Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Colitis ulcerative, Computerised tomogram, Influenza, Mass, Pain
Clinical narrative: Ulcerative colitis flared up; CT scan on sternum showed fluid around heart; Lump on chest; Body aches; Flu; This spontaneous case was reported by a consumer and describes the occurrence of COLITIS ULCERATIVE (Ulcerative colitis flared up) and PERICARDIAL EFFUSION (CT scan on sternum showed fluid around heart) in a 39-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Ulcerative colitis.    The patient had no known allergies. The patient had no relevant medical history.  Concurrent medical conditions included Ulcerative colitis (MODERATE TO SEVERE ULCERATIVE COLITIS). Concomitant products included INFLUENZA VACCINE from 24-Dec-2021 to an unknown date for an unknown indication.   In June 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In July 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate free. On 27-Dec-2021, the patient experienced INFLUENZA (Flu). On an unknown date, the patient experienced COLITIS ULCERATIVE (Ulcerative colitis flared up) (seriousness criterion medically significant), PERICARDIAL EFFUSION (CT scan on sternum showed fluid around heart) (seriousness criterion medically significant), MASS (Lump on chest) and PAIN (Body aches). At the time of the report, COLITIS ULCERATIVE (Ulcerative colitis flared up), PERICARDIAL EFFUSION (CT scan on sternum showed fluid around heart), MASS (Lump on chest) and INFLUENZA (Flu) outcome was unknown and PAIN (Body aches) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Computerised tomogram: CT scan on sternum, Fluid around heart.         The Humira formulation was reported as solution for injection in pre-filled pen.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  The reporter causality for events lump on chest and CT scan on sternum showed fluid around heart with with co-suspect Humira was not provided. The reporter causality for events flu, congestion, body aches and ulcerative colitis flared up with co-suspect Humira was no reasonable possibility.  No treatment information was reported.  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 is a spontaneous case, reported by a consumer, concerning a 39-year-old male patient with relevant medical condition of moderate to severe Ulcerative colitis, who experienced the unexpected serious (medically significant) events of Colitis ulcerative reported as ulcerative colitis flared up, and Pericardial effusion confirmed on Chest CT Scan, in the context of the 2-dose primary series of mRNA-1273 vaccine. Latency cannot be properly assessed since the exact vaccination date nor event onset date were provided. Patient had received 2-dose primary series of mRNA-1273 vaccine on unspecified dates. The patient also had chest mass, flu, unspecified congestion and body aches. No further details about the clinical course and treatments were provided. Outcome of the events Colitis ulcerative aggravated and Pericardial effusion were unknown. The condition of moderate to severe Ulcerative colitis remains as a confounder for ulcerative colitis flared up. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This is a spontaneous case, reported by a consumer, concerning a 39-year-old male patient with relevant medical condition of moderate to severe Ulcerative colitis, who experienced the unexpected serious (medically significant) events of Colitis ulcerative reported as ulcerative colitis flared up, and Pericardial effusion confirmed on Chest CT Scan, in the context of the 2-dose primary series of mRNA-1273 vaccine. Latency cannot be properly assessed since the exact vaccination date nor event onset date were provided. Patient had received 2-dose primary series of mRNA-1273 vaccine on unspecified dates. The patient also had chest mass, flu, unspecified congestion and body aches. No further details about the clinical course and treatments were provided. Outcome of the events Colitis ulcerative aggravated and Pericardial effusion were unknown. The condition of moderate to severe Ulcerative colitis remains as a confounder for ulcerative colitis flared up. The benefit-risk relationship of mRNA-1273 is not affected by this report.