Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Inappropriate schedule of product administration
Clinical narrative: Covid-19; Administered first dose on 15-Oct-2021 and second dose on 02-Nov-2021; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Covid-19) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Administered first dose on 15-Oct-2021 and second dose on 02-Nov-2021) in a 44-year-old 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 Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis.   On 15-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Nov-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 05-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) Citrate free. On 02-Nov-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Administered first dose on 15-Oct-2021 and second dose on 02-Nov-2021). In 2022, the patient experienced COVID-19 (Covid-19). At the time of the report, COVID-19 (Covid-19) was resolving and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Administered first dose on 15-Oct-2021 and second dose on 02-Nov-2021) outcome was unknown.            No concomitant medication was reported.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  No treatment medication was provided.  Company Comment: This spontaneous case concerns a 44 year old male patient , with no medical history reported , with Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis, who experienced non-serious , unexpected , AESI of Covid 19  which occurred on an unknown date in 2022 post vaccination with the dose 1 , 2 and 3 of mRNA-1273 vaccine . Event of inappropriate schedule of product administration was also reported . Treatment information , results of laboratories/diagnostic procedures were not reported and there was no report if any medical consult was done. Outcome of the events  was unknown. The co-suspect drug ADALIMUMAB (HUMIRA, causing immunosuppression )  and the ongoing Covid 19 pandemic are considered as confounders for the event Covid 19 . The benefit -risk relationship of mRNA -1273 ( Moderna Covid 19 Vaccine) is not affected by this report.   This case was linked to MOD-2022-628125 (Patient Link).; Sender's Comments: This spontaneous case concerns a 44 year old male patient , with no medical history reported , with Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis, who experienced non-serious , unexpected , AESI of Covid 19  which occurred on an unknown date in 2022 post vaccination with the dose 1 , 2 and 3 of mRNA-1273 vaccine . Event of inappropriate schedule of product administration was also reported . Treatment information , results of laboratories/diagnostic procedures were not reported and there was no report if any medical consult was done. Outcome of the events  was unknown. The co-suspect drug ADALIMUMAB (HUMIRA, causing immunosuprresion )  and the ongoing Covid 19 pandemic are considered as confounders for the event Covid 19 . The benefit -risk relationship of mRNA -1273 ( Moderna Covid 19 Vaccine) is not affected by this report.