Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: White blood cell count
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 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.   LITERATURE REFERENCE:     The patient's past medical history included Idiopathic pulmonary fibrosis (Primary disease.) and Lung transplant (18 month since Right lung transplant.). Concomitant products included PREDNISONE and TACROLIMUS for Immunosuppression.    In 2021, 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 criterion medically significant). The patient was treated with GANCICLOVIR (intravenous) at an unspecified dose and frequency and VALGANCICLOVIR (oral) at an unspecified dose and frequency. In 2021, PNEUMONIA CYTOMEGALOVIRAL (CMV pneumonitis) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Blood immunoglobulin G: Patient not developed immunoglobulin G  antibodies to SARS-CoV-2 in response to vaccination.. In 2021, Lymphocyte count: Admission absolute lymphocyte count was 0.88.. In 2021, Polymerase chain reaction: 175973 international unit per millilitre CMV highest serum DNA PCR was 175973. In 2021, SARS-CoV-2 antibody test: (Negative) Negative. In 2021, White blood cell count: Admission leukocyte count was 5.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered PNEUMONIA CYTOMEGALOVIRAL (CMV pneumonitis) to be related.    It was reported that study was conducted between 01-Mar-2021 and 30-Jun-2021. Cytomegalovirus (CMV) status of donor was positive, and recipient was negative. Presenting symptoms was reported as dyspnea and cough. Time to serum CMV DNA PCR was reported as 45 days. No Prior CMV infection was reported. Cessation of prophylaxis before first CMV vaccine was reported as 2 months. No episode of Rejection after vaccination was reported. Time from last episode of rejection to positive CMV PCR (rejection grade) was reported as 1 year 2 months. Time from COVID-19 vaccination second dose to positive CMV PCR, was reported as 5 days. Patient was not on CMV prophylaxis for at least 2 months before COVID-19 vaccination. Patient did not have CMV infections between the end of prophylaxis and the occurrence of CMV DNAemia after vaccination. Patient had the resolution of CMV DNAemia by the censor date with a range of 7-58 day. Therapy included reduction of immunosuppression, intravenous ganciclovir, and oral valganciclovir. None of the recipients developed immunoglobulin G antibodies to SARS-CoV-2 in response to vaccination. There were no documented cases of COVID-19 in these transplant recipients.   This case was linked to US-MODERNATX, INC.-MOD-2022-645605, US-MODERNATX, INC.-MOD-2022-645823, US-MODERNATX, INC.-MOD-2022-645826, US-MODERNATX, INC.-MOD-2022-645825 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 15-Sep-2022: Follow up received by safety on 15-SEP-2022 has Email received and contains significant information: Reporter information, literature information, medical History, laboratory tests, product details event details updated.  Company Comment: This literature-non-study case, concerns a 70-year-old female patient, with reported medical history of Right Lung transplant for Idiopathic pulmonary fibrosis 18 months back on Immunosuppression. who experienced the unexpected serious (medically significant) event of Pneumonia cytomegaloviral that occurred in the context of second dose of mRNA-1273 vaccination. Latency cannot be assessed since vaccination date nor event onset date was disclosed. Patient presented with symptoms of dyspnoea and cough. Time from second dose of COVID-19 vaccination to positive CMV PCR, was reported as 5 days with no prior CMV infection reported. Time to serum CMV DNA PCR <200 was 45 days with CMV highest serum DNA PCR 175 973 IU/mL. Cessation of prophylaxis before first CMV vaccine was reported as 2 months with no episodes of rejection after vaccination. On admission absolute lymphocyte count was 0.88 and leukocyte count was 5 with negative SARS-CoV-2 antibody test. Therapy included reduction of immunosuppression, intravenous ganciclovir and oral valganciclovir. Patient had the resolution of CMV DNAemia by the censor date with a range of 7-58 day.  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.; Sender's Comments: This literature-non-study case, concerns a 70-year-old female patient, with reported medical history of Right Lung transplant for Idiopathic pulmonary fibrosis 18 months back on Immunosuppression. who experienced the unexpected serious (medically significant) event of Pneumonia cytomegaloviral that occurred in the context of second dose of mRNA-1273 vaccination. Latency cannot be assessed since vaccination date nor event onset date was disclosed. Patient presented with symptoms of dyspnoea and cough. Time from second dose of COVID-19 vaccination to positive CMV PCR, was reported as 5 days with no prior CMV infection reported. Time to serum CMV DNA PCR <200 was 45 days with CMV highest serum DNA PCR 175 973 IU/mL. Cessation of prophylaxis before first CMV vaccine was reported as 2 months with no episodes of rejection after vaccination. On admission absolute lymphocyte count was 0.88 and leukocyte count was 5 with negative SARS-CoV-2 antibody test. Therapy included reduction of immunosuppression, intravenous ganciclovir and oral valganciclovir. Patient had the resolution of CMV DNAemia by the censor date with a range of 7-58 day.  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-2022-645605:Same Article: 63 yrs, Male US-MODERNATX, INC.-MOD-2022-645826:Same Article, 42 yrs, male US-MODERNATX, INC.-MOD-2022-645825:Same Article, 56 yrs, Female