Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Injection site pain, SARS-CoV-2 test
Clinical narrative: Patient reports that she has been off her Enbrel for over a month after contacting Covid after receiving the Covid vaccine; Patient reports that she has been off her Enbrel for over a month after contacting Covid after receiving the Covid vaccine; previous Enbrel injections in her leg "hurt; This is a solicited report from a non-Pfizer sponsored program (marketing program name not available) from a contactable consumer, based on information received by Pfizer from Amgen (manufacturer control number: US-AMGEN-USASL2021118412), license party for etanercept. This serious solicited report (USASL2021118412) was reported to Amgen on 30/JUL/2021 by a consumer from a commercial program (PSP00086) and involves a 61 year old female patient who experienced patient reports that she has been off her Enbrel for over a month after contacting covid after receiving the covid vaccine [PT: covid-19], previous Enbrel injections in her leg hurt [PT: injection site pain] while receiving Enbrel with 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 Covid-19 Vaccine. No co-suspect medications were reported. The patient began Enbrel with Single Dose Prefilled Autoinjector on an unknown date. On an unknown date, the patient's previous Enbrel injections in her leg hurt. On an unknown date, the patient contracted Covid (corona virus disease) after receiving the covid vaccine and subsequently had been off her Enbrel for over a month. The patient was hospitalized with symptoms of severe fever, weight loss and difficulty breathing. No treatment information was received. The outcome of the events covid-19, injection site pain was reported as unknown. Action taken with Enbrel and Single Dose Prefilled Autoinjector was temporarily withheld for the event covid-19. Action taken with Enbrel with Single Dose Prefilled Autoinjector was reported as unknown for the event injection site pain.  The causal relationship between the events covid-19, injection site pain and Enbrel with Single Dose Prefilled Autoinjector was not provided by the consumer. The patient cannot read/cannot find lot number. The reporter declined consent for follow up. No follow up attempts are possible. No further information is expected.  Amgen comment: This safety report does not necessarily reflect a conclusion by Amgen that etanercept caused or contributed to the adverse events reported; however, consistent with regulatory reporting requirements, this case is being reported because it contains one or more suspected adverse reactions. This individual case report does not change the safety profile of the product.  The reporter's assessment of the causal relationship of the events with the suspect products 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.; Sender's Comments: The contributory role of the suspect product BNT162B2 to the reported drug ineffective cannot be excluded as the efficacy of a drug varies individually and may be affected by different factors including drug potency. The events Drug ineffective, Covid-19, and Injection site pain are considered intercurrent conditions and unrelated to Etanercept.