Age: 62.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Drug ineffective, Off label use, Psoriatic arthropathy
Clinical narrative: psoriatic arthritis flare up with significant joint pain/ joint pain and swelling in hands which was new/continuing the Enbrel every 7 days to see if helped which it did not; psoriatic arthritis flare up with significant joint pain/ joint pain and swelling in hands which was new/continuing the Enbrel every 7 days to see if helped which it did not; injecting about every 10 days; This is a spontaneous report from a contactable consumer (patient). A 48-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration in Dec2020 at dose 1, single for covid-19 immunization and dose 2 via an unspecified route of administration in Dec2020 (Batch/Lot number was not reported) at dose 2, single for covid-19 immunization and received etanercept (ENBREL, Powder for solution for injection), via an unspecified route of administration from 2005 to an unspecified date and 2006 (Batch/Lot number was not reported) to Jan2021, dose unspecified at every 10 days, via an unspecified route of administration from 13Jan2021 (Batch/Lot number was not reported) to an unspecified date in 2021, dose unspecified weekly (at every 7 days) for psoriatic arthritis. The patient medical history and concomitant medications were not reported. After receiving the Pfizer covid vaccines, the patient had experienced a psoriatic arthritis flare up with significant joint pain which she has never had while taking Enbrel the past 15 years. and the Enbrel was no longer working. The Enbrel stopped working in Jan2021. Patient had been injecting about every 10 days and with great psoriasis and arthritis control up until the early Jan2021. Patient had an appointment with dermatologist for a regular visit on 13Jan2021 and reported to him she had noticed joint pain and swelling in hands which was new. He suggested continuing the Enbrel every 7 days to see if helped which it did not, patient was taking Tylenol and Ibuprofen as well with little improvement. The joint pain and discomfort have continued to get worse; we have now switched to SKYRIZI with little improvement, also have done 2 rounds of Medrol Dose pack with great relief but the pain returns when off the steroids. Am now trying maintenance dose of prednisone which we are still tweaking. wanted to report as unsure if vaccine played a part of this flare. The action taken in response to the events for etanercept was permanently withdrawn on an unspecified date in 2021 and bnt162b2 was not applicable. The outcome of the events 'psoriatic arthritis flare up with significant joint pain/ joint pain and swelling in hands which was new/continuing the Enbrel every 7 days to see if helped which it did not' was recovering whereas for other events it was unknown.   No follow-up attempts are needed. Information about lot/batch number cannot be obtained.  Follow-up (07Jul2021): This follow-up is being submitted to notify that the batch and lot number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.  Follow-up (13Jul2021): This is a follow-up spontaneous report from a non-contactable Physician. This Physician reported in response to HCP follow-up letter sent that included: New reporter, new suspect product (bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) with doses, start and stop date, new dose regimen (start date 2005) for ENBREL and concomitant drug was removed (updated as suspect drug).  This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.