Age: 40.0
Sex: M
Vaccine: HPV4
Symptoms: Mean cell volume decreased, Neoplasm malignant, Off label use, Polyp
Clinical narrative: Information has been received from a male in his forties who was vaccinated with 2 doses of GARDASIL (dose, therapy route unspecified). No AE reported. Follow up information has been received from the 43 year old male consumer indicated that he was vaccinated with two doses of GARDASIL before it was approved for men. He received the first dose of GARDASIL on 05-MAR-2008 and the second dose of GARDASIL on 23-APR-2008. He did not receive a third dose of GARDASIL. There were no lot number was provided. It was unknown if the patient sought medical attention. At the time of report the patient's status was unknown. Additional information has been received from the 43 year old male patient who was vaccinated with his first and second doses of GARDASIL in March 2008 and April 2008. The patient stated then he was diagnosed with colon cancer in October 2008. He underwent surgery and chemotherapy and he was in remission. No further information was available. Upon internal review, colon cancer was considered to be an other important medical event. Additional information has been received from a medical assistant concerning the 40 year old male patient (previously reported as 43 years old) was referred to a physician of gastroenterology and internal medicine. The patient was admitted to hospital on 30-OCT-2008. The patient had a laparoscopic anterior resection (hospitalization dates were not reported). It was reported that on 18-DEC-2008 the patient was admitted to hospital for a total abdominal colectomy (hospitalization dates were not reported). Additional information has been received from the medical assistant from the administering physician's office who stated that there was no documentation in the patient's chart that he received any GARDASIL vaccinations at the physician's office. Follow up information has been received from the physician via medical records indicated that the patient was a 41 year old male with a long history of irritable bowel, some rectal bleeding for about six months and a family history of colon cancer in his father who was diagnosed at age 51 and also in his grandfather and a history of colonoscopy approximately 2006 and was normal apart from 3 mm polyp in the rectum which was removed with hot biopsy forceps and was a benign adenoma. On 15-OCT-2008 patient was colonoscoped by the physician and found a sigmoid colon cancer at about 30 cm biopsy results showed diffuse invasive adenocarcinoma. The patient's hemoglobin was 8.7, liver function tests (LFT) were normal, MCV 75, CEA 0.6 and a CT of abdomen and pelvis were done on 17-OCT-2008: results not reported. The patient also had a sessile polyp at about 15 cm. The patient's sigmoid cancer was at 30 cm from the anus. It was circumferential. The patient required a colonoscopy after his sigmoid resection. On an unspecified date the patient underwent a sigmoid resection for colon cancer. A CT scan was done, on an unspecified date and showed a mass in the ascending colon. On 17-DEC-2008 patient had a colonoscopy done which showed that the patient had internal hemorrhoids. The rectum was normal. The anastomosis was a little ulcerated and edematous. The transverse colon, hepatic fixture and right colon were normal. Above the cecum was a 3 to 4 cm exophytic, nodular, friable mass lesion that had the endoscopic appearance of a carcinoma, biopsy results were pending. Additional information is not expected.