Age: 76.0
Sex: M
Vaccine: COVID19, FLUX
Symptoms: Computerised tomogram thorax, Vaccination failure
Clinical narrative: COVID-19/sinus issues; Vaccination failure; COVID Pneumonia; Flare up of Ulcerative Colitis; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19/sinus issues), COVID-19 PNEUMONIA (COVID Pneumonia) and COLITIS ULCERATIVE (Flare up of Ulcerative Colitis) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027A21A and 031L20) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.    Co-suspect products included non-company products TOFACITINIB CITRATE (XELJANZ) for Ulcerative colitis and INFLUENZA VACCINE (FLU VACCINE VII) for an unknown indication.    The patient's past medical history included Renal cell carcinoma, Ulcerative colitis, Melanoma in 2020, Basal cell carcinoma and Renal surgery. Concurrent medical conditions included Hypothyroidism (Hypothyroidism was diagnosed about 15 years ago.), Hypertension, Skin disorder NOS (Patient had lot of skin issues and sees a dermatologist every 3 months for a body check.) and Enlarged prostate (Patient was diagnosed with this condition 4-5 years ago). Concomitant products included TAMSULOSIN and FINASTERIDE for Enlarged prostate, LEVOTHYROXINE for Hypothyroidism, DILTIAZEM HYDROCHLORIDE (CARDIZEM [DILTIAZEM HYDROCHLORIDE]), CLONIDINE and PREDNISONE for an unknown indication.   In 2019, the patient started TOFACITINIB CITRATE (XELJANZ) (unknown route) 5 milligram twice a day. On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of INFLUENZA VACCINE (FLU VACCINE VII) (unknown route) 1 dosage form. In September 2021, the patient experienced COVID-19 PNEUMONIA (COVID Pneumonia) (seriousness criterion medically significant) and COLITIS ULCERATIVE (Flare up of Ulcerative Colitis) (seriousness criterion medically significant). On an unknown date, the patient experienced COVID-19 (COVID-19/sinus issues) (seriousness criterion hospitalization) and VACCINATION FAILURE (Vaccination failure). The patient was hospitalized on sometime in July 2021 due to COVID-19. The patient was treated with VANCOMYCIN (oral) at an unspecified dose and frequency. At the time of the report, COVID-19 (COVID-19/sinus issues), COVID-19 PNEUMONIA (COVID Pneumonia), COLITIS ULCERATIVE (Flare up of Ulcerative Colitis) and VACCINATION FAILURE (Vaccination failure) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In July 2021, Blood potassium: Low. In July 2021, Blood sodium: 111. In September 2021, Computerised tomogram thorax: showed COVID pneumonia or waking Pneumonia and inflamed diverticulitis.         Patient received booster dose of the Moderna vaccine on 20-Oct-2021 and batch lot number was reported as 039B1A. It was reported that patient had three different types of Basal Cell Carcinoma and most recent was removed from his upper lip in Jan-2022. Patient had CT of abdomen and chest every 6 months to make sure everything was clear. On 03-May-2021 Renal Cell Carcinoma and Cyst on Kidney was removed. Patient was initially taking 10 mg of Xeljanz but at the time of reporting he was on 5 mg twice a day for a while and it was maintaining him well. It was reported that In emergency room nebulizer was used to cleared up the lungs. Patient reported that ulcerative colitis was in remission and patient was doing good. Patient had constipated, diarrhea, body went haywire on Cardizem administration and later Cardizem was discontinued. Patient was put back on usual Clonidine 0.2 mg weekly patch and all those problems settled down. Patient was on Prednisone and that made patient's skin sensitive. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.  Company comment: This spontaneous case concerns a 77-year-old male patient with relevant medical history of Ulcerative Colitis and concomitant Tofacitinib citrate (Xeljanz), who experienced the unexpected, serious adverse events of special interest (hospitalization) COVID-19,  and (medically significant) COVID Pneumonia,  and unexpected, serious  (medically significant) event of  Colitis ulcerative (reported as Flare up of Ulcerative Colitis). The event COVID-19 occurred approximately after 4 months, and the events COVID Pneumonia and Colitis ulcerative occurred after 6 months in the context of receiving the 2nd dose of mRNA-1273  vaccination. Patient was hospitalized for 5 days for management of COVID-19 and low electrolytes.  Approximately 2 months later, patient had a computerized tomogram of chest and abdomen which showed findings compatible with COVID Pneumonia, and inflamed diverticulitis (later re-assessed as ulcerative colitis flare up), respectively. Patient  was treated with nebulization and oral Vancomycin for 10 days. Patient received 3 doses of mRNA-1273 vaccine consisting of a 2-dose primary series given 27 days apart, and a booster dose 7 and a half months after. Additionally, Vaccination failure was noted. The relevant medical history of Ulcerative Colitis  remains a confounder as Ulcerative Colitis  is known to result in flares, and the concomitant Tofacitinib citrate, an immunosuppressant, may lower the immune system and immune response to mRNA-1273 vaccine, thus predisposing to infection. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a 77-year-old male patient with relevant medical history of Ulcerative Colitis and concomitant Tofacitinib citrate (Xeljanz), who experienced the unexpected, serious adverse events of special interest (hospitalization) COVID-19,  and (medically significant) COVID Pneumonia,  and unexpected, serious  (medically significant) event of  Colitis ulcerative (reported as Flare up of Ulcerative Colitis). The event COVID-19 occurred approximately after 4 months, and the events COVID Pneumonia and Colitis ulcerative occurred after 6 months in the context of receiving the 2nd dose of mRNA-1273  vaccination. Patient was hospitalized for 5 days for management of COVID-19 and low electrolytes.  Approximately 2 months later, patient had a computerized tomogram of chest and abdomen which showed findings compatible with COVID Pneumonia, and inflamed diverticulitis (later re-assessed as ulcerative colitis flare up), respectively. Patient  was treated with nebulization and oral Vancomycin for 10 days. Patient received 3 doses of mRNA-1273 vaccine consisting of a 2-dose primary series given 27 days apart, and a booster dose 7 and a half months after. Additionally, Vaccination failure was noted. The relevant medical history of Ulcerative Colitis  remains a confounder as Ulcerative Colitis  is known to result in flares, and the concomitant Tofacitinib citrate, an immunosuppressant, may lower the immune system and immune response to mRNA-1273 vaccine, thus predisposing to infection. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.