dizzy spells since that time. The pharmacist reported that GARDASIL vaccination series had been completed, the dates of those immunizatins were unknown by the pharmacist. The pharmacist reported that the patient had not recovered from the event and that she sought medical attention through an office visit. On 23-JAN-2009, the registered nurse reported that the patient had fainted several times and became weak after completing the GARDASIL vaccination series. Follow-up information received fromthe registered nurse via phone call indicated that she was 12 year old patient , with no personal of family history of seizures and no known drug reaction/allergies. The nurse stated that in January 2009, the patient's mother called the clinic requesting the HPV vaccine' lot numbers and it was during that call that the clinic learned of the adverse experiences. The event was described as "dizzy spells with patient seeing spots then going black". The patient did not actually faint. There has been many spells since then. The mother reproted that the onset of the first spell was in mid-May 2008. The mother further reported to clinic that the doctor was running test and that her daugther had been referred to a neurologist (no names provided to the clinic). This is a consolidation of two reports concerning the same patient. No further information is available.