Reporte zur Charge FN6208FX

Symptomtext

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. This report received from a contactable consumer (patient). A female patient of an unspecified age received first dose of bnt162b2, intramuscularly on 17Mar2021 (Batch/Lot Number: FN6208FX; Expiration Date: Jun2021) as single dose, second dose intramuscularly on 20Apr2021 (Batch/Lot Number: ER8731) as single dose for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous from 2019 (Batch/Lot number was not reported) to May2021, at 40 mg (1 in 2 weeks), subcutaneous from May2021 (Batch/Lot number was not reported) and ongoing, at 40 mg, weekly (1 in 1 week) for rheumatoid arthritis. Medical history included tobacco Use from an unknown date to 1990 (stopped 1990), alcohol Use from an unknown date to 2000 (stopped 2000), sulfa drugs allergy manifestation by affects liver, methotrexate allergy manifestation by affects liver, anaemia, anxiety, pain, fibromyalgia, heart, restless legs, diabetes. Concomitant medications included metformin taken for diabetes, glipizide (GLIPIZIDE) taken for diabetes, dulaglutide (TRULICITY) taken for diabetes, ropinirole (ROPINIROLE) taken for restless legs, losartan taken for heart, carvedilol taken for heart, cyclobenzaprine taken for fibromyalgia, tramadol taken for pain, duloxetine taken for anxiety, colecalciferol (VITAMIN D), iron taken for anaemia. The patient experienced rheumatoid arthritis flare up on Apr2021, lack of drug effect/humira not working on May2021, elevated sedimentation rate on Apr2021, arthropathy, unspecified, involving shoulder region (sick on shoulder) on Apr2021. Adalimumab (HUMIRA) not working with Humira 40 mg/0.4 ml (Adalimumab). The patient was treated with prednisone. The action taken for adalimumab was dose increased. The outcome of events was not recovered. Causality for Humira 40mg/0.4ml (Adalimumab): The reporter's causality for the event of elevated sedimentation rate was not provided. The reporter's causality for the events of rheumatoid arthritis flare up and sick on shoulder with Humira 40mg/0.4ml (Adalimumab) was no reasonable possibility. The reporter's causality for the event of Humira not working with Humira 40mg/0.4ml (Adalimumab) was a reasonable possibility. Causality with bnt162b2: The reporter's causality for events elevated sedimentation rate and lack of drug effect was not reported, for events Rheumatoid arthritis flare up and Arthropathy, unspecified, involving shoulder region (sick on shoulder) was Possible related. No follow-up attempts are needed. No further information is expected.