Sex: F
Vaccine: COVID19
Symptoms: Biopsy, Imaging procedure, Laboratory test, Respiratory disorder, Transplant rejection
Clinical narrative: AMR; severe respiratory compromise; This is a literature report from a contactable healthcare professional for the following literature source: "COVID-19 Vaccine Triggered Rejection in Lung Transplant Recipients: A Case Series", Journal of Heart and Lung Transplantation, 2022; Vol:41 (4 Suppl); pgs:S533, DOI: 10.1016/j.healun.2022.01.1352.  A female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), (Batch/Lot number: unknown) as dose 2, single for COVID-19 immunisation. The patient's relevant medical history included: "Lung transplant". The patient's concomitant medications were not reported. Vaccination history included: COVID-19 vaccine (Dose 1, Manufacturer unknown), for COVID-19 immunisation.  The following information was reported: ANTIBODY-MEDIATED REJECTION (medically significant, hospitalization), outcome "unknown", described as "AMR"; RESPIRATORY DISORDER (hospitalization), outcome "unknown", described as "severe respiratory compromise". The events "AMR", "severe respiratory compromise" required physician office visit.  Clinical course: In this series, 3 patients developed new and significant respiratory compromise after their second vaccine dose consistent with antibody mediated rejection (AMR). Three fully vaccinated patients with approved mRNA vaccines (2 Moderna, 1 Pfizer-BioNTech) were identified after developing severe respiratory compromise post 2nd vaccine dose. Evaluation revealed AMR as the underlying etiology. Results: All patients were female, ages 50-70 years old, between 6 months and 2 years post-transplant. No previous rejection episodes. All were on standard IS as per institution protocols. Two were hospitalized with hypoxic respiratory failure within 2 weeks of their 2nd vaccine dose. The 3rd was seen at clinic for milder similar symptoms, later progressing and requiring supplemental oxygen (O2) and hospitalization. Imaging showed new lung infiltrates, infectious work up was negative. Biopsies did not show any cellular rejection. All developed new DSAs and received treatment for AMR with plasmapheresis, IVIg, and Rituximab. Two recovered their lung function and are off supplemental O2, the 3rd did not and is relisted for transplant. Conclusion: While LTR have a diminished response to SARS-CoV-2 vaccines making them more vulnerable to the disease, their immune system's response may not always be clear. The authors report three cases of patients developing severe AMR from new DSAs that appear to be triggered by the COVID-19 vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the currently available information the possibility of causal association between the events reported and the suspect drug BNT162B2  cannot be ruled out. The case will be reassessed once new information is 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