Age: 78.0
Sex: M
Vaccine: VARZOS
Symptoms: Flatulence, Gastrointestinal disorder, Immediate post-injection reaction, Weight decreased
Clinical narrative: This case was reported by a physician and described the occurrence of ulcerative colitis in a 78-year-old male patient who received SHINGRIX for prophylaxis. The patient had a Family History of ulcerative colitis (Sister of the patient had ulcerative colitis approximately at age 80) and rheumatoid arthritis (Same sister of patient also had Rheumatoid arthritis). Previously administered products included SHINGRIX (1st dose received on 7th February 2018 in left deltoid). Concurrent medical conditions included hypertension. On 11th April 2018, the patient received the 2nd dose of SHINGRIX. On 11th April 2018, 91 days after receiving SHINGRIX, the patient experienced ulcerative colitis (serious criteria disability, GSK medically significant and life threatening), diverticulitis (serious criteria GSK medically significant and life threatening), diarrhea (serious criteria clinically significant/intervention required) and gas. On an unknown date, the patient experienced weight loss and gastrointestinal symptom nos. The patient was treated with XELJANZ. On an unknown date, the outcome of the ulcerative colitis and diarrhea were recovering/resolving and the outcome of the diverticulitis, weight loss and gastrointestinal symptom nos were unknown and the outcome of the gas was recovered/resolved. The reporter considered the ulcerative colitis and diarrhea to be possibly related to SHINGRIX. It was unknown if the reporter considered the diverticulitis, weight loss, gas and gastrointestinal symptom nos to be related to SHINGRIX. Additional details were provided as follows: Patient's medical history include hichol of longstanding under control with medical treatment. Enlarged prostate on finasteride. No prior history of constipation or diarrhea. The sister of the patient with ulcerative colitis at approx. No other known inflammatory bowel disease (IBD) in family. Same sister of the patient also has rheumatoid arthritis. The patient reports that he had his first dose of SHINGRIX with no significant post vaccination events. The patient received his shots both times in the left deltoid as he was right hand dominant. Immediately after receiving 2nd dose of the SHINGRIX vaccine, about 1 year ago, the patient developed systemic issues including new, persistent diarrhea. The patient reports a high tolerance for pain and did not recall any significant limb pain with either dose nor any other symptoms post dose 2 except for shortly after receiving the vaccine the same day the patient became very gassy lasting 1 to 2 days followed by diarrhea which he attributed to food that disagreed. When it persisted, the patient saw his primary care and dietary changes were made with no improvement. When there was no resolution of the symptoms and a 30 lbs weight loss occurred, a Gastroenterologist was consulted and after a colonoscopy work up where no polyps were found, the patient was diagnosed with diverticulitis and Ulcerative Colitis. The patient elected to begin treatment with XELIJANZ and has been well controlled over the last 6 months on it, and had regained most but not all of the weight he lost (now at 150 lbs). The patient continues on this very costly, but effective drug. The patient reported having been on continuous positive air pressure (CPAP) before his weight loss and now (at the time of reporting) no longer requires it. The patient also reported he no longer required his hypertension (HTN) medication when he lost all the weight, but back now at 150 lbs the patient did need it. Patient did not necessarily think that his ulcerative colitis (UC) had anything to do in a causal manner with SHINGRIX, but did report a temporal association with the gut symptoms after the 2nd dose of SHINGRIX. The patient was willing to receive phone calls and provide other medical history as needed from the safety team. The events did not cause the patient to be admitted to the hospital overnight or prolong an existing hospitalization. The reporting health care professional consider the event to be life threatening. The reporting health care professional consider the event to result in persistent or significant disability or incapacity. The patient did not die. The events require surgical or medical intervention to prevent one of the outcomes described in preceding questions. The events did not result in a congenital anomaly or birth defect. Lab Comments: In 2018, the colonoscopy was performed in which no polyps were found, the patient was diagnosed with diverticulitis and Ulcerative Colitis.