Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Bronchitis, COVID-19, Inappropriate schedule of product administration, Sinusitis
Clinical narrative: Bronchitis; Sinusitis; two doses of mRNA-1273 were given on a 92-day interval; COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19), BRONCHITIS (Bronchitis), SINUSITIS (Sinusitis) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (two doses of mRNA-1273 were given on a 92-day interval) in a 54-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 02-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Sep-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 02-Sep-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (two doses of mRNA-1273 were given on a 92-day interval). In September 2021, the patient experienced COVID-19 (COVID-19). On an unknown date, the patient experienced BRONCHITIS (Bronchitis) and SINUSITIS (Sinusitis). At the time of the report, COVID-19 (COVID-19), BRONCHITIS (Bronchitis), SINUSITIS (Sinusitis) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (two doses of mRNA-1273 were given on a 92-day interval) outcome was unknown.            Relevant concomitant medications were not reported.  Treatment information was not provided. The reporter's causality for the events of COVID-19, BRONCHITIS and SINUSITIS was not provided for HUMIRA(ADALIMUMAB).  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 concerning a 54-year-old female patient with no relevant medical history, who experienced the unexpected, non-serious adverse event of special interest of COVID-19, approximately within the same month after receiving the second dose of mRNA-1273 vaccine. Exact onset date of the event, clinical course, diagnostic tests and treatment details were not provided in the case. The outcome of the event was unknown at the time of the report. Inappropriate schedule of product administration was also reported as an additional event as the two doses of mRNA-1273 were given on a 92-day interval. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a 54-year-old female patient with no relevant medical history, who experienced the unexpected, non-serious adverse event of special interest of COVID-19, approximately within the same month after receiving the second dose of mRNA-1273 vaccine. Exact onset date of the event, clinical course, diagnostic tests and treatment details were not provided in the case. The outcome of the event was unknown at the time of the report. Inappropriate schedule of product administration was also reported as an additional event as the two doses of mRNA-1273 were given on a 92-day interval. The benefit-risk relationship of mRNA-1273 is not affected by this report.