Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Investigation, Investigation abnormal, SARS-CoV-2 test
Clinical narrative: Increased vector score; COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of INVESTIGATION ABNORMAL (Increased vector score) and COVID-19 (COVID-19) in a 52-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) solution for injection for Rheumatoid arthritis.    There was no medical history reported.  Concurrent medical conditions included Rheumatoid arthritis.   On 18-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 11-Dec-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 started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. In June 2022, the patient experienced COVID-19 (COVID-19). On an unknown date, the patient experienced INVESTIGATION ABNORMAL (Increased vector score). The patient was treated with ABATACEPT (ORENCIA) at an unspecified dose and frequency. At the time of the report, INVESTIGATION ABNORMAL (Increased vector score) outcome was unknown and COVID-19 (COVID-19) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In June 2022, SARS-CoV-2 test: positive (Positive) Positive. On an unknown date, Investigation: increased Investigation abnormal, vector score increased, Vector score went from 36-40.     mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was withdrawn on an unknown date.       No concomitant medications were reported by the reporter.  Humira was given for an indication with moderate to severe rheumatoid arthritis.  Relevant laboratory and other diagnostics test include vector score went from 36 to 40.  It was reported that on unknown date patient experienced increased vector score. It was unknown if patient was enrolled in a COVID-19 vaccine clinical trial.  The reporter causality of Humira (Adalimumab) for the events of increased vector score and COVID  was not provided/not reported.  Company comment-This spontaneous case concerns a female patient aged 52 years with no relevant medical history reported, who experienced the unexpected non serious AESI of Covid 19 on an unknown date after receiving the 3rd dose of mRNA-1273 vaccine in the covid 19 vaccination series. Investigation abnormal (reported as vector score increased) was also noted, Vector score went from 36-40. Outcome of the event  Covid 19 was resolving at the time of the report. No further details on clinical course, other lab test results and treatment received were reported. Ongoing pandemic remains as a confounder to the event Covid 19. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event seriousness assessed as per medical judgement.; Sender's Comments: This spontaneous case concerns a female patient aged 52 years with no relevant medical history reported, who experienced the unexpected non serious AESI of Covid 19 on an unknown date after receiving the 3rd dose of mRNA-1273 vaccine in the covid 19 vaccination series. Investigation abnormal (reported as vector score increased) was also noted, Vector score went from 36-40. Outcome of the event  Covid 19 was resolving at the time of the report. No further details on clinical course, other lab test results and treatment received were reported. Ongoing pandemic remains as a confounder to the event Covid 19. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event seriousness assessed as per medical judgement.