Age: 58.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: COVID-19, Gastrointestinal disorder, SARS-CoV-2 test
Clinical narrative: GASTROINTESTINAL SYMPTOMS INCREASING; CAUGHT COVID AFTER SECOND COVID BOOSTER SHOT; This spontaneous case was reported by a consumer and describes the occurrence of GASTROINTESTINAL DISORDER (GASTROINTESTINAL SYMPTOMS INCREASING) and COVID-19 (CAUGHT COVID AFTER SECOND COVID BOOSTER SHOT) in an adult male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.  Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Crohn's disease and Ankylosing spondylitis.  No Medical History information was reported.  On 01-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 17-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) 1 dosage form. On an unknown date, the patient experienced GASTROINTESTINAL DISORDER (GASTROINTESTINAL SYMPTOMS INCREASING) and COVID-19 (CAUGHT COVID AFTER SECOND COVID BOOSTER SHOT). At the time of the report, GASTROINTESTINAL DISORDER (GASTROINTESTINAL SYMPTOMS INCREASING) had not resolved and COVID-19 (CAUGHT COVID AFTER SECOND COVID BOOSTER SHOT) had resolved.  DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) Positive.  No concomitant medications were reported. It was unknown if patient was enrolled in a COVID-19 vaccine trial. The reporter's causality for the events gastrointestinal symptoms increasing and caught COVID after second COVID booster shot with Humira (adalimumab) was a reasonable possibility. No treatment medication was reported.  Company comment: This spontaneous case concerns a male patient, of unknown age, with no reported medical history, who experienced, unexpected, non-serious,f of COVID-19, unspecified days after receiving mRNA-1273 vaccine as a fourth dose. The patient's primary series is mRNA-1273 vaccine and has received third dose of mRNA-1273 as well. On unknown date, the patient underwent SARS-CoV-2 test which showed positive result. Clinical course and treatment details are not available in this report. The event had resolved. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns a male patient, of unknown age, with no reported medical history, who experienced, unexpected, non-serious,  of COVID-19, unspecified days after receiving mRNA-1273 vaccine as a fourth dose. The patient's primary series is mRNA-1273 vaccine and has received third dose of mRNA-1273 as well. On unknown date, the patient underwent SARS-CoV-2 test which showed positive result. Clinical course and treatment details are not available in this report. The event had resolved. The benefit-risk relationship of mRNA-1273 is not affected by this report.