Age: 61.0
Sex: F
Vaccine: HEP, HEP, HEPA
Symptoms: Colitis ulcerative, Colonoscopy, Condition aggravated, Multiple sclerosis
Clinical narrative: Ulcerative colitis; Multiple sclerosis; Condition aggravated; This case was reported by a physician via licensee and described the occurrence of ulcerative colitis in a 61-year-old female patient who received Hepatitis B vaccine (batch number 924TJ, expiry date 19th February 2021) for prophylaxis.   Co-suspect products included Hepatitis A vaccine (batch number 3L7ZG, expiry date 29th January 2021) for prophylaxis, Hepatitis B vaccine (batch number B39CM, expiry date 3rd February 2020) for prophylaxis and sodium fluoride (Prevident Gel) for product used for unknown indication.   The patient's past medical history included vitamin d deficiency, hyperlipidemia, colitis, alcohol use (Occasionally), anxiety disorder, arthritis (Joint pain), passive smoking and colonoscopy. Previously administered products included Pneumococcal (dose received on 26th October 2017 from lot number N014946 and expiry date 1st February 2019), Zoster live (dose received on 17th August 2017 from lot number N012615), Pneumovax (dose received on 2017) and Prevident (dose received on 31st August 2017). Concurrent medical conditions included depressive disorder, anemia, ulcerative colitis (Ulcerative colitis diagnosed in-2000), allergic to cats (Cat dander) and fruit allergy (Strawberry Thin skinned fruits). Concomitant products included tofacitinib citrate (Xeljanz) and benadryl (nos) (Benadryl).   On 11th December 2018, the patient received the 2nd dose of Hepatitis B vaccine (intramuscular) 1 ml. On 6th November 2018, the patient received the 1st dose of Hepatitis A vaccine (intramuscular) 1 ml and the 1st dose of Hepatitis B vaccine (intramuscular) 1 ml. On 6th March 2019, the patient started Prevident Gel at an unknown dose and frequency. On 4th April 2019, 114 days after receiving Hepatitis B vaccine and 149 days after receiving Hepatitis A vaccine and Hepatitis B vaccine, the patient experienced ulcerative colitis (serious criteria GSK medically significant), multiple sclerosis (serious criteria GSK medically significant) and condition aggravated. The patient was treated with citalopram, ferrous sulphate, glatiramer, loratadine + pseudoephedrine (Loratadine And Pseudoephedrine), simvastatin, bimatoprost (Lumigan) and vitamins nos (Multivitamin). On an unknown date, the outcome of the ulcerative colitis was recovering/resolving and the outcome of the multiple sclerosis was recovered/resolved and the outcome of the condition aggravated was unknown.   It was unknown if the reporter considered the ulcerative colitis, multiple sclerosis and condition aggravated to be related to Hepatitis B vaccine, Hepatitis A vaccine and Hepatitis B vaccine.     Linked case(s) involving the same patient:  US2022AMR164666, US2022AMR164886   Additional Information: GSK Receipt Date: 07-NOV-2022 Reporter's Comment: The reporter reported that the patient received Hepatitis A adult vaccine and after received Hepatitis A vaccine adult the patient experienced multiple sclerosis and ulcertative colitis. The reporter reported that the patient also received four doses of Covid 19,mRNA vaccine 1st dose received on 16th March 2021 from lot number EN6204 and expiry date 12th June 2021 by intramuscular route at right deltoid 2nd dose received on 06th April 2021 from lot number EW0150 and expiry date 31st July 2021 by intramuscular route at left deltoid, 3rd dose received on 27th August 2021 from lot number EW0191and expiry date 30th September 2021 by intramuscular route at left deltoid, 4th dose received on 08th March 2022 from lot number FK9729 and expiry date 01st April 2022 by intramuscular route at right deltoid Influenza injectable quadrivalent vaccine 1st dose received on 31st October 2019 from lot number UT6686JA , 2nd dose received on 27th September 2020 from lot number UT7011JA, 3rd dose received on 20th October 2021 from lot number UT7317LA, the patient received Hepatitis A adult vaccine on 24th May 2019. The reporter stated that the patient received 3 doses of Hepatitis B adult vaccine on 06th November 2016, 11th December 2018 and 24th May 2019. The patient received zoster recombinant on 18th August 2022. The reporter stated that the patient with ulcerative colitis was diagnosed in 2000 and previously she was received Entyvio which was did not work well for patient and currently she was on Xeljanz which was working well for her. The patient had not required surgery for her disease and the patient also had multiple sclerosis. Reporter reported that patient had normal appetite, no change in bowel habit, no nausea, no vomiting, no diarrhea, no painful bowel movements, no constipation, no rectal bleeding, no blood in stool, no abdominal pain, no heartburn and no peptic ulcer.  The patient had reports good general health lately, no significant weight gain, no significant weight loss, no fever, no fatigue, and no headaches. She reports no heart trouble, no chest pain, no palpitations, no shortness of breath when walking, no shortness of breath when lying down, and no edema. patient does not had chronic cough, spitting up blood, shortness of breath, asthma or wheezing, and sleep apnea.  Patient not had joint pain, joint stiffness, muscle weakness, muscle pain/cramps, back pain cold hands or feet, and difficulty walking. She reports no rashes, no itching, no change in color of skin, no hair changes, no change in nails, no varicose veins, no breast pain, no breast lump, and no nipple discharge. She reports no frequent headaches, no lightheadedness, no dizziness, no convulsions or seizures, no numbness, no tingling sensation, no tremors, no paralysis, and no history of stroke. She reports no cuts slow to heal, no bleeding, no bruising, no anemia, no phlebitis, no recent transfusion, and no enlarged glands. The patient done with colonoscopy on 01st June 2020. The patient done with colonoscopy on 20th July 2021 without any active disease. On 4th April 2019, 29 days after receiving Prevident Gel, the patient experienced ulcerative colitis and multiple sclerosis. It was unknown if the reporter considered the ulcerative colitis and multiple sclerosis to be related to Prevident Gel The reporter did consent to follow up. Additional supportive information: This case had been linked with US2022AMR164666 and US2022AMR164886 by same reporter for same patients.; Sender's Comments:  US-GSK-US2022AMR164666:Same reporter US-GSK-US2022AMR164886:split case (vaccine case)