Age: 45.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: COVID-19, Drug ineffective
Clinical narrative: was hospitalized a few day post Covid vaccine and was diagnosed with Covid; was hospitalized a few day post Covid vaccine and was diagnosed with Covid; This is a solicited report from a non-Pfizer sponsored program (marketing program name not available) received from a contactable consumer, based on information received by Pfizer from AMGEN (manufacturer control number US-AMGEN-USASL2021093186), license party for etanercept (ENBREL).   This serious solicited report (USASL2021093186) was reported to Amgen on 15/JUN/2021 by a consumer from a commercial program and involves a 45 year old female patient who was hospitalized a few day post covid vaccine and was diagnosed with covid [PT: COVID-19] while receiving Enbrel, Reusable Autoinjector. No historical medical condition was reported. The patient's current medical condition included rheumatoid arthritis. No concomitant medications were provided. The patient's co-suspect medication included covid-19 vaccine. The patient began Enbrel with Reusable Autoinjector on an unknown date. On 11/MAY/2021, the patient self-administering last Enbrel injection. The patient stated that her HCP (healthcare professional) ordered to held Enbrel injection for one week after receiving the covid-19 vaccine. On an unknown date in MAY/2021, the patient had the covid-19 vaccine administered a couple of days after her last Enbrel injection. The patient stated that she was diagnosed with covid. Subsequently, the patient was hospitalized a few day post covid-19 (corona virus disease-2019) vaccine. The patient received unspecified monoclonal antibody treatment. After a month on an unknown date in JUN/2021, the patient was discharged from the hospital. The patient stated that she was being home for the last "couple of week. The patient stated that the HCP discontinued Enbrel injection treatment at this time. The outcome of the event COVID-19 was reported as unknown. The causal relationship between the event COVID-19 and Enbrel, Reusable Autoinjector was not provided by the consumer. The reporter did not and would never have access to lot number. No further information has been requested.  Amgen comment: This safety report does not necessarily reflect a conclusion by Amgen that etanercept caused or contributed to the adverse event reported; however, consistent with regulatory reporting requirements, this case is being reported because it contains one or more suspected adverse reaction. This individual report does not change the safety profile of the product.  Causality Assessment for event COVID-19 Per Amgen = yes  The reporter's assessment of the causal relationship of the event with the suspect product 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.  No follow-up attempts are possible; information about lot/batch number cannot be obtained; Reporter's Comments: ~~~; Sender's Comments: Based on the available information and known product profile, the causal relationship between the event covid 19 and the use of BNT162B2 is possible under the context of  lack of efficacy.  Based on the available information and known product profile, the causal relationship between the event covid 19 and the use of etanercept  cannot be excluded.