Sex: F
Vaccine: COVID19
Symptoms: Endometrial ablation, Fatigue, Illness, Product dose omission issue, Rheumatoid arthritis
Clinical narrative: Diagnosed with another auto immune issue; Sick/very sick"; Poor eye sight and astigmatism whole life and that it is worse when trying to read things up close/ Eye sight gets a little worse every year; basal cell carcinoma removed off her left arm and left shoulder/She had two procedures related to "removal of the basal skin cancer in 2020/had skin cancer; missed dose of Enbrel.; flare up due to high stress/painful flare ups; COVID virus/ COVID; loss of appetite and fatigue about 4-6 months after having COVID-19; loss of appetite and fatigue about 4-6 months after having COVID-19; patient reports having "bronchitis back in 2019".; she had a uterine ablation; This is a solicited report received from a Consumer or other non HCP from License Party. Other Case identifier(s): US-AMGEN INC-22-0043906-SR-01, US-AMGEN INC-22-0193572-SR-01, US-AMGEN INC-23-0130395-SR-01, US-AMGEN INC-24-0197975-SR-01, US-AMGEN INC-24-0198088-SR-01, US-AMGEN-USASL2022025417.  This serious solicited report was reported to Agency on 11Feb2022 by a consumer from a commercial program and involves a 47 year old female patient who experienced flare up due to high stress [PT: rheumatoid arthritis], COVID (Coronavirus disease) virus [PT: COVID-19] while receiving Enbrel. No historical medical condition was reported. The patient's current medical condition included rheumatoid arthritis. No concomitant medications were provided. No co-suspect medications were reported. The patient began Enbrel on an unknown date. On an unknown date in Feb2022, she just got over COVID (Coronavirus disease) virus about a week ago and still had some lingering symptoms. On 11Feb2022, patient reported now she was experiencing a flare up due to high stress and says that was when flare ups happen for her. The patient reported Enbrel works really well for her and had given her a new way of life. No treatment information was received. The outcome of the events rheumatoid arthritis and COVID-19 was reported as not recovered/not resolved. Action taken with Enbrel was reported as unknown for the events COVID-19 and rheumatoid arthritis.  The causal relationship between the events COVID-19, rheumatoid arthritis and Enbrel was not provided by the consumer. The reporter could not read/could not find lot number. The reporter declined consent for follow up.  Agency Causality Assessment: COVID-19, Rheumatoid arthritis flare up were not related to Enbrel.  Agency comments: This individual case report does not change the safety profile of the product.  Etanercept (ENBREL) is under agreement with Agency.  Follow-up (13Jul2022): This is a solicited follow-up report received from a contactable Consumer from License Party. Other Case identifier(s): US-AMGEN INC-22-0193572-SR-01, US-AMGEN-USASL2022025417.  ADDITIONAL INFORMATION RECEIVED 13Jul2022: Upon follow up information event onset date was updated for previously reported event [PT: COVID-19]. The follow up information was from a commercial program and patient who experienced flare up due to high stress [PT: rheumatoid arthritis], Coronavirus disease (COVID) virus/ COVID [PT: COVID-19], sick [PT: illness], poor eye sight and astigmatism whole life and that it is worse when trying to read things up close/ eye sight gets a little worse every year [PT: visual impairment] while receiving Enbrel, Reusable Autoinjector. The patient's current medical condition included poor eye sight. The patient began Enbrel, Reusable Autoinjector on an unknown date in 2016. On an unknown date, the patient also mentioned that she had poor eye sight when asked to read the serial number off of her autotouch device. This writer asked the patient if she always had bad eyesight or if had changed at all since starting Enbrel. The patient stated that she has always had bad eye sight and astigmatism her whole life and that it was worse when trying to read things up close. However, the patient stated that she went once a year to the physician and she always needed a new prescription each year stating that her eye sight got a little worse every year. On an unknown date, the patient had missed one dose over the past couple of years when she was sick and that her HCP was aware but she didn't have an exact date for that. On an unknown date in Jan2022, the patient had Coronavirus disease (COVID). Therefore the patient had missed a dose or two of her Enbrel the advised of her HCP (Healthcare professional). The outcome of the events illness, visual impairment were reported as unknown. Action taken with Enbrel and Reusable Autoinjector was temporarily withheld for the events COVID-19 and illness. Action taken with Enbrel and Reusable Autoinjector was reported as unknown for the events COVID-19, rheumatoid arthritis, illness, visual impairment. The causal relationship between the events COVID-19, rheumatoid arthritis, illness, visual impairment and Enbrel, Reusable Autoinjector was not provided by the consumer. No further information has been requested.  Agency Causality Assessment: COVID-19, Rheumatoid arthritis flare up, Visual impairment were unrelated to etanercept while sickness was related to etanercept.  Agency comment: This individual case report does not change the safety profile of the product.  Enbrel is under agreement with Agency.  Follow up (10May2023): This is a solicited follow up report received from contactable consumer from License Party. Other Case identifier: US-AMGEN INC-23-0130395-SR-01, US-AMGEN-USASL2022025417.  ADDITIONAL INFORMATION RECEIVED ON 10May2023: This follow-up information was reported to Agency by a consumer from a commercial program and involves a patient who had painful flare ups [PT: rheumatoid arthritis], diagnosed with another auto immune issue [PT: autoimmune disorder] while receiving Enbrel, Reusable Autoinjector, Single Dose Prefilled Autoinjector. The patient's current medical condition included moderate to severe rheumatoid arthritis. Patient beginning formulation updated. The patient began Enbrel with unknown formulation on an unknown date in 2016 and started using Enbrel with Reusable Autoinjector on an unknown date. The patient switched to Enbrel, Single Dose Prefilled Autoinjector on 01Dec2017. The patient's Enbrel was helping however on an unknown date she had been diagnosed with another auto immune issue and since she did experience painful flare ups. She could not actually determine if it was from the Arthritis or other immune issue. The outcome of the events rheumatoid arthritis, autoimmune disorder was reported as unknown. Action taken with Enbrel, Single Dose Prefilled Autoinjector was continued for the events rheumatoid arthritis and autoimmune disorder. Action taken with Reusable Autoinjector was reported as unknown for the event autoimmune disorder. Action taken with Single Dose Prefilled Autoinjector was reported as unknown for the events covid-19 and visual impairment. The causal relationship between the event autoimmune disorder and Enbrel, Reusable Autoinjector was not provided by the consumer. The causal relationship between the events covid-19, rheumatoid arthritis, illness, visual impairment, autoimmune disorder and Single Dose Prefilled Autoinjector was not provided by the consumer. The reporter did not and would never have access to lot number. The reporter declined consent for follow up. No follow up attempts are possible. No further information is expected.  The reporter's assessment of the causal relationship of "flare up due to high stress/painful flare ups", "diagnosed with another auto immune issue", "sick", "covid virus/ covid" and "poor eye sight and astigmatism whole life and that it is worse when trying to read things up close/ eye sight gets a little worse every year" with the suspect product(s) etanercept was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  Agency causality assessment: The events Autoimmune disorder, Visual impairment, Rheumatoid arthritis flare up, COVID-19 were assessed Unrelated (NO) and event sickness was assessed as related (Yes) to enbrel.  Agency Comments: This individual case report does not change the safety profile of the product.  Enbrel is under agreement with Agency.  Follow-up (10Jul2024): This is a solicited follow-up report received from a Consumer or other non HCP from License Party. Other Case identifier(s): US-AMGEN INC-22-0043906-SR-01, US-AMGEN INC-22-0193572-SR-01, US-AMGEN INC-23-0130395-SR-01, US-AMGEN INC-24-0197975-SR-01, US-AMGEN INC-24-0198088-SR-01, US-AMGEN-USASL2022025417.  ADDITIONAL INFORMATION RECEIVED ON 10/JUL/2024: In this follow up report patient's age has been updated to approximately 45year. It was reported that the patient had a uterine ablation [PT: endometrial ablation], basal cell carcinoma removed off her left arm and left shoulder/she had two procedures related to removal of the basal skin cancer in 2020/had skin cancer [PT: basal cell carcinoma], covid [PT: covid-19], bronchitis back in 2019 [PT: bronchitis], loss of appetite and fatigue about four to six months after having covid-19 [PT: fatigue and PT: decreased appetite], missed dose of Enbrel. [PT: product dose omission issue] while receiving Enbrel with Reusable Autoinjector, Single Dose Prefilled Autoinjector. The patient's current medical condition included rheumatoid arthritis. The patient's co-suspect medication included Covid-19 Vaccine. The patient began Enbrel with unknown formulation on an unknown date in 2016 and started using Enbrel with Reusable Autoinjector on an unknown date. The patient switched to Enbrel with Single Dose Prefilled Autoinjector on 01/DEC/2017. Later on an unknown date, the patient was back to Enbrel with Reusable Autoinjector. On an unknown date, the patient also had skin cancer. The patient was required to take the COVID-19 vaccine due to work and mentioned the second booster made her very sick. The patient could not recall when this occurred. On an unknown date in 2019, the patient had a uterine endometrial ablation. On an unknown date in 2019, the patient had mild case bronchitis. On an unknown date in 2020, she had two procedures related to removal of the basal skin cancer. The patient was having basal cell carcinoma removed off her left arm and left shoulder. The patient reported that missing two weeks of Enbrel for each surgery. On an unknown date in JAN/2022, the patient had COVID-19. On an unknown date in 2022, the patient was having a loss of appetite and fatigue about four to six months after having COVID-19. Again in AUG/2023, the patient had COVID-19. On 10/JUL/2024, the patient missed dose of Enbrel. The outcome of the events fatigue, decreased appetite were reported as recovered/resolved. The outcome of the events endometrial ablation, basal cell carcinoma, bronchitis, product dose omission issue were reported as unknown. The events fatigue, decreased appetite were resolved on an unknown date in 2022. Action taken with Enbrel was reported as unknown for the events bronchitis, fatigue, decreased appetite, endometrial ablation. Action taken with Reusable Autoinjector was reported as unknown for the events fatigue, decreased appetite and basal cell carcinoma. Action taken with Single Dose Prefilled Autoinjector was reported as unknown for the events bronchitis, endometrial ablation. Action taken with Enbrel with Single Dose Prefilled Autoinjector was reported as temporarily withheld on an unknown date in 2020 for the event basal cell carcinoma. The causal relationship between the events bronchitis, fatigue, decreased appetite, endometrial ablation, basal cell carcinoma, product dose omission issue and Enbrel, Reusable Autoinjector, Single Dose Prefilled Autoinjector was not provided by the consumer. Follow up has been requested.  The reporter's assessment of the causal relationship of "flare up due to high stress/painful flare ups", "diagnosed with another auto immune issue", "sick/very sick"", "covid virus/ covid", "poor eye sight and astigmatism whole life and that it is worse when trying to read things up close/ eye sight gets a little worse every year", "she had a uterine ablation", "basal cell carcinoma removed off her left arm and left shoulder/she had two procedures related to "removal of the basal skin cancer in 2020/had skin cancer", "patient reports having "bronchitis back in 2019"." and "loss of appetite and fatigue about 4-6 months after having covid-19" with the suspect product(s) COVID-19 Vaccine - Manufacturer Unknown and etanercept was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  Agency Causality Assessment: The events Missed dose, Basal cell carcinoma, Uterine ablation, Appetite lost, Fatigue, Autoimmune disorder, Visual impairment, Rheumatoid arthritis flare up, and COVID-19' were assessed as unrelated to etanercept; and the events Bronchitis and Sickness were assessed as related to etanercept.  Agency Comment: This individual case report does not change the safety profile of the product.     Enbrel is under agreement with Agency.; Sender's Comments: Based on temporal association, the events sickness and bronchitis are considered as related to etanercept and the Covid-19 vaccine. Other events are considered unrelated to etanercept and Covid-19 vaccine, but due to underlying disease or represented intercurrent medical condition. Based on the information received in the FU, event Autoimmune disorder was likely an intercurrent or underlying condition in the patient and assessed as not related to etanercept use. The impact of this report on the benefit-risk profile of the Pfizer product and on the conduct of the study is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.