Received Jan 21, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA)) | MODERNA | UNK | — | — |
critical COVID-19; This literature-non-study case was reported in a literature article and describes the occurrence of COVID-19 (critical COVID-19) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. LITERATURE REFERENCE: The patient's past medical history included Solid organ transplant (Solid organ transplant recipients). In 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced COVID-19 (critical COVID-19) (seriousness criteria hospitalization and medically significant). The patient was hospitalized on sometime in 2021 due to COVID-19. At the time of the report, COVID-19 (critical COVID-19) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, SARS-CoV-2 test: Positive. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. This case was identified during a retrospective clean-up activity initiated under [withheld] in response to a Health Inspection Observation. This case referred to patient 5 out of 14 patients reported in table 1 who received mRNA-1273 vaccine. Specific concomitant and treatment medications were not reported. The study focused on COVID-19 disease severity in SOTR with COVID-19 vaccine breakthrough infections. Case reports related to SARS-CoV-2 infection following COVID-19 vaccination in SOTR were collected from 07-Apr-2021 to 21-Jun-2021. Vaccine break through infection was defined as the detection of SARSCoV-2 RNA or antigen in a respiratory sample from an individual =14 days after completing all recommended doses of an FDA-authorized COVID-19 vaccine. Individuals who developed COVID-19 <14 days after completing all recommended doses or after the first dose of a two-dose series were considered partially vaccinated. Patients diagnosed with COVID-19 who did not require hospitalization were classified as having mild disease, those requiring hospitalization but not ICU level care were classified as having severe disease, and those requiring ICU level care were categorized as having critical disease. A descriptive analysis of patient factors and variables contributing to critical disease or need for hospitalization were analyzed. All COVID-19 cases were diagnosed by polymerase chain reaction (PCR) testing, none by antigen testing. The most common maintenance immunosuppressive regimens in this cohort included calcineurin inhibitor (CNI) + mycophenolate and steroids + CNI + mycophenolate or azathioprine. COVID-19 occurred after the first vaccine dose in nine cases at a median of 9 days from initial vaccination. COVID19 occurred after the second vaccine dose in 52 cases, of which 43 occurred =14 days postvaccination. The median time to symptom onset from last vaccination among individuals with vaccine breakthrough infection was 34 days. Monoclonal antibodies were administered to 15 SOTR with mild COVID-19, of which casirivimab/imdevimab was given to 14 individuals. Remdesivir was administered to 13 patients with severe disease and five individuals with critical diseases. Convalescent plasma was administered to three patients with critical disease. Thirty-eight SOTR with COVID-19 after vaccination required hospitalization, 17 individuals developed critical illness, and 10 individuals required mechanical ventilation. At the time of reporting, six individuals died. Three of the six deaths occurred in individuals with vaccine breakthrough infection (3/43). Forty-five individuals recovered or were improving following COVID-19 infection, with similar percentages in fully vaccinated and partially vaccinated groups. When comparing individuals who received BNT162b2 or mRNA1273 COVID-19 vaccines, there were no statistically significant differences in hospitalization frequency or critical disease when comparing fully vaccinated and partially vaccinated groups. The study concluded that vaccinated SOTR can develop severe and even critical COVID-19 after vaccination. However, the findings suggested that fully vaccinated SOTR may have lower rates of critical COVID-19 and lower mortality from COVID-19 when compared to unvaccinated SOTR during the later stages of the COVID-19 pandemic. This case was linked to US-MODERNATX, INC.-MOD-2022-662530 (E2B Linked Report).; Reporter's Comments: The benefit-risk relationship of product is not affected by this report.; Sender's Comments: US-MODERNATX, INC.-MOD-2022-662530:Master case (Patient 1 out of 14)
Medical History/Concurrent Conditions: Solid organ transplant (Solid organ transplant recipients)
Test Date: 2021; Test Name: Polymerase chain reaction (PCR) test; Test Result: Positive