Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Skin mass, Swelling, Ultrasound scan
Clinical narrative: right leg is swollen and red; right leg is swollen and red; pain in her right lower leg; diagnosed yesterday with erythema nodosum which is considered both an autoimmune disorder and an inflammatory disease; pain; swelling; hard mass in her right lower leg; diagnosed yesterday with erythema nodosum which is considered both an autoimmune disorder and an inflammatory disease; diagnosed yesterday with erythema nodosum which is considered both an autoimmune disorder and an inflammatory disease; Increased blood pressure; This is a spontaneous report from a contactable nurse (patient). A 64-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 11Mar2021 at around 09:20 (Lot Number: EN6204) at the age of 64-year-old, as dose 2, single for covid-19 immunisation. The patient medical history was none. Historical Vaccine included first dose of bnt162b2 via an unspecified route of administration, administered in left arm on 19Feb2021 at around 9:30 (Lot Number: EN6201, Expiry: 30Jun2021) at the age of 64-year-old, as dose 2, single for covid-19 immunisation. The patient's concomitant medications were not reported. The reporter is a nurse practitioner and is calling about symptoms she is experiencing after receiving both doses of the Pfizer covid 19 vaccine. She received her first dose on 19Feb2021 and her second dose 11Mar2021. At the end of April, she experienced pain, swelling, hard mass in her right lower leg. She was diagnosed yesterday with erythema nodosum which is considered both an autoimmune disorder and an inflammatory disease. She is aware that some vaccines can cause autoimmune disorders. She wanted to know if people are filing reports on this so others can find out what odd things are being caused by the vaccine. She expressed frustration as a practitioner not being able to more  easily find information. She has heard of people who already had covid getting this condition, wanted to know if its from the vaccine. As a nurse, she has been tested every two weeks and never had a positive test. She said when her symptoms first started, if she had known, it would have been easier to receive a diagnosis. She got the vaccine and right after had an increase in her blood pressure but it went back to normal. She was just diagnosed yesterday with Erythema Nodosum. She states that this is an autoimmune disorder that people who have had Covid may get; because of where she works, she has been tested for Covid every 2 weeks and she has never had Covid but has received both doses of the vaccine. It was reported the Increased blood pressure was from Mar2021 to Apr2021; the Erythema nodosum was Apr2021 and ongoing. Reporter seriousness for Increased blood pressure and Erythema nodosum was not serious. Erythema nodosum was reported as worsened. Information about erythema nodosum: patient stated that this was costing her a fortune because she can't work and has had to pay for all these tests and medications; the doctors have been treating her with a number of different medications because they didn't have a diagnosis until yesterday. This has been ruining her life. It all started the end of Apr2021, she was having pain in her right lower leg. Then it felt hard like a rock, like a mass was in there; it was just so painful. In May2021 she had an ultrasound looking for a blood clot in her leg but it was negative. Then she had a MRI on 10Jun2021 looking for a mass in her leg, but that was also negative. She was on clindamycin in between the ultrasound and the MRI. Then after the MRI, she was put on prednisone, but it didn't help so she was put on Keflex, then she was put on ketoconazole. She finally saw a Dermatologist yesterday and got a diagnosis and he put her back on the prednisone for 1 month. She has also used heat/cold/support hose to try to help with the pain and swelling. States that her right leg is swollen and red, and she is worried that she may lose her leg. It's been getting worse over the last 3 weeks; it's painful, enlarged and hard. She does not have the Lot/NDC/Expiry for the clindamycin, prednisone, keflex, and ketoconazole that she took prior to diagnosis. The patient underwent lab tests and procedures which included magnetic resonance imaging (MRI) right leg: no mass found on 10Jun2021; Ultrasound right leg: no blood clot on May2021. The outcome of erythema nodosum was not recovered; of increased blood pressure was recovered on the end of Apr2021; of other events was unknown.  Follow-up attempts are needed. Further information is expected.; Sender's Comments: Based on the current limited available information and the drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of event of erythema nodosum which is considered both an autoimmune disorder and an inflammatory disease cannot be totally excluded/assessed.  The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.