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FDA Freedom of Information Distribution: VAERS Line List Report

In general, planning a special event or mass gathering should begin well in advance of the event. One of the first steps in planning an event is to bring together those who are hosting the event with those who are responsible for the public safety within the community. A multidisciplinary planning team or committee should be composed of the promoter or sponsor and any agency that holds a functional stake in the event (e.g., emergency management, law enforcement, fire and rescue, public works/utilities, public health, etc.). With all of these agencies present, there is an obvious risk. | FDA Freedom of Information Distribution Report run on 11 MAY 2007 03 14 VAERS Line List Report Vax Name HPV GARDASIL All comb. w AND Page 1 Vaers Id 259545-1 S Related reports 259545-2 Age Gender 14.0 Vaccine Date Onset Date F 11-Jul-2006 11-Jul-2006 Days 0 Received Date 14-Jul-2006 VAX Detail Type HPV4 Manufacturer MERCK CO. INC. Lot 0637F Status Date 14-Jul-2006 Prev Doses 0 Site State DC Right arm Mfr Report Id Route Unknown Last Edit Date 13-Nov-2006 Other Vaccine Seriousness ER VISIT HOSPITALIZED SERIOUS MedDRA PT Dehydration Fall Headache Hyperventilation Injection site pain Muscle spasms Speech disorder Syncope Vision blurred Vomiting Symptom Text Immediately after injection complained of severe pain at site. Fell off table and fainted for approximately 10 - 15 seconds. Hyperventilated and cried progressing Chvostek s sign in hands and feet. Rebreathing into a bag progressing to clearing of symptoms. Complained of headache blurry vision Vision test was normal. Vomiting x 1 in parking lot and speech was momentarily inarticulate. Sent to ER. At ER neuro exam was normal except for word recall coffee instead of coughing Sired instead of tired. Continued complaint of headache. Vomited x 2. All symptoms spontaneously cleared approximately 6 hours after incident. Overnight hospitalization for observation. Neurological evaluation before discharge was normal. Diagnosis also included dehydration. No fluids were taken from 7 10 2006 PM until IV in ER. Anion gap noted on chemistries and concentration of urine obtained after several hours of hydration. Discharge diagnosis Dehydration Vasovagal syncope secondary to shot vs pain at injection site. 7 17 06 Medical records received from reporter provider which included vax record office note of 7 11 neuro consult of 7 15 by MD who also saw her in the hospital on 7 11-12. Neuro report indicates the CT scan of head was WNL that dx is syncope probably precipitated by pain of vax injection along w dehydration no fluid intake .