Received Jan 20, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA)) | MODERNA | 1 | — | — |
Antibody-mediated rejection/ vaccine induced rejection in Lung transplant recipient (LTR); This literature-non-study case was reported in a literature article and describes the occurrence of TRANSPLANT REJECTION (Antibody-mediated rejection/ vaccine induced rejection in Lung transplant recipient (LTR)) in a female patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis. LITERATURE REFERENCE: The patient's past medical history included Lung transplant. On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced TRANSPLANT REJECTION (Antibody-mediated rejection/ vaccine induced rejection in Lung transplant recipient (LTR)) (seriousness criteria hospitalization and medically significant). The patient was treated with Rituximab for Antibody-mediated rejection, at an unspecified dose and frequency and Immunoglobulins nos (Immunoglobulin i.v) (intravenous use) for Antibody-mediated rejection, at an unspecified dose and frequency. At the time of the report, TRANSPLANT REJECTION (Antibody-mediated rejection/ vaccine induced rejection in Lung transplant recipient (LTR)) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Biopsy: Did not show any cellular rejection. On an unknown date, Donor specific antibody present: developed new DSAs. On an unknown date, Imaging procedure: Imaging showed new lung infiltrates. On an unknown date, Laboratory test: (Negative) infectious work up was negative. For mRNA-1273 (Spikevax) (Unknown), the reporter considered TRANSPLANT REJECTION (Antibody-mediated rejection/ vaccine induced rejection in Lung transplant recipient (LTR)) to be related. This case was identified during a retrospective clean-up activity initiated under CAPA-036486 in response to a Health Canada Inspection Observation. This case is regarding patient 1 out 2 who took moderna vaccine and had antibody mediated rejection (AMR). No concomitant medication reported. This study was regarding COVID-19 Vaccine triggered rejection in lung transplant recipients. In this series, three 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 second vaccine dose. Evaluation revealed AMR as the underlying etiology. Patients were in ages 50-70 years old, between 6 months and 2 years post-transplant. No previous rejection episodes. All were on standard immunosuppression (IS) as per institution protocols. Two were hospitalized with hypoxic respiratory failure within two weeks of their second vaccine dose. The third 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 were off supplemental O2, the third did not and was relisted for transplant. Author concluded that while LTR had a diminished response to SARS-CoV-2 vaccines making them more vulnerable to the disease, their immune system's response might not always be clear. they report three cases of patients developing severe AMR from new DSAs that appear to be triggered by the COVID-19 vaccine. This vaccine responses should be collected in a data base where each case could be investigated to help better understand the mechanism behind them and hopefully identifying LTR at risk. This could then be used to modify vaccination strategies and aid in preventing adverse outcomes in this vulnerable group of patients. This case was linked to US-MODERNATX, INC.-MOD-2022-790952 (E2B Linked Report). Most recent FOLLOW-UP information incorporated above includes: On 27-Apr-2022: Case was unlocked on 07-Nov-2025 as a part of Health Authority Inspection to perform significant correction, Case was upgraded from invalid to valid, literature citation updated, event verbatim updated, treatment drug coding updated and narrative was updated.; Reporter's Comments: The benefit-risk relationship of product is not affected by this report.; Sender's Comments: US-MODERNATX, INC.-MOD-2022-790952:Patient 2 of 2
Medical History/Concurrent Conditions: Lung transplant
Test Name: Biopsy; Result Unstructured Data: Did not show any cellular rejection; Test Name: DSA; Result Unstructured Data: developed new DSAs; Test Name: Imaging; Result Unstructured Data: Imaging showed new lung infiltrates; Test Name: infectious work up; Test Result: Negative