Sex: F
Vaccine: COVID19, UNK
Symptoms: Arthropathy, Blood test, Laboratory test, Rheumatoid arthritis, Therapeutic product effect decreased
Clinical narrative: Humira not working with BNT162B2; Rheumatoid arthritis flare up; Elevated sedimentation rate; Arthropathy, unspecified, involving shoulder region/Sick on shoulder; This is a spontaneous report based on the information received by Pfizer from a regulatory authority (MFR Control No. 21K-163-4110655-00) via a contactable consumer (patient) reported for herself. A female patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: ER8731, Expiration date: unknown) intramuscular, administered at an unspecified anatomical location on 20Apr2021 (age at vaccination was unknown) as dose 2, single for COVID-19 immunization. The patient's medical history included tobacco use from an unknown date to 1990, alcohol use from an unknown date to 2000, ongoing diabetes, ongoing restless legs, ongoing heart, ongoing fibromyalgia, ongoing pain, ongoing anxiety, ongoing anemia and ongoing rheumatoid arthritis. Concomitant medications included metformin taken for diabetes, glipizide taken for diabetes, dulaglutide (TRULICITY) taken for diabetes, ropinirole taken for restless legs, losartan taken for cardiac disorder, carvedilol taken for heart, cyclobenzaprine taken for fibromyalgia, tramadol taken for pain, duloxetine taken for anxiety, colecalciferol (VITAMIN D [COLECALCIFEROL]) taken for an unknown indication and iron taken for anemia. The co-suspect medication included adalimumab (HUMIRA), subcutaneous from 2019 to May2021, at 40 mg (1 in 2 week) (Batch/Lot number was not reported) and subcutaneous from May2021 and ongoing, at 40 mg (1 in 1 week) (Batch/Lot number was not reported) for rheumatoid arthritis. The patient previously took methotrexate for unknown indication and experienced Methotrexate allergy manifestation by affects liver, sulfa [sulfanilamide] and experienced Sulfa drugs allergy manifestation by affects liver. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: FN6208FX, Expiration date: Jun2021) intramuscular, administered at an unspecified anatomical location on 17Mar2021 (age at vaccination was unknown) as dose 1, single for COVID-19 immunization. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. On an unspecified date in Apr2021, the patient experienced rheumatoid arthritis flare up, elevated sedimentation rate, and arthropathy, unspecified, involving shoulder region/sick on shoulder. In May2021, Humira was not working with humira 40mg/0.4ml (adalimumab) and there was a lack of drug effect. COVID-19 vaccine was also considered suspect. The patient was treated with prednisone. The patient underwent lab tests which included blood test: elevated sedimentation rate on an unspecified date in Apr2021, lab test: abnormal on an unspecified date and sedimentation rate: elevated on an unspecified date in Apr2021. The action taken with humira 40mg/0.4ml(adalimumab) due to the events was dose increased. The reporter's causality for the event of elevated sedimentation rate with humira 40mg/0.4ml(adalimumab) was not provided. The reporter's causality for the event of rheumatoid arthritis flare up and sick on shoulder with humira 40mg/0.4ml (adalimumab) was no reasonable possibility. The reporter's causality for humira not working with humira 40mg/0.4ml(adalimumab) was a reasonable possibility. The reporter's causality for the event of elevated sedimentation rate BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) was not provided. The reporter's causality for the event of rheumatoid arthritis flare up and sick on shoulder with BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) was reported as possible. The reporter's causality for humira not working with BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) was not reported. The outcome of the events was not resolved.