Sex: F
Vaccine: COVID19, UNK
Symptoms: Drug level decreased, Headache
Clinical narrative: Low drug level; Headache; This spontaneous case was reported by a patient and describes the occurrence of DRUG LEVEL DECREASED (Low drug level) and HEADACHE (Headache) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Psoriatic arthritis and Rheumatoid arthritis.    No Medical History information was reported.   On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 22-Oct-2021, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate Free. On an unknown date, the patient experienced DRUG LEVEL DECREASED (Low drug level) and HEADACHE (Headache). At the time of the report, DRUG LEVEL DECREASED (Low drug level) had not resolved and HEADACHE (Headache) outcome was unknown.            Concomitant medications were not reported.  It was unknown if patient was enrolled in a COVID-19 vaccine trial.  It was reported that the patient experienced Humira was low in blood.  The reporter's causality for the event of headache with HUMIRA (ADALIMUMAB) was no reasonable possibility.  Treatment medications were not reported. Company Comment: This spontaneous case concerns a female  patient with unknown age , with no medical history reported , with Co-suspect non-company product ADALIMUMAB (HUMIRA) for Psoriatic arthritis and Rheumatoid arthritis , w   who experienced non-serious , unexpected event of Drug level decreased ( Low drug level , HUMIRA WAS LOW IN BLOOD )  and non-serious , expected event of headache . These events occurred on an unknown date post vaccination with the dose1 and dose 2 of mRNA-1273 vaccine. The details surrounding the events 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 events was reported as unknown.  The co-suspect non-company drug Adalimumab ( Humira ) is considered as confounder for the events. 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 female  patient with unknown age , with no medical history reported , with Co-suspect non-company product ADALIMUMAB (HUMIRA) for Psoriatic arthritis and Rheumatoid arthritis , with no medical history reported,   who experienced non-serious , unexpected event of Drug level decreased ( Low drug level , HUMIRA WAS LOW IN BLOOD )  and non-serious , expected event of headache . These events occurred on an unknown date post vaccination with the dose1 and dose 2 of mRNA-1273 vaccine. The details surrounding the events 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 events was reported as unknown.  The co-suspect non-company drug Adalimumab ( Humira ) is considered as confounder for the events. The benefit -risk relationship of mRNA -1273 ( Moderna Covid 19 Vaccine) is not affected by this report.