Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19 immunisation, Cytomegalovirus test, Cytomegalovirus viraemia, Interchange of vaccine products, Lymphocyte count
Clinical narrative: Cytomegalovirus infection; Interchange of vaccine products; Revaccination with different COVID-19 vaccine; This literature-non-study case was reported in a literature article and describes the occurrence of CYTOMEGALOVIRUS VIRAEMIA (Cytomegalovirus infection) in a 42-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.   LITERATURE REFERENCE:    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for COVID-19 prophylaxis.    The patient's past medical history included Bronchiectasis (Primary disease) and Lung transplant. Concomitant products included TACROLIMUS, MYCOPHENOLATE MOFETIL and PREDNISONE for Immunosuppression.   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form and dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. In 2021, the patient experienced CYTOMEGALOVIRUS VIRAEMIA (Cytomegalovirus infection) (seriousness criterion medically significant), INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products) and COVID-19 IMMUNISATION (Revaccination with different COVID-19 vaccine). The patient was treated with VALGANCICLOVIR (oral) in 2021 at an unspecified dose and frequency. At the time of the report, CYTOMEGALOVIRUS VIRAEMIA (Cytomegalovirus infection) had resolved and INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products) and COVID-19 IMMUNISATION (Revaccination with different COVID-19 vaccine) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Cytomegalovirus test: 15900 international unit per millilitre. In 2021, Lymphocyte count: 1. In 2021, SARS-CoV-2 antibody test: (Negative) Negative and Antibodies not developed. In 2021, White blood cell count: 4.  The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered CYTOMEGALOVIRUS VIRAEMIA (Cytomegalovirus infection), INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products) and COVID-19 IMMUNISATION (Revaccination with different COVID-19 vaccine) to be related.    Relevant concomitant and treatment medications were not reported. Patient experienced Cytomegalovirus infection after 4 days of second dose vaccination. Patient was presented with dyspnea between 1-Mar-2021 to 30-Jun-2021.Time since bilateral lung transplant (allograft) was reported as 22 months. Patient had no prior CMV infection. Cessation of prophylaxis before 1st CMV vaccine was reported as 3 months. No episode of rejection of after vaccination. Time to serum CMV DNA PCR was reported as 42 days.Time from COVID-19 vaccination second dose to positive CMV PCR was reported as 4 days.CMV status of donor was positive while for recipient was negative. Time from last episode of rejection to positive CMV PCR was reported as 1 year 9 months while rejection grade was A2B2R.Patient had the resolution of CMV DNAemia by the censor date with a range of 7-58 days.Therapy included reduction of immunosuppression.  Company comment: This literature-non-study case, concerns a 42-year-old male patient, with reported medical history of Bilateral lung transplant for Bronchiectasis twenty two months back on Immunosuppression, who experienced the unexpected serious (medically significant) event of Cytomegalovirus viraemia that occurred in the context of mRNA-1273 vaccination (dose number not specified). Interchange of vaccine products and Revaccination with different COVID-19 vaccine (vaccination with unspecified dose of co suspect COVID-19 vaccine Tozinameran) was noted in the case. Latency cannot be assessed since vaccination date nor event onset date was disclosed. Patient presented with Dyspnea, with time from second dose of COVID-19 vaccination to positive CMV PCR as four days with no prior CMV infection reported. Time to serum CMV DNA PCR <200 was 42 days with CMV highest serum DNA PCR 15900 IU/mL. Cessation of prophylaxis before first CMV vaccine was reported as three months with no episodes of rejection after vaccination. On admission absolute lymphocyte count was 1 and leukocyte count was 4 with negative SARS-CoV-2 antibody test. Therapy included reduction of immunosuppression 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.   This case was linked to MODERNATX, INC.-MOD-2022-645605, MODERNATX, INC.-MOD-2022-645823 (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 and contains significant information: Reporter information, literature information, Patient details, Medical History, Product and event details updated. Sender's Comments: This literature-non-study case, concerns a 42-year-old male patient, with reported medical history of Bilateral lung transplant for Bronchiectasis twenty two months back on Immunosuppression, who experienced the unexpected serious (medically significant) event of Cytomegalovirus viraemia that occurred in the context of mRNA-1273 vaccination (dose number not specified). Interchange of vaccine products and Revaccination with different COVID-19 vaccine (vaccination with unspecified dose of co suspect COVID-19 vaccine Tozinameran) was noted in the case.  Latency cannot be assessed since vaccination date nor event onset date was disclosed.  Patient presented with Dyspnea, with time from second dose of COVID-19 vaccination to positive CMV PCR as four days with no prior CMV infection reported. Time to serum CMV DNA PCR <200 was 42 days with CMV highest serum DNA PCR 15900 IU/mL. Cessation of prophylaxis before first CMV vaccine was reported as three months with no episodes of rejection after vaccination. On admission absolute lymphocyte count was 1 and leukocyte count was 4 with negative SARS-CoV-2 antibody test. Therapy included reduction of immunosuppression 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. MODERNATX, INC.-MOD-2022-645823:Same Article, 67 yrs, Male. MODERNATX, INC.-MOD-2022-645605:Same Article,  63 yrs, Male.