Sex: F
Vaccine: COVID19
Symptoms: Weight decreased
Clinical narrative: Sureclick are not as easy to inject/ Sureclick was harder to push the shot; flareup of RA/ lumps on ankles, back of legs, elbows, and fingers. these all appeared in past one year/ hard to use hands due to pain/ could hardly move anymore at that time; lost weight; A1C was going up 10.8 and now is 6.7; This is a solicited report received from contactable reporter (consumer or other non HCP) from License Party. Other Case identifiers: US-AMGEN INC-22-0247559-SR-01, US-AMGEN-USASL2022156830.  This serious solicited report (USASL2022156830) was reported to Agency on 09/SEP/2022 by a consumer from a commercial program and involves a 67 year old female patient who experienced flare up of RA/ lumps on ankles, back of legs, elbows, and fingers. these all appeared in past one year/ hard to use hands due to pain/ could hardly move anymore at that time [PT: rheumatoid arthritis], lost weight [PT: weight decreased], A1c was going up 10.8 and now is 6.7 [PT: glycosylated haemoglobin increased], Sureclick are not as easy to inject/ Sureclick was harder to push the shot [PT: device difficult to use] while receiving Enbrel, Single Dose Prefilled Autoinjector. No historical medical condition was reported. The patient's current medical condition included rheumatoid arthritis. The patient's concomitant medications included methotrexate, Remicade (infliximab).The patient's co-suspect medication included Covid-19 Vaccine. The patient began Enbrel with Single Dose Prefilled Autoinjector on an unknown date in 2000. The patient has been on Enbrel for 22 years but about two years ago patient received covid vaccine. On an unknown date 2021, past one year the patient has developed lumps on ankles, back of legs, elbows and fingers. At this point patient reported hard to use hands due to pain and flareup of RA since her covid vaccines. She reported in the last year of 2021, the patient has lost weight. She reported her A1C was going up 10.8 and now 6.7. Patient stated she changed her diet and activity level to lose weight and better manage her blood sugar. Patient stated now her doctor wanted to switch to another medication. Patient stated she tried Remicade infusion but not sure dose in JAN/2022. Patient stopped Remicade. Patient reported she could hardly move anymore at that time. Patient stated she restarted Enbrel in MAR/2022, that is when she noted SureClick was harder to push the shot. She reported that for past several months, SureClick were not as easy to inject. Patient stated she hits the button and has to keep moving it around in order to get it to work. Patient did not have exact dates but stated she noted this issue since MAR/2022. Patient did not miss a dose and was eventually able to give the injection. No treatment information was received. The outcome of the event glycosylated haemoglobin increased was reported as recovering/resolving. The outcome of the events rheumatoid arthritis, weight decreased, device difficult to use were reported as unknown. Action taken with Enbrel, Single Dose Prefilled Autoinjector was temporarily withheld for the events rheumatoid arthritis, weight decreased and glycosylated haemoglobin increased. The causal relationship between the events rheumatoid arthritis, weight decreased, glycosylated haemoglobin increased, device difficult to use and Enbrel, Single Dose Prefilled Autoinjector was not provided by the consumer. Follow up has been requested.  Agency Comment: This individual case report does not change the safety profile of the product.  The reporter's assessment of the causal relationship of the event with the suspect product etanercept was not provided at the time of this report. Since no determination has been received, the case was managed based on the company causality assessment.  Agency's Causality Assessment: The events Device difficult to use, HbA1C increased, Lost weight and Rheumatoid arthritis flare up are not related to etanercept.  Enbrel is under agreement with Agency.; Sender's Comments: Reported events are considered as intercurrent medical conditions and are therefore not related to the suspect drugs (etanercept and BNT162b2). Case to be re-assessed upon receipt of new information.