Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. In 2021, the patient experienced COVID-19 (COVID-19) (seriousness criterion hospitalization). At the time of the report, COVID-19 (COVID-19) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, SARS-CoV-2 test: (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. No concomitant medication information was reported. No treatment medication 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.  CC: This spontaneous case concerns an 82-year-old, female patient with a concurrent condition of rheumatoid arthritis treated with adalimumab, who experienced an unexpected, serious AESI COVID-19 in association with a 1st dose of mRNA-1273 vaccine that led to hospitalization. Exact latency of the event COVID-19 relative to vaccination cannot be determined with an unknown event's onset date and vaccination date. Patient reported feeling unwell on an unknown date. A COVID-19 test positive was obtained on an unknown date. Outcome of the event COVID-19 was reported as not resolved. Further details on the medical history, clinical course, diagnostics, and treatments were not reported. Patient's elderly age, underlying rheumatoid arthritis, and treatment with adalimumab could be considered predisposing risk factors to various infectious diseases. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event's seriousness assessed based on medical judgement and the available information.; Sender's Comments: This spontaneous case concerns an 82-year-old, female patient with a concurrent condition of rheumatoid arthritis treated with adalimumab, who experienced an unexpected, serious AESI COVID-19 in association with a 1st dose of mRNA-1273 vaccine that led to hospitalization. Exact latency of the event COVID-19 relative to vaccination cannot be determined with an unknown event's onset date and vaccination date. Patient reported feeling unwell on an unknown date. A COVID-19 test positive was obtained on an unknown date. Outcome of the event COVID-19 was reported as not resolved. Further details on the medical history, clinical course, diagnostics, and treatments were not reported. Patient's elderly age, underlying rheumatoid arthritis, and treatment with adalimumab could be considered predisposing risk factors to various infectious diseases. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event's seriousness assessed based on medical judgement and the available information.