Age: 12.0
Sex: F
Vaccine: HPV4, VARCEL, HPV4, VARCEL
Symptoms: Colectomy, Colitis ulcerative, Cough, Diarrhoea, Rectal haemorrhage
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 12 year old female with environmental allergies as well as an allergy to penicillin and a history of tonsillectomy was vaccinated intramuscularly with the first dose of GARDASIL (lot# 655503/0012U) on 23-AUG-2007. She was vaccinated with the second dose of VARIVAX (Oka/Merck) (lot# 657752/0780U) on the same date. After receiving vaccine, the patient started having bouts of rectal bleeding and diarrhea. In additional to this she had a very loud barking "chronic" cough. She was finally diagnosed with ulcerative colitis. She had to have a total colectomy resulting with an ostomy and several blood transfusions. On 28-APR-2009 extensive medical record was received for multiple hospital admissions and emergency room visits from MAY 2008-APRIL 2009 with the following discharge diagnoses. Date of service: 03-OCT-2008 to 05-OCT-2008 for inflammatory bowel disease and anemia status post PRBC transfusions. Date of service: 08-OCT-2008 to 31-OCT-2008 for ulcerative colitis, pancreatitis status post laparotomy colectomy with ileostomy, explorative laparotomy with adhesiolysis and wash out. Date of service: 5-JAN-2009 to 08-JAN-2009 ulcerative colitis status post colectomy, acute pancreatitis, pancreas divisum and urinary tract infection. Date of service: 16-FEB-2009 to 22-FEB-2009 for laparotomy cholecystectomy, laparotomy assisted J-pouch ileorectal anastomosis, anorectal pull through, loop ileostomy. Date of service: 03-APR-2009 to 06-APR-2009 for ulcerative colitis, pancreatitis, bowel Obstruction. Multiple emergency room visits with diagnose: on 25-APR-2008 the patient was diagnosed with cough and hematochezia. On 04-MAY-2008 the patient was diagnosed with gastrointestinal bleed and abdominal cramping. On 22-MAY-2008 the patient was diagnosed with Crohn's exacerbation and on 08-JUN-2008 rectal bleeding. On 26-JUL-2008, 27-JUL-2008, and 08-SEP-2008 the patient was diagnosed with Crohn's Flare. On 08-OCT-2008 the patient was diagnosed with Inflammatory Bowel Disease and drug induced pancreatitis. On 17-NOV-2008 the patient was diagnosed with gastroenteritis as well as multiple episodes of abdominal pain. The patient consulted otolaryngology on 08-SEP-2008 for 9 month history of chronic cough. The patient was seen in pulmonary clinic on 26-MAR-2009 for follow up of chronic cough 2 to ulcerative colitis. The patient initially presented on 25-APR-2008 with complained of 4 weeks history of chronic cough, sore throat and 2 week history of rectal bleeding. Physician exam was within normal limit. The patient returned on 02-MAY-2008 with follow up rectal bleeding and abdominal pain-frank blood and diarrhea. Frequent hospitalizations and emergency room visits as above continue to present with multiple surgeries and procedures. Laboratory tests were performed: blood hemoglobin test result was 9.7; KUB X-ray was within normal limit; white blood cell count was 19.8; erythrocyte sedimentation rate and serum C-reactive protein elevated; blood platelet count was 583; computed axial tomography indicated positive for bowel obstruction; Ultrasound indicated Gall Bladder (+) for thickening; pancreatic enzymes increased; serum lactate dehydrogenase test result was 540 (high); serum lipase test result was 1279-8249 (high). The patient required an emergency room visit. The listing indicated that one or more of the events required hospitalization, was considered to be disabling and immediately life-threatening. The original reporting source was not provided. The VAERS ID# is 344440. No further information is available. A standard lot check investigation was performed. All in-process quality checks for the lot number 657752/0780U were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the Center and was released.   5/12/10 Follow up: Mariah required 5 total surgeries to correct this. Her entire colon had to be removed. She will have to live with the side effects of that for the rest of her life.