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Administered by: Unknown Purchased by: Unknown
Life Threatening? No
Write-up: Information has been received from a physician concerning a 24 year old female patient who on 26-AUG-2008 was vaccinated with the first dose of GARDASIL (Lot#660557/0072X), 0.5ml. On 27-OCT-2008 the patient was vaccinated with the second dose of GARDASIL (Lot#660557/0072X), 0.5ml, and on 21-MAY-2009 the patient was vaccinated with the third dose of GARDASIL (Lot#661953/1130X), 0.5ml. MENACTRA (Lot#U2877AA) was administered during the same visit. There was no other concomitant medication. On 21-MAY-2009, 5 minutes after receiving her third dose of GARDASIL, the patient fainted and fell on the floor. She was now experiencing severe headache and she also had a "busted lip" and her upper tooth was loose. The patient was not recovered now and she had sought medical. Additional information was received from a medical assistant that the patient was admitted to a hospital on 21-May-2009. The admitting diagnoses were reported as syncope, head trauma, severe headache, reaction to vaccine, contusion to mouth, and laceration to lower lip. It was also noted that the patient''s two front teeth were loose. When the patient was discharged and the patient''s recovery status were both unknown. The patient was not scheduled for a follow-up visit with the physician. Additional information has been requested. 7/8/09 Received PCP & vaccine records. Patient was seated during injection of vaccines and after 5 min, fell onto the floor sustaining facial injuries. Observed in office 40 min. BP prior ro vaccines 110/80; after fall 8/40; then returned to 110/70. Stable & d/c to home w/parents. Phone contact w/parent that evening revealed patient c/o HA, toothache & dizziness. Admitted to hospital for 23 hr observation. Remained stable & d/c to home. Seen again in PCP office for cellulitis/abscess left thigh/hip. No further problems. 6/9/09 Hospital records received DOS 5/21/09. Admitting diagnosis: syncope, head trauma, headache, reaction to immunizations.
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