Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19) in a 76-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. No Medical History information was reported. In 2019, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 40 milligram every two weeks. On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In December 2021, the patient experienced COVID-19 (COVID-19). At the time of the report, COVID-19 (COVID-19) outcome was unknown. No concomitant products were reported. No treatment information was provided. It was unknown whether patient enrolled in COVID-19 vaccine trial. Company Comment: This spontaneous case concerns a 76 year old female patient with no medical history reported, with reported Co-suspect drug ADALIMUMAB (HUMIRA) (Subcutaneous) 40 milligram every two weeks since 2019 (indication not reported), who experienced Non-serious, unexpected, AESI of Covid-19 which occurred on an unknown date in 2021 Dec. post vaccination with the dose 1, dose 2 and dose 3 of mRNA-1273 vaccine (date of vaccination not reported). This patient reported on an unknown date the potential overuse/partial injecting then took another dose as unsure how much got with first one with the co-suspect drug ADALIMUMAB (HUMIRA). The details surrounding the event Covid-19 like treatment information, results of laboratories/diagnostic procedures were not reported and there was no report if any medical consult was done. Outcome of the event Covid-19 was unknown, The age of this patient and the Co-suspect drug ADALIMUMAB are considered as confounders for the event. The benefit -risk relationship of mRNA -1273 (Moderna Covid-19 Vaccine) is not affected by this report. Sender's Comments: This spontaneous case concerns a 76 year old female patient with no medical history reported, with reported Co-suspect drug ADALIMUMAB (HUMIRA) (Subcutaneous) 40 milligram every two weeks since 2019 (indication not reported), who experienced Non-serious, unexpected, AESI of Covid-19 which occurred on an unknown date in 2021 Dec. post vaccination with the dose 1, dose 2, and dose 3 of mRNA-1273 vaccine (date of vaccination not reported). This patient reported on an unknown date the potential overuse/partial injecting then took another dose as unsure how much got with first one with the co-suspect drug ADALIMUMAB (HUMIRA). The details surrounding the event Covid-19 like treatment information, results of laboratories/diagnostic procedures were not reported and there was no report if any medical consult was done. Outcome of the event Covid-19 was unknown, The age of this patient and the Co-suspect drug ADALIMUMAB are considered as confounders for the event. The benefit -risk relationship of mRNA -1273 (Moderna Covid-19 Vaccine) is not affected by this report.