Sex: F
Vaccine: COVID19
Symptoms: Arrhythmia, Arthralgia, Dizziness, Dyspnoea, Hepatic enzyme
Clinical narrative: flare; her injection site reactions which use to be 6 inches and itchy are down to 3 inches and much less itch; injection site reactions/started out as size of a quarter/now 6 inches on stomach/last week did it on leg, it was less in size but still raised, red, angry but not as painful as stomach one/down to 3; injection site reactions/started out as size of a quarter/now 6 inches on stomach/last week did it on leg, it was less in size but still raised, red, angry but not as painful as stomach one/down to 3; injection site reactions/started out as size of a quarter/now 6 inches on stomach/last week did it on leg, it was less in size but still raised, red, angry but not as painful as stomach one/down to 3; increase in joint pain; increase in swelling in her hands and toes; liver enzyme increased; allergic reaction; dizzy; could not breathe/shortness of breath; hot flash; arrhythmia; 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(manufacturer control number: US-AMGEN-USASL2021055143), license party for etanercept (ENBREL).  This solicited report (USASL2021055143) was reported on 08Apr2021 by a consumer from a commercial program (PSP00086) and involves a 39 years old female patient who experienced injection site reactions/started out as size of a quarter/now 6 inches on stomach/last week did it on leg, it was less in size but still raised, red, angry but not as painful as stomach one (PT: injection site swelling, PT: injection site erythema, PT: injection site pain), increase in joint pain (PT: arthralgia), increase in swelling in her hands and toes (PT: peripheral swelling) while receiving Enbrel, Single Dose Prefilled Autoinjector. The patient's historical medical condition included shoulder surgery. 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 an unknown date in Jan2021. On an unknown date in Jan2021, the patient reported that she had been doing Enbrel since January and just this month after her surgery. On an unknown date 2021, it was reported that surgery went well, took 10 days off of Enbrel and could feel an increase in joint pain and swelling in her hands and toes. After ten days, in 2021, the patient back on Enbrel, so she knows the Enbrel was helping her RA. Additionally, the patient developed injection site reactions. She said they started out as the size of a quarter but are now up to 6 inches 2 weeks ago on her stomach. On an unknown date in 2021, last week, she did it on her leg and used topical Hydrocortisone cream which helped. Additionally, it was less in size but was still raised, red and angry but not as painful as her stomach one. Her doctor recommend Benadryl cream (diphenhydramine hydrochloride), icing and to take an oral Benadryl (diphenhydramine hydrochloride), 30 minutes before the injection to minimize the reaction. The outcome of the events injection site swelling, injection site erythema was reported as not recovered/not resolved. The outcome of the events injection site pain, arthralgia, peripheral swelling were reported as unknown. Action taken with Enbrel, Single Dose Prefilled Autoinjector was reported as unknown for the events injection site swelling, injection site erythema and injection site pain. The causal relationship between the events injection site swelling, injection site erythema, injection site pain, arthralgia, peripheral swelling and Enbrel, Single Dose Prefilled Autoinjector was not provided by the consumer. The reporter declined consent to contact. No follow up attempts are possible. No further information is expected. Causality Assessment for the events Peripheral swelling, Arthralgia, Injection site pain, Injection site erythema, Injection site swelling: 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 (29Jun2021): 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 (manufacturer control number: US-AMGEN-USASL2021055143), license party for etanercept (ENBREL).  ADDITIONAL INFORMATION RECEIVED ON 29/JUN/2021: This case was upgraded to serious. In this follow-up, it was reported that the patient had flare [PT: rheumatoid arthritis], liver enzyme increased [PT: hepatic enzyme increased], injection site reactions which use to be six inches and itchy are down to three inches and much less itchy [PT: injection site pruritus], down to three inches and much less itchy [PT: injection site swelling, injection site erythema and injection site pain] while receiving Enbrel, Single Dose Prefilled Autoinjector. The patient's co-suspect medication included covid-19 vaccine. On an unknown date in early APR/2021, the patient gad the first dose of covid-19 vaccination. Subsequently, the patient had an allergic reaction. The patient felt dizzy, could not breathe, shortness of breath, hot flash and arrhythmia. On an unknown date in 2021, the patient was straightened out in the ER (Emergency room) and was placed on unspecified steroids and inhalers. The patient recovered all right. On an unknown date in 2021, the patient had flare. Subsequently, the patient was placed on methotrexate. On an unknown date in 2021, the patient was doing better and injection site reactions which used to be six inches and itchy are down to three inches. They are much less itchy. The patient stated that her energy was up and her pain if down. The patient contributes that to Enbrel. On an unknown date in 2021, the patient had some laboratory test with an increase in her liver enzymes. On an unknown date in 2021, the dose of methotrexate was increased with the flare-up. At the time of this report, the patient is still scheduled to ween off some steroids. The patient thought that her physician would decrease the dose in two days (01/JUL/2021) on her physician visit. The outcome of the event rheumatoid arthritis was reported as not recovered/not resolved. The outcome of the events injection site pruritus, injection site swelling, injection site erythema, injection site pain were reported as recovering/resolving. The outcome of the event hepatic enzyme increased was reported as unknown. Action taken with Enbrel with Single Dose Prefilled Autoinjector was reported as unknown for the events rheumatoid arthritis, injection site pruritus and hepatic enzyme increased. The causal relationship between the events rheumatoid arthritis, injection site pruritus, hepatic enzyme increased and Enbrel with Single Dose Prefilled Autoinjector was not provided by the consumer. The reporter did not and would never have access to lot number. The reporter declined consent for follow up. No follow up attempts are possible. No further information is expected.  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 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.        Causality Assessment: The event injection site itching was assessed as related to etanercept. The events injection site swelling, injection site redness, injection site pain, joint pain, peripheral swelling, rheumatoid arthritis flare up and hepatic enzyme increased were assessed as unrelated to etanercept.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Based on temporal association, the events hypersensitivity, dizziness, dyspnea, hot flush, and arrhythmia are assessed as related to BNT162B2 and are unrelated to Etanercept and Methotrexate. The events injection site pruritus, injection swelling, injection site pain, and injection site redness are assessed as related to Etanercept and unrelated to BNT162B2 vaccine and Methotrexate, Based on known safety profile and temporal association, the event hepatic enzyme increased is assessed as possibly related to Methotrexate and unrelated to BNT162B2 and Etanercept. The other events are assessed as unrelated to suspect products based on the available information, but likely related to the underlying disease.