Age: 11.0
Sex: M
Vaccine: FLUX, HPV9
Symptoms: Colonoscopy, Constipation, Crohn's disease, Endoscopy, Gastric disorder
Clinical narrative: nuclear magnetic resonance imaging abnormal / MRI abnormal; inflammation / Was inflammed; blood test; colonoscopy; endoscopy; crohn's disease / Possible markers for Crohn's; colitis ulcerative / Ulcer colitis; laboratory test abnormal; abdominal pain / Cramping problems; weight gain poor / No weight gain; coeliac disease / Possible markers for [Crohn's and] celiac; growth failure / Fell low on the growth chart; irritable bowel syndrome; constipation / Constipated; bone scan abnormal; gastric disorder / Tummy issues; loss of personal independence in daily activities / Started missing school or be late, missing football and baseball practice; This report was identified from a line listing obtained on request by the Company from the FDA (agency number 764112) under the Freedom of Information Act on 09-JAN-2019.   Not sure who the flu shot was by, my son had the Vaccine for human papillomavirus (HPV) (hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9)) and within one month started having cramping problems and bathroom issues, took him in to doctor, and he was constipated and needed more fiber. Subsequently, they took him home, did that and added polyethylene glycol 3350 (MIRALAX) to helped it pass. This continued all year and kept him still having tummy issues, he increased with the frequency, started missing school or be late, missing football and baseball practice, needed to be close to a bathroom, and took him back in December 2016 for wellness check, where they let her know and she noticed he felt low on the growth chart now and had no weight gain over the past year, she gaved him a second HPV shot (hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9)) and one more flu shot, requested bone scan test and blood work. The scan came back 12-15 months delayed and a possible markers for Crohn's and celiac were present. They took him to the doctor in January, this led to series of test to confirm, not only did he have Celiac and Crohn's, he was also inflamed beyond any child should be without being in excruciating pain, magnetic resonance imaging (MRI) showed ulcer colitis and irritable bowel disease. Lab data  Patient has had colonoscopy, and Endoscopy and MRI, countless blood works and many follow ups, total of over 25 visits in the past 6 months.   Other Medications  None   Current Illnesses  None   History  None   Prior Vaccinations  The Agency determined all the aforementioned events to be non-serious.  Follow-up information has been downloaded from Regulatory Authority (US-SEQIRUS-201805000) on 06-FEB-2019.  A consumer was added as a new reporter. The previously reported influenza virus vaccine (unspecified), reported as "influenza virus vaccine polyvalent (+) influenza vaccine (INN FLU VACCINE SEASONAL)" It was confirmed that on an unspecified date in 2016, the patient started missing school or be late, missing football and baseball practice and the experienced tummy issues. On an unspecified date in December 2016, the patient presented a bone scan abnormal and then, on an unspecified date in January 2017, the patient presented the magnetic resonance imaging (MRI) abnormal.  The outcome of laboratory test abnormal, magnetic resonance imaging abnormal and bone scan abnormal was updated to unknown (previously reported as "not recovered"). The reporter did not provide the causality assessment between the suspect therapies and the aforementioned events.  The reporter determined the events ulcerative colitis ulcerative, laboratory test abnormal, abdominal pain, weight gain poor, loss of personal independence in daily activities, Crohn's disease, gastric disorder, bone scan abnormal, Celiac disease, growth failure, irritable bowel disease, constipation, nuclear magnetic resonance imaging abnormal and inflammation to be medically significant.  It has been determined that case # US-009507513-1902USA001996 is a duplicate of case # US-SEQIRUS-201805000. Therefore, case # US-009507513-1902USA001996 is being deleted from our files and the cases are consolidated into case # US-SEQIRUS-201805000.