Sex: F
Vaccine: COVID19
Symptoms: Fear, Impaired healing, Pain, Skin mass
Clinical narrative: lumps were inflamed and very painful/some of the lumps protruded through her skin and they wouldn't heal/inflamed lumps on her legs; lumps were inflamed and very painful/lumps press on the nerve endings and cause pain; having trouble with that wound because it won't heal properly; afraid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 64 year-old female patient received bnt162b2 (BNT162B2), administered in arm, administration date Aug2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Calciphylaxis" (ongoing), notes: It has been at least 4 or 5 years that the patient has struggled with it; "End stage renal disease" (ongoing), notes: has it for least 7 to 8 years; "dialysis" (ongoing); "COPD" (ongoing), notes: has it for quite a long time; "A Fib", start date: 2020 (ongoing), notes: diagnosed recently/within last year; "Congestive heart failure" (ongoing), notes: diagnosed within the last 2 to 3 years; "lymphedema in her legs" (ongoing), notes: for at least 2 years; "blood pressure" (unspecified if ongoing), notes: taking blood pressure medications but then her blood pressure started dropping too low so they took her off of that; "painful lumps" (unspecified if ongoing). The patient took concomitant medications. Vaccination history included: Covid-19 vaccine (dose 1, unknown manufacturer), for COVID-19 immunization; Flu shot, for immunization. The following information was reported: SKIN MASS (hospitalization) with onset Aug2021, outcome "recovered" (Sep2021), described as "lumps were inflamed and very painful/some of the lumps protruded through her skin and they wouldn't heal/inflamed lumps on her legs"; PAIN (hospitalization) with onset Aug2021, outcome "recovered" (Sep2021), described as "lumps were inflamed and very painful/lumps press on the nerve endings and cause pain"; IMPAIRED HEALING (non-serious) with onset 2021, outcome "not recovered", described as "having trouble with that wound because it won't heal properly"; FEAR (non-serious) with onset 2021, outcome "unknown", described as "afraid". The patient was hospitalized for skin mass, pain (start date: Sep2021, discharge date: Sep2021). The events "lumps were inflamed and very painful/some of the lumps protruded through her skin and they wouldn't heal/inflamed lumps on her legs" and "lumps were inflamed and very painful/lumps press on the nerve endings and cause pain" were evaluated at the physician office visit. Therapeutic measures were taken as a result of skin mass, pain. Clinical course: The reporter called on behalf of her 64-year-old sister, who received the second dose of either the Pfizer COVID-19 vaccine or the Moderna COVID-19 vaccine (reporter was unsure which vaccine the patient received so she emailed both companies and Pfizer was the first one that responded). It was probably somewhere around the 1st or 2nd week in Aug2021 for when the patient had the vaccine. The reporter confirmed that the patient has calciphylaxis where her body does not process calcium and end stage renal disease. The reporter further described the condition as the patient's kidneys do not process calcium in her body, any calcium that is in her body has to be collected in the capillaries in the fatty layer of her skin and it forms lumps. The lumps are very painful. It was a very serious disease that causes calcium to form in her lungs and in the body. The reporter would like to know if the Pfizer COVID-19 vaccine had any form of calcium in it. The patient felt that after she received the 2nd vaccination shot, all the lumps were inflamed and very painful. The lumps press on the nerve endings and cause pain. She doesn't really know if it was connected at all, but after the injection, some of the lumps protruded through her skin and they wouldn't heal. The events did not result in emergency room visit, but the patient went to the physician's office to have it looked because it was not healing. They finally decided to do surgery and remove the lumps.  The patient had surgery to remove the inflamed lumps on her legs at the end of Sep2021 and she had the open wounds on her legs for at least 6 weeks. The patient was hospitalized after the surgery for probably two or three days because they didn't want to keep for long out of fear of her getting COVID, so she had to go home and now she is still having trouble with that wound because it won't heal properly, and it has been three months. From what the reporter understands, the side effects began within a few days of having the 2nd dose, she thinks. That's why the patient had connected them with the 2nd vaccination. The patient has a lot of health problems due to the end stage renal disease, but the reporter doesn't know if that has any bearing on what the patient has experienced.  With regards to patient's medical history, patient takes inhaler for her COPD. For the lymphedema in her legs, she has to wear those heavy leg wraps to keep the swelling down. The patient was also taking blood pressure medications but then her blood pressure started dropping too low, so they took her off of that. Other than all of that, the patient is just fine. The patient is trying so hard to get her spirits up, but it is getting more and more difficult. Now, the patent is afraid to get the booster shot because of this and because she doesn't want more of these things to get inflamed and to have further surgery. No additional vaccines administered on same date of the Pfizer suspect. No prior vaccinations (within 4 weeks).  The lot number for bnt162b2 was not provided and will be requested during follow up.