Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: C-reactive protein increased, Glomerular filtration rate decreased, Inflammation, Injury, Positron emission tomogram
Clinical narrative: swelling along the scar where she had her left breast; leaking and little cuts all along where her radiation therapy was/ tiny cuts on the area of the scar of her left breast; leaking/ discharge along the breast scar/fluid in the breast that she had surgery/seepage from the scar on her left breast; The breast also looks distorted; her inflammation markers including CRP were elevated and her creatinine kinase was elevated and her GFR dropped by 35; her inflammation markers including CRP were elevated and her creatinine kinase was elevated and her GFR dropped by 35; her inflammation markers including CRP were elevated and her creatinine kinase was elevated and her GFR dropped by 35; her inflammation markers including CRP were elevated and her creatinine kinase was elevated and her GFR dropped by 35; This is a spontaneous report from a contactable consumer (patient herself). A 76-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Lot number Expiry date was not reported), via an unspecified route of administration on Feb2021 (at the age of 76-years-old) as dose 2, single for covid-19 immunisation. Medical history included breast cancer (25 years ago and then a recurrence in 2015 and unknown if ongoing), radiation therapy and scar. She also had surgery in May2015 for the recurrence and unknown if ongoing. Patient received the first dose of the Pfizer BioNTech Covid 19 vaccine at the end January and her second dose at the end of February. She stayed after the dose for 40 minutes and had no immediate side effects. She takes no medication, and never takes vaccines because she was so sensitive except for this one. After the second dose of the vaccine, she developed swelling along the scar where she had her left breast. She also developed leaking and little cuts all along where her radiation therapy was. She no longer has a nipple, so the leaking was not from that. The breast also looks distorted from an unknown date and unknown if ongoing. There were no concomitant medications. The patient concomitant medications were not reported. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number Expiry date was not reported), via an unspecified route of administration on Jan2021 as dose 1, single for covid-19 immunisation. On 09Apr2021 she saw her doctor for the leaking/discharge along the breast scar and they noted there was no surrounding redness and then she was referred to a radiation oncologist. On 28Apr2021 the radiation oncologist sent her to see a lymphedema specialist for a PET scan. She had the PET scan on 21May2021. She also had bloodwork done on 28June2021. On 08Jul2021 she had a zoom appointment to review the results of her bloodwork and PET scan. She was told her inflammation markers including CRP were elevated and her Creatinine Kinase was elevated and her GFR dropped by 35. She says she has no signs of inflammation other than the breast area. The doctor said they did not know what was wrong but that she has inflammation all over. The doctor told her bloodwork was trending in the wrong direction, and that if it did not improve, she might have to start blood pressure medication. She says she takes no medicine because she was very sensitive. She was getting all her bloodwork rechecked in September. She wants to know if there was any information about the Pfizer BioNTech Covid 19 vaccine and radiation recall (where an area that has previously had radiation therapy becomes inflamed again) and had inflammation even if they were asymptomatic for the disease. She was concerned she may have myocarditis due to her bloodwork. Stated that she normally does not do vaccines but did this one the end of January with second towards end of February. Stated that they watched her for 40 minutes separately that went really well. Patient stated that she was due to have a mammogram and had breast cancer. Stated that they told her that she had to wait 6 weeks after the vaccine due to false positives and at the end of June she had an appointment with radiation oncologist because all the way back 15 years ago that she had breast cancer also. She went to the clinic and experienced fluid in the breast that she had surgery. Stated that she surgery had in May2015 had a scar and they had removed nipple and all of that. Clarified that it was the left breast and they sent her for a PET scan which she did and she made an appointment with her radiation oncologist before she left because she had therapy for swelling and her left breast was distorted. She had surgery previously on her left breast for breast cancer and saw tiny cuts on the area of the scar of her left breast. There was seepage from the scar on her left breast and the radiation oncologist had heard about radiation recoil and her left breast surgery was before vaccine in 2015. Wanted to know what events recorded because they were affecting her in multiple areas because she was very sensitive. Stated that she needed information before goes back to repeat certain tests and she went online things were known now that were not in January and February. She needed to know number of cases and how to proceed in multiple areas and all of a sudden, her blood labs trending in wrong direction showing inflammation in multiple areas where there should not have been any. No further details provided. She did not recognize a reaction until she came back and spoke with doctor. Unable to determine if this was after the first or second dose. The patient underwent lab tests and procedures which included blood test: inflammation markers including CRP were elevated on 28Jun2021 inflammation markers including CRP were elevated and her Creatinine Kinase was elevated and her GFR dropped by 35, positron emission tomogram: inflammation markers including CRP were elevated on 21May2021 inflammation markers including CRP were elevated and her Creatinine Kinase was elevated and her GFR dropped by 35. The patient receive treatment for the adverse event. The outcome of the events was unknown.  The batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.