Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Blood immunoglobulin G, Lymphocyte count, Pneumonia cytomegaloviral, Polymerase chain reaction, SARS-CoV-2 antibody test
Clinical narrative: CMV pneumonitis; This literature-non-study case was reported in a literature article and describes the occurrence of PNEUMONIA CYTOMEGALOVIRAL (CMV pneumonitis) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.   LITERATURE REFERENCE:     The patient's past medical history included Lung transplant. Concurrent medical conditions included Idiopathic pulmonary fibrosis. Concomitant products included TACROLIMUS, MYCOPHENOLATE MOFETIL (MYCOPHENOLATE) and PREDNISONE for Immunosuppression.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PNEUMONIA CYTOMEGALOVIRAL (CMV pneumonitis) (seriousness criteria hospitalization and medically significant). The patient was treated with GANCICLOVIR (intravenous) at an unspecified dose and frequency and VALGANCICLOVIR (oral) at an unspecified dose and frequency. At the time of the report, PNEUMONIA CYTOMEGALOVIRAL (CMV pneumonitis) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood immunoglobulin G: did not develop immunoglobulin G antibodies to SARS-CoV-2 in response to vaccination. On an unknown date, Lymphocyte count: 1.04. On an unknown date, Polymerase chain reaction: 164000 international unit per millilitre. On an unknown date, SARS-CoV-2 antibody test: (Negative) Negative. On an unknown date, White blood cell count: 2.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered PNEUMONIA CYTOMEGALOVIRAL (CMV pneumonitis) to be related.    It was reported that donor cytomegalovirus status was positive and recipient status was negative. Cessation of prophylaxis before first CMV vaccine was reported as 2 months. Patient was not on CMV prophylaxis for at least 2 months before COVID-19 vaccination..  Patient was asymptomatic. CMV (Cytomegalovirus) disease state was reported as CMV Viremia. Time to serum CMV DNA PCR was reported as 30 days. Time from COVID-19 vaccination second dose to positive CMV PCR, was reported as 16 days. All patients were off antiviral prophylaxis either because of center or program protocol or  because of intolerance of prophylactic medications due to cytopenias, and they were on their standard immunosuppressive regimen at the time of vaccination. There were no documented cases of COVID-19 in these transplant recipients.  Authors discussed that by virtue of its observational nature, their study was  unable to draw a causal association between vaccination and CMV infections. However, all cases of CMV DNAemia described in their case series occurred in close temporal relation to patients receiving the mRNA-1273  COVID-19 mRNA vaccines supporting a strong possible role. None of these patients had CMV infections between the end of prophylaxis and the occurrence of CMV DNAemia after vaccination. Also, there was no rejection diagnosed in the 2 months before CMV DNAemia, and thus augmentation of immunosuppression was not a contributing factor to CMV reactivation.  Authors concluded that  the riskbenefit assessment strongly favors COVID-19 vaccination for solid organ recipients. However, an increased awareness of a potentially associated risk of CMV reactivation may help care teams to more rapidly diagnose and manage this  complication or perhaps consider short-term reinstitution of viral prophylaxis around the time of vaccination.   This case was linked to US-MODERNATX, INC.-MOD-2022-645823, US-MODERNATX, INC.-MOD-2022-645826, US-MODERNATX, INC.-MOD-2022-645605, US-MODERNATX, INC.-MOD-2022-645825, US-MODERNATX, INC.-MOD-2022-645605 (E2B Linked Report).  Company comment: This literature-non-study case, concerns a 63-year-old male patient, with reported medical history idiopathic pulmonary fibrosis who underwent right lung transplant 3 years before COVID-19 vaccination and was clinically well, who experienced the unexpected serious (medically significant/hospitalization) event of Pneumonia cytomegaloviral that occurred in the context of second dose of mRNA-1273 vaccination. Sixteen days after his second dose of the mRNA-1273 vaccine he developed generalized malaise and a slightly elevated temperature of 37.2 °C (99 °F). He presented to the emergency department with dyspnea and acute hypoxemia. His prophylactic valganciclovir was stopped 24 months after transplant as per institutional protocol. He underwent bronchoscopy with transbronchial biopsies which demonstrated CMV pneumonitis with no evidence of acute cellular rejection. On admission absolute lymphocyte count was 1.04 and leukocyte count was 2 with negative SARS-CoV-2 antibody test. His admission blood CMV DNA PCR was 164 000 IU/ml. Treatment with intravenous ganciclovir reduced the CMV DNAemia to 69 000 IU/ml within a week. Reduction in CMV viral load was accompanied by clinical improvement. One week after discharge, he required readmission with worsening respiratory failure requiring mechanical ventilation. His CMV PCR was 707 IU/ml, and he was treated for presumed acute cellular rejection with high-dose intravenous corticosteroids with eventual liberation from mechanical ventilation. Two weeks after the second discharge, his blood CMV PCR was <200 IU/ml, and he was transitioned from intravenous ganciclovir to oral valganciclovir. The riskbenefit assessment strongly favors COVID-19 vaccination for solid organ recipients, however, an increased awareness of a potentially associated risk of CMV reactivation may help care teams to more rapidly diagnose and manage this complication or perhaps consider short-term reinstitution of viral prophylaxis around the time of vaccination. The benefit-risk relationship of mRNA-1273 is not affected by this report.   Most recent FOLLOW-UP information incorporated above includes: On 15-Sep-2022: Live follow up was received by safety on 15-SEP-2022 has Email with FTA and contains significant information: Reporter information, citation details, medical history, lab data, treatment medications, event details and clinical course details were updated.; Sender's Comments: This literature-non-study case, concerns a 63-year-old male patient, with reported medical history idiopathic pulmonary fibrosis who underwent right lung transplant 3 years before COVID-19 vaccination and was clinically well, who experienced the unexpected serious (medically significant/hospitalization) event of Pneumonia cytomegaloviral that occurred in the context of second dose of mRNA-1273 vaccination. Sixteen days after his second dose of the mRNA-1273 vaccine he developed generalized malaise and a slightly elevated temperature of 37.2 °C (99 °F). he presented to the emergency department with dyspnea and acute hypoxemia. His prophylactic valganciclovir was stopped 24 months after transplant as per institutional protocol. He underwent bronchoscopy with transbronchial biopsies which demonstrated CMV pneumonitis with no evidence of acute cellular rejection. On admission absolute lymphocyte count was 1.04 and leukocyte count was 2 with negative SARS-CoV-2 antibody test. His admission blood CMV DNA PCR was 164 000 IU/ml. Treatment with intravenous ganciclovir reduced the CMV DNAemia to 69 000 IU/ml within a week. Reduction in CMV viral load was accompanied by clinical improvement. One week after discharge, he required readmission with worsening respiratory failure requiring mechanical ventilation. His CMV PCR was 707 IU/ml, and he was treated for presumed acute cellular rejection with high-dose intravenous corticosteroids with eventual liberation from mechanical ventilation. Two weeks after the second discharge, his blood CMV PCR was <200 IU/ml, and he was transitioned from intravenous ganciclovir to oral valganciclovir. The riskbenefit assessment strongly favors COVID-19 vaccination for solid organ recipients, however, an increased awareness of a potentially associated risk of CMV reactivation may help care teams to more rapidly diagnose and manage this complication or perhaps consider short-term reinstitution of viral prophylaxis around the time of vaccination. The benefit-risk relationship of mRNA-1273 is not affected by this report. US-MODERNATX, INC.-MOD-2022-645823:Same Article, 67 yrs, male US-MODERNATX, INC.-MOD-2022-645826:Same Article, 42 yrs, male US-MODERNATX, INC.-MOD-2022-645605:Same Article, 63yrs, male US-MODERNATX, INC.-MOD-2022-645825:Same Article, 56 yrs, female US-MODERNATX, INC.-MOD-2022-645605:Same Article, 63yrs, male