Sex: F
Vaccine: COVID19
Symptoms: Antibody test, Blood albumin, Blood creatinine, COVID-19, Investigation
Clinical narrative: she suffered a COVID-19 infection; she suffered a COVID-19 infection; Full-Blown Nephrotic Syndrome/Following COVID-19 Infection; This is a literature report for the following literature source(s):  A 66-year-old female patient received BNT162b2 (BNT162B2), in Apr2021 as dose 1, single (Batch/Lot number: unknown), in Apr2021 as dose 2, single (Batch/Lot number: unknown) and in Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "type 2 DM" (ongoing), notes: 6 year history of well-controlled DM. The patient's concomitant medications were not reported. The following information was reported: COVID-19 (medically significant) with onset Jan2022, outcome "unknown", VACCINATION FAILURE (medically significant), outcome "unknown" and all described as "she suffered a COVID-19 infection"; NEPHROTIC SYNDROME (medically significant) with onset 2022, outcome "unknown", described as "Full-Blown Nephrotic Syndrome/Following COVID-19 Infection". The patient underwent the following laboratory tests and procedures: Antibody test: (unspecified date) Negative; Blood albumin: (unspecified date) 2.2 g/dl; Blood creatinine: (unspecified date) 0.92 mg/dl; evaluation: (unspecified date) she had pitting edema to the abdomen and sacral, notes: edema; Light chain analysis: (unspecified date) Negative; Serology test: (unspecified date) serum free light chains and anti-PLA2R antibody, notes: was negative; Urine albumin/creatinine ratio: (May2021) less than 30; (Apr2022) greater than 22000, notes: increased.  Clinical Course: Patient with 6 year history of well-controlled type 2 DM but no history of retinopathy, proteinuria, or kidney disease received the Pfizer-BioNTech vaccine x 2 in April2021 and Pfizer booster in October 2021. She had an exuberant local reaction each time she had a vaccine. In January 2022, she suffered a COVID-19 infection and about 6 weeks later, she noted the onset of peri-orbital edema followed by progressive leg edema. At the time of evaluation 5 weeks later, she had pitting edema to the abdomen and sacral edema. Overall, she gained 30 pounds of edema. She had not used any new medications including NSAIDs.A kidney biopsy was scheduled and the results are pending. Patient had a severe local reaction to the 2 vaccines she received in April 2021, she did not have proteinuria in May 2021 and did not present with nephrotic syndrome until 6 weeks after a COVID-19 infection in January 2022.she will have MCD triggered by immune dysfunction, dysregulation, or a circulating permeability factor affecting the podocytes. Of course, it is also possible that the development of her nephrotic syndrome was not related to her COVID vaccinations or infection.; Sender's Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal relationship between the events vaccination failure, covid-19, nephrotic syndrome and suspect drug BNT162B2 cannot be excluded. 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.,Linked Report(s) : US-PFIZER INC-202201393870 Same article/patient/drug and different event.;