Sex: M
Vaccine: COVID19
Symptoms: Dermatitis infected
Clinical narrative: Infected rash on thigh that worsened with covid vaccine; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program.  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "Rheumatoid arthritis" (ongoing); "Bruising" (ongoing). Concomitant medication(s) included: ENBREL taken for rheumatoid arthritis, start date: 2002; ENBREL, stop date: 2021; ENBREL, start date: 2021. The following information was reported: DERMATITIS INFECTED (non-serious), outcome "not recovered", described as "Infected rash on thigh that worsened with covid vaccine". Additional information: Adult male patient experienced left ear keep clogging up, pain and stinging he felt from the injections, the tube going from his ear is not working correctly, only injects in his abdomen while receiving Enbrel, Single Dose Prefilled Syringe, Multiple Dose Vial Kit For Reconstitution. The patient's current medical condition included rheumatoid arthritis, bruised very badly and very easily and very sensitive. No co-suspect medications were reported. The patient began Enbrel with Single Dose Prefilled Syringe on an unknown date. The patient bruised very badly and very easily and stated he was very sensitive and that was the reason he had a nurse who gave him injections for the past 15 years. On an unknown date, at least 10 years ago or longer, the patient had noticed his left ear keep clogging up and it was still clogging up from time to time. He had to get his left ear perforated because of the clogging about 10 years ago. Over 10 years ago, the patient was switched from the Prefilled syringe to the Multi dose vial (MDV) due to the painful injections. The patient used to have to place an ice pack on the area of the injection site after each injection due to pain and stinging he felt from the injections. He only injected in his abdomen because injecting in his arms was not doing anything, and his doctor told him that the Enbrel absorbed better in his abdomen. On an unknown date in 2021, recently, the patient was seen at the ear, nose and throat doctor and the doctor told the patient the tube going from his ear was not working correctly. The doctor wanted to fill in the perforation but was hesitant because the doctor thought the clogging was from the Enbrel and it would just happen again. The patient had a very severe case of rheumatoid arthritis (RA). On an unknown date in 2021, the patient was recently switched from Multi dose vial (MDV) to the EMWAT due to the discontinuation of the Multi dose vial (MDV) and the patient stated he was going to use up the rest of his MDV medication before starting the new formulation which he planned to start using the EMWAT this week. No treatment information was received. The outcome of the event ear discomfort was reported as not recovered/not resolved. The outcome of the events lack of injection site rotation, injection site pain, complication associated with device was reported as unknown. Action taken with Enbrel was reported as unknown for the events lack of injection site rotation, ear discomfort, injection site pain, and complication associated with device. Action taken with Single Dose Prefilled Syringe was reported as unknown for the events ear discomfort. Action taken with Single Dose Prefilled Syringe was withdrawn for the event injection site pain. Action taken with Multiple Dose Vial Kit For Reconstitution was reported as unknown for the events lack of injection site rotation and complication associated with device. The causal relationship between the event ear discomfort and Enbrel was reported as related by the physician. The causal relationship between the events ear discomfort, lack of injection site rotation, injection site pain, complication associated with device and Enbrel, Single Dose Prefilled Syringe, Multiple Dose Vial Kit For Reconstitution was not provided by the consumer. It was reported that the patient experienced ear drainage, sinus infection, redness at injection site while receiving Enbrel, Reusable Autoinjector. On an unknown date in 2021, the patient switched to Enbrel mini. The patient developed redness at injection site. The patient had sinus infection and ear drainage. The patient was given an unspecified antibiotic therapy and missed doses. The outcome of the events otorrhea, sinusitis, injection site erythema was reported as not recovered/not resolved. Action taken with Enbrel and Reusable Autoinjector was temporarily withheld for the events sinusitis, otorrhea and injection site erythema. The causal relationship between the events sinusitis, otorrhea, injection site erythema and Enbrel was not provided by the consumer. The causal relationship between the events sinusitis, otorrhea, injection site erythema and Single Dose Prefilled Syringe, Multiple Dose Vial Kit For Reconstitution, Reusable Autoinjector was not provided by the consumer. The patient had blue marks on abdomen, infected rash on thigh that worsened with COVID-19 vaccine, itchy at injection site, sinus drainage, redness, acid reflux, thin skin, difficulty sleeping, shoulders worn out from rheumatoid arthritis, cough, tiredness ,depression, weakness in shoulder while receiving Enbrel, Single Dose Prefilled Syringe, Multiple Dose Vial Kit For Reconstitution, Reusable Autoinjector. The patient began Enbrel with Single Dose Prefilled Syringe on an unknown date in 2002. It was reported that, the patient had sinus drainage, cough, acid reflux, thin skin, depression, difficulty sleeping, tiredness, weakness in shoulders, redness and itchy at injection site, blue marks on abdomen, shoulder worn out from rheumatoid arthritis, infected rash on thigh that worsened with covid vaccine. It was also reported that, the patient had missed two doses of Enbrel because he got coronavirus disease of 2019 (COVID-19) booster and had to get off Enbrel for a little period. The patient also missed doses of Enbrel due to rash. Recently, the patient was started back on Enbrel. No treatment information was received. The outcome of the events ear discomfort, skin discoloration, dermatitis infected, injection site pruritus, sinusitis, injection site erythema, gastroesophageal reflux disease, skin atrophy, insomnia, arthritis, cough, fatigue, depression, asthenia was reported as not recovered/not resolved. Action taken with Enbrel was reported as unknown for the events gastroesophageal reflux disease, skin atrophy, insomnia, arthritis, cough, fatigue, injection site pruritus, skin discoloration, depression and asthenia. Action taken with Enbrel was temporarily withheld for the events sinusitis and dermatitis infected. Action taken with Single Dose Prefilled Syringe was reported as unknown for the events ear discomfort, gastroesophageal reflux disease, skin atrophy, insomnia, arthritis, cough, fatigue, injection site pruritus, skin discoloration, depression and asthenia. Action taken with Multiple Dose Vial Kit for Reconstitution was reported as unknown for the events gastroesophageal reflux disease, skin atrophy, insomnia, arthritis, cough, fatigue, injection site pruritus, skin discoloration, depression and asthenia. Action taken with Reusable Autoinjector was temporarily withheld for the events sinusitis, injection site erythema and dermatitis infected. Action taken with Reusable Autoinjector was reported as unknown for the events gastroesophageal reflux disease, skin atrophy, insomnia, arthritis, cough, fatigue, injection site pruritus, skin discoloration, depression and asthenia. The consumer reported that the events sinusitis, injection site erythema, gastroesophageal reflux disease, skin atrophy, insomnia, arthritis, dermatitis infected, cough, fatigue, injection site pruritus, skin discoloration, depression, asthenia was possibly related to Enbrel. The causal relationship between the events lack of sinusitis, injection site erythema, gastroesophageal reflux disease, skin atrophy, insomnia, arthritis, dermatitis infected, cough, fatigue, injection site pruritus, skin discoloration, depression, asthenia and Single Dose Prefilled Syringe, Multiple Dose Vial Kit for Reconstitution, Reusable Autoinjector was not provided by the consumer.  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.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.