Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Inappropriate schedule of product administration, Pyrexia, Tuberculosis
Clinical narrative: Tuberculosis; Patient administered first dose of moderna on 05-Aug-2021 and second dose on 17-Aug-2021; CHILLS; FEVER; FATIGUE; This spontaneous case was reported by a consumer and describes the occurrence of TUBERCULOSIS (Tuberculosis) in a 66-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) for Rheumatoid arthritis.    No Medical History information was reported.   On 05-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Aug-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,Solution for injection in pre-filled pen. In August 2021, the patient experienced CHILLS (CHILLS), PYREXIA (FEVER) and FATIGUE (FATIGUE). On 17-Aug-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient administered first dose of moderna on 05-Aug-2021 and second dose on 17-Aug-2021). On an unknown date, the patient experienced TUBERCULOSIS (Tuberculosis) (seriousness criterion medically significant). At the time of the report, TUBERCULOSIS (Tuberculosis), CHILLS (CHILLS), PYREXIA (FEVER), FATIGUE (FATIGUE) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient administered first dose of moderna on 05-Aug-2021 and second dose on 17-Aug-2021) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, X-ray: (Negative) CHEST X RAY- Negative.         It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  No concomitant medication were reported.  The reporter's causality for the events of TUBERCULOSIS, CHILLS, FEVER and FATIGUE was not provided. AbbVie's opinion is that the event of TUBERCULOSIS is not assessable. AbbVie's opinion is that there is no reasonable possibility that the events of CHILLS, FEVER and FATIGUE are related to HUMIRA(ADALIMUMAB).  No treatment medication were 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 spontaneous case concerns a 66-year-old male patient, with no reported medical history, treated with co-suspect Adalimumab for rheumatoid arthritis (start date unknown), who experienced the unexpected serious (medically significant) event of Tuberculosis on an unknown date after receiving a dose of mRNA-1273 vaccine. Patient was diagnosed with tuberculosis. Patient received 1st and 2nd doses of mRNA-1273 vaccine 12 days apart and had fever, chills, and fatigue on both vaccines. On unknown date, chest X-ray was done with negative result.Clinical course and treatment details were not reported. The outcome of event was unknown. Co-suspect Adalimumab could be a confounder. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns a 66-year-old male patient, with no reported medical history, treated with co-suspect Adalimumab for rheumatoid arthritis (start date unknown), who experienced the unexpected serious (medically significant) event of Tuberculosis on an unknown date after receiving a dose of mRNA-1273 vaccine. Patient was diagnosed with tuberculosis. Patient received 1st and 2nd doses of mRNA-1273 vaccine 12 days apart and had fever, chills, and fatigue on both vaccines. On unknown date, chest X-ray was done with negative result.Clinical course and treatment details were not reported. The outcome of event was unknown. Co-suspect Adalimumab could be a confounder. The benefit-risk relationship of mRNA-1273 is not affected by this report.