Sex: F
Vaccine: COVID19, UNK
Symptoms: Hangover, Illness, Migraine, Nausea, Pain
Clinical narrative: more pain her her legs then before the Enbrel, especially by her right knee/thought she was having a flare; Terrible headache/Headache turned into a migraine; She got really sick; She has queasiness; Body ache; Hangover feeling; hands are also so swollen, she feels like she can see the fluid between the joints; patchy light rash on both feet that is new this week; This is a solicited report from Pfizer (marketing program name not available) from a contactable consumer, based on information received by Pfizer license party for etanercept (ENBREL).  This non-serious solicited report was reported to Amgen on 15/APR/2021 by a consumer from a commercial program and involves a 41 year old female patient who experienced terrible headache/headache turned into a migraine [PT: migraine], she got really sick [PT: illness], she has queasiness [PT: nausea], body ache [PT: pain], hangover feeling [PT: hangover] 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 an unknown date, the patient received the Covid vaccination while on Enbrel and did well with the first one but the second one she got really sick. The patient had queasiness, body ache and terrible headache for about one and one half days. The patient stated that the headache turned into a migraine which led into a another day of not feeling well with that post migraine hangover feeling. The patient was doing much better now. No treatment information was received. The outcome of the events migraine, illness, hangover were reported as recovering/resolving. The outcome of the events nausea, pain were reported as recovered/resolved. The events nausea, pain were resolved on an unknown date. Action taken with Enbrel and Reusable Autoinjector was reported as unknown for the events migraine, illness, nausea, pain and hangover. The causal relationship between the events migraine, illness, nausea, pain, hangover and Enbrel, Reusable Autoinjector was not provided by the consumer. The patient declined to provide lot number. The reporter declined consent for follow up.   Causality Assessment: Hangover, General body pain, Nausea, Sickness, Migraine Per Company (Amgen) = No.  The reporter's assessment of the causal relationship of the events with the suspect product 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.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.  Follow-up (22Apr2021): This is a follow-up solicited report from a Pfizer from a contactable consumer, based on information received by Pfizer license party for etanercept (ENBREL).  ADDITIONAL INFORMATION RECEIVED ON 22/APR/2021: This case was upgraded to serious. In this follow up, the patient stated. more pain her legs than before the Enbrel, especially by her right knee/thought she was having a flare [PT: rheumatoid arthritis], hands are also so swollen, she feels like she can see the fluid between the joints [PT: peripheral swelling], patchy light rash on both feet that is new this week [PT: rash] while receiving Enbrel with Reusable Autoinjector. On an unknown date, the patient stated that she was having more pain her legs than before the Enbrel, especially by her right knee. The patient called the doctor to see if they wanted to see her but thought she was having a flare and Enbrel had not kicked in after only four doses. They gave her a steroid pack prescription. The patient stated that her hands were also so swollen, she felt like she could see the fluid between the joints. On an unknown date in APR/2021, she stated she also had a diffuse patchy light rash on both feet and was not itchy or sore, will let doctor know.The outcome of the event rheumatoid arthritis was reported as not recovered/not resolved. The outcome of the events peripheral swelling, rash were reported as unknown. Action taken of Enbrel with Reusable Autoinjector was reported as unknown for the events rheumatoid arthritis, peripheral swelling and rash. The causal relationship between the events arthralgia, rheumatoid arthritis, peripheral swelling, rash and Enbrel with Reusable Autoinjector was not provided by the consumer. The reporter did not and would never have access to lot number. The reporter declined consent to contact. No follow up attempts are possible. No further information is expected.  Amgen Comment:This individual case report does not change the safety profile of the product.  Causality Assessments: Rash, Per Company(Amgen)=Yes Hand swelling, Rheumatoid arthritis flare up, Hangover, General body pain, Nausea, Sickness, Migraine. Per Company(Amgen)= No; Sender's Comments: Based on an implied event-vaccine chronological association the reported events were possibly related to BNT162B2 vaccine; the events were not related to etanercept. The events Rheumatoid arthritis flare, peripheral swelling and rash are attributed to underlying or intercurrent medical conditions and assessed Unrelated to suspect products BNT162B2 vaccine or etanercept.