Sex: F
Vaccine: COVID19
Symptoms: Arthritis infective, Lack of injection site rotation
Clinical narrative: using a walker due to a knee issue/ using a walker due to knee infection/ wash out procedure for infection of right knee/was in hospital for 4 nights/knee replacement; she always gives injection in abdomen; This is a solicited report received from a Consumer or other non HCP from License Party. Other Case identifiers: US-AMGEN INC-24-0009603-SR-01, US-AMGEN-USASL2024005913.  This serious solicited report (USASL2024005913) was reported to company on 10Jan2024 by a consumer from a commercial program and involves a 77 year old female patient who was using a walker due to a knee issue/ using a walker due to knee infection/ wash out procedure for infection of right knee/was in hospital for four nights/knee replacement [PT: arthritis infective], she always gave injection in abdomen [PT: lack of injection site rotation], had COVID vaccine but ended up with a reaction with symptoms that lasted for six months/she was getting steroid shot for symptoms for six months relating to symptoms [PT: adverse reaction] while receiving Enbrel with Single Dose Prefilled Autoinjector. No historical medical condition was reported. The patient's current medical condition included psoriasis arthritis. The patient's concomitant medications included Rsv Vaccine. The patient's co-suspect medication included COVID-19 Vaccine, unspecified steroid injection. The patient began Enbrel with Single Dose Prefilled Autoinjector on an unknown date. Since on an unknown date, the patient always gave injection in abdomen and she would see a tiny drop of medication on the injection site. On an unknown date, the patient had COVID vaccine but ended up with a reaction with symptoms that lasted for six months. She got steroid shot for symptoms for six months relating these symptoms. On an unknown date, the patient had knee infection which resulted from a steroid injection she received in the right knee. She got steroid injection in both knees and stated she had many of those over the years. She was using a walker due to knee issue and could not go to get the sureclicks. On 31Jul2023, the patient had wash out procedure for infection of right knee. On an unknown date in 2023, she was in the hospital for four nights and then had to get IV (Intravenous) antibiotics for 30 days at a rehab. She also had to be seen two times a week by her orthopedic surgeon for a month. On an unknown date in Dec2023, two weeks ago, she got RSV vaccine. On 31Dec2023, Sunday, a week ago, the patient took an injection, the yellow part came down but it never clicked to let her know it was finished. Again on 07Jan2024, Sunday, same thing happened. She could not tell if it had been injected with the medication or not. This happened with two sureclicks of which she had thrown away one sureclick but still had one which was used. There had been a second click at the end of the injection in the past. She always gave injection in abdomen but she did not saw an injection mark at the injection site. She would see a tiny drop of medication on the injection site. For the past two times though, she heard and saw nothing. She spoke with someone about a faulty sureclicks and she was told she would get sureclicks but had not received the sureclicks nor heard from anyone. The patient was scheduled for knee replacement on 19Jan2024 but was postponed in the next couple of months because she wanted to wait until COVID, RSV, flu have decreased in occurrence. The outcome of the event adverse reaction was reported as recovered/resolved. The outcome of the events arthritis infective, lack of injection site rotation was reported as unknown. The event adverse reaction was resolved on an unknown date. Action taken with Enbrel and Single Dose Prefilled Autoinjector was reported as unknown for the events lack of injection site rotation, arthritis infective, adverse reaction. The causal relationship between the events lack of injection site rotation, arthritis infective, adverse reaction and Enbrel with Single Dose Prefilled Autoinjector was not provided by the consumer. Follow up has been requested. Lot number has been requested.  Company Comment: This safety report does not necessarily reflect a conclusion by conpany 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.  Causality Assessment per Company: Adverse reaction, Lack of injection site rotation are not related to etanercept. Joint infection is related to etanercept.  Amendment: This follow-up report is being submitted to allow appropriate reporting to US FDA with the correct Emergency Use Authorization number 027034 for BNT162B2.  Enbrel is under agreement with company.; Sender's Comments: Event joint infection is assessed related to Enbrel based on drug safety profile. Other reported events are not related to Enbrel and covid vaccine. Joint infection is not related to covid vaccine.