Age: 27.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Product administered at inappropriate site, Rheumatoid arthritis
Clinical narrative: she gave it down towards her knee on her leg; injection was very painful/some burning during the injection; injected the area swelled up as she gave it and became red; injected the area swelled up as she gave it and became red; had a flare for the past couple of days/pretty bad flare/ put her into a flare/ Feeling really bad; 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 , license party for etanercept (ENBREL). This non-serious solicited report was reported to Amgen on 05Apr2021 by a consumer from a commercial program and involves a 27 year old female patient who gave it down towards her knee on her leg (PT: product administered at inappropriate site), injection was very painful (PT: injection site pain), injected the area swelled up as she gave it and became red (PT: injection site swelling and PT: injection site erythema) while receiving Enbrel with Single Dose Prefilled Autoinjector. 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 with Single Dose Prefilled Autoinjector on 04Apr2021. On 04Apr2021 last night, the patient took her first injection of Enbrel last night and when she injected the area swelled up as she gave it and became red. The patient reported injection was very painful and she recounted that she gave it down towards her knee on her leg. On 05Apr2021 same day of this report, the patient reported it was sore but no longer red. The patient was referred to HCP and arranged for an in home patient training for next injection. No treatment information was received. The outcome of the event injection site pain was reported as not recovered/not resolved. The outcome of the event injection site erythema was reported as recovered/resolved. The outcome of the events product administered at inappropriate site, injection site swelling were reported as unknown. The event injection site erythema was resolved on 05Apr2021. Action taken with Enbrel and Single Dose Prefilled Autoinjector was reported as unknown for the events injection site pain, injection site swelling and injection site erythema. The causal relationship between the events injection site pain, injection site swelling, injection site erythema, product administered at inappropriate site and Enbrel, Single Dose Prefilled Autoinjector was not provided by the consumer. The reporter declined consent for follow up. No follow-up attempts are possible. No further information is expected. Causality Assessment for the events Pain during injection, Injection site redness, Injection site swelling, per Company (Amgen): related. Causality Assessment for the event Product administered at inappropriate site, per Company (Amgen): Not related.  The reporter's assessment of the causal relationship of the events 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.  Follow-up (12Apr2021): This is a follow-up 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, license party for etanercept (ENBREL).  ADDITIONAL INFORMATION RECEIVED ON 12/APR/2021 AND 20/APR/2021: This case was upgraded to serious case. In this follow up, it was reported that the patient had a flare for the past couple of days/pretty bad flare [PT: rheumatoid arthritis], some burning during the injection [PT: injection site pain] while receiving Enbrel, Single Dose Prefilled Autoinjector. It was previously reported that the patient first injected close to her knee and had a bad injection experience with immediate pain and swelling at the site. On unknown date in APR/2021, the patient stated that for the past couple of days she had a flare especially in her hands. On 12/APR/2021, the patient stated that she did her injection higher on the thigh to ensure a subcutaneous injection and she had no swelling or pain. On 16/APR/2021 (Friday of last week), the patient had a pretty bad flare that subsided on the weekend prior to her last injection. On 19/APR/2021, the patient injected in her thigh and she had some burning during the injection that lasted for about a minute afterwards. The outcome of the events rheumatoid arthritis and injection site pain were reported as recovered/resolved. The event injection site pain was resolved on 19/APR/2021. The event rheumatoid arthritis was resolved on an unknown date in APR/2021. Action taken with Enbrel and Single Dose Prefilled Autoinjector was continued for the event rheumatoid arthritis. The causal relationship between the event rheumatoid arthritis, Enbrel and Single Dose Prefilled Autoinjector was not provided by the consumer. 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 the events 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.  Amgen Comment: This individual report does not change the safety profile of the product.    Amgen Causality Assessment: Rheumatoid arthritis flare up, Product administered at inappropriate site assesses as unrelated while Injection site redness, Injection site swelling, Pain during injection assessed as related to etanercept.  Follow-up (26Apr2021): The following clarification was received from Amgen to clarify the route of administration of Enbrel, included: The event reported was Product administered at inappropriate site "gave it down towards her knee on her leg [PT: product administered at inappropriate site" & "when she injected the area swelled up as she gave it and became red." Following the initial dose that was administered inappropriately, "On 12/APR/2021, the patient stated that she did her injection higher on the thigh to ensure a subcutaneous injection and she had no swelling or pain" The reporter declined consent for follow up. No follow-up attempts are possible. No further information is expected.  Follow-up (27Apr2021): This is a follow-up 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, license party for etanercept (ENBREL).   ADDITIONAL INFORMATION RECEIVED ON 27/APR/2021: The outcome of the previously reported event rheumatoid arthritis was updated to recovering/resolving. Action taken with Enbrel, Single Dose Prefilled Autoinjector for the previously reported event rheumatoid arthritis was updated to not applicable. In this follow up it was reported that the patient experienced a flare/ feeling really bad [PT: rheumatoid arthritis] while receiving Enbrel, Single Dose Prefilled Autoinjector. The patient's co-suspect medication included COVID-19 (corona virus disease-2019) vaccine. On 25/APR/2021, Sunday, the patient received her second dose of COVID (corona virus disease) vaccine. So, the patient skipped a dose of Enbrel therapy. Then on 26/APR/2021, yesterday of this report, the patient felt really bad. She thought the vaccine put her into a flare. She was doing a little better today. She would restart Enbrel later today and switched her injection day to Tuesday. She also mentioned that this time, she didn't have a flare at the end of the week, as she had with her prior dose. So, she thought that without the COVID vaccine, she would had been fine. The outcome of the event rheumatoid arthritis was reported as recovering/resolving. No follow-up attempts are possible. No further information is expected.  Amgen comment: This individual 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 etanercept and BNT162B2 (reported as "COVID vaccine") 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.  Amgen's Causality Assessment: The events Pain during injection, Injection site redness, Injection site swelling were related to etanercept. The events Rheumatoid arthritis flare up, Product administered at inappropriate site were unrelated to etanercept.; Sender's Comments: The reported events of injection site pain, injection site swelling and injection site erythema were assessed as possibly related to etanercept based on temporal association and known drug safety profile. Reported event rheumatoid arthritis flare is an intercurrent medical conditions and is unlikely related to Enbrel.  Pfizer comment: Confirmed the Amgen assessment for Enbrel. The reported events were assessed as not related to BNT162B2. The events preceded, most of them already recovered, at the time of vaccine injection.