Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Computerised tomogram thorax, Lymphocyte count, Oxygen saturation, SARS-CoV-2 test
Clinical narrative: Covid-19 infection; This literature-non-study case was reported in a literature article and describes the occurrence of COVID-19 (Covid-19 infection) in a 72-year-old male patient who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.       Concurrent medical conditions included B-cell lymphoma (large B-cell lymphoma diagnosed 4 years prior to SARS-CoV-2 infection).   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 COVID-19 (Covid-19 infection) (seriousness criterion hospitalization). The patient was treated with NIRMATRELVIR;RITONAVIR at a dose of 1 UNK; NIRMATRELVIR;RITONAVIR at a dose of 1 dosage form and REMDESIVIR at a dose of 1 dosage form. At the time of the report, COVID-19 (Covid-19 infection) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Computerised tomogram thorax: Multifocal ground glass opacities were noted. On an unknown date, Lymphocyte count (1.2-4.0 thousand per microlitre): 0.1 thousand per microlitre. On an unknown date, Oxygen saturation: new hypoxia on home test. On an unknown date, SARS-CoV-2 test: Positive, (Positive) Ct value of 27.5 and (Negative) on day 3 of nirmatrelvir/ritonavir.     For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not provided.  Patient received chimeric antigen receptor T-cell therapy for B-cell lymphoma, 1 year prior with complete response.   Patient had received 2 Moderna SARS-CoV-2 vaccine doses, the most recent dose 18 months prior to SARS-CoV-2 diagnosis. Also, he received prophylactic tixagevimab/cilgavimab 3 months prior to diagnosis.  He initial symptoms as fever and cough and received a 5-day course of nirmatrelvir/ritonavir with mild symptomatic improvement.   One month later, he was admitted as his symptoms progressed. The patient received remdesivir for 10 days followed by nirmatrelvir/ritonavir for 20 days starting on day 7 of remdesivir treatment. The patient's symptoms improved slowly with treatment and no further need for oxygen upon discharge. He had a negative PCR on day 3 of nirmatrelvir/ritonavir and improving cough without fevers, hypoxia, or shortness of breath at the end of his prolonged course. At 2-month follow-up, all respiratory symptoms had resolved.  It was reported that immunocompromised patients with B-cell deficiencies are at risk for prolonged symptomatic severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection.  Author concluded that extended course nirmatrelvir/ritonavir appears to be a potential treatment option for this vulnerable population, assuming no prohibitive drug interactions are present.  Company Comment: This is a literature non-study case concerning a 72-year-old male patient with underlying condition of diffuse large B-cell lymphoma (diagnosed 4 years prior to SARS-CoV-2 infection), no adverse event with prophylactic tixagevimab/cilgavimab 3 months prior, who experienced the serious (due to hospitalization) unexpected event COVID-19 (reported as Covid-19 infection). The event occurred 18 months after the second dose of mRNA-1273 vaccine (vaccine date and event date were not provided). Patient had received chimeric antigen receptor T-cell therapy 1 year prior with complete response. He had fevers and cough and subsequent positive rapid COVID-19 antigen test. He received a 5-day course of nirmatrelvir/ritonavir with mild symptomatic improvement. One month later, he was admitted as his symptoms progressed and he had new hypoxia on home pulse oximetry. Multifocal ground glass opacities were noted on chest Computerized Tomography. SARS-CoV-2 PCR was positive with Ct value of 27.5. Absolute lymphocyte count at the time of diagnosis was 0.1 K/µL (reference range 1.24.0 K/µL). The patient received remdesivir for 10 days followed by nirmatrelvir/ritonavir for 20 days starting on day 7 of remdesivir treatment. The patient's symptoms improved slowly with treatment and no further need for oxygen upon discharge. He had a negative PCR on day 3 of nirmatrelvir/ritonavir and improving cough without fevers, hypoxia, or shortness of breath at the end of his prolonged course. No specimens were available for SARS-CoV-2 sequencing and lineage determination. At 2-month follow-up, all respiratory symptoms had resolved. Concomitant medications were not provided. The patient was treated with nirmatrelvir, ritonavir and remdesivir. At the time of the report, COVID-19 (Covid-19 infection) had resolved.  The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   This case was linked to US-MODERNATX, INC.-MOD-2023-728936 (Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 15-Jun-2023: Follow up received by safety on 16-Jun-2023 has significant information. Reporter and citation details, medical history, lab details, treatment drugs and narrative was updated.; Sender's Comments: Company Comment: This is a literature non-study case concerning a 72-year-old male patient with underlying condition of diffuse large B-cell lymphoma (diagnosed 4 years prior to SARS-CoV-2 infection), no adverse event with prophylactic tixagevimab/cilgavimab 3 months prior, who experienced the serious (due to hospitalization) unexpected event COVID-19 (reported as Covid-19 infection). The event occurred 18 months after the second dose of mRNA-1273 vaccine (vaccine date and event date were not provided). Patient had received chimeric antigen receptor T-cell therapy 1 year prior with complete response. He had fevers and cough and subsequent positive rapid COVID-19 antigen test. He received a 5-day course of nirmatrelvir/ritonavir with mild symptomatic improvement. One month later, he was admitted as his symptoms progressed and he had new hypoxia on home pulse oximetry. Multifocal ground glass opacities were noted on chest Computerized Tomography. SARS-CoV-2 PCR was positive with Ct value of 27.5. Absolute lymphocyte count at the time of diagnosis was 0.1 K/µL (reference range 1.24.0 K/µL). The patient received remdesivir for 10 days followed by nirmatrelvir/ritonavir for 20 days starting on day 7 of remdesivir treatment. The patient's symptoms improved slowly with treatment and no further need for oxygen upon discharge. He had a negative PCR on day 3 of nirmatrelvir/ritonavir and improving cough without fevers, hypoxia, or shortness of breath at the end of his prolonged course. No specimens were available for SARS-CoV-2 sequencing and lineage determination. At 2-month follow-up, all respiratory symptoms had resolved. Concomitant medications were not provided. The patient was treated with nirmatrelvir, ritonavir and remdesivir. At the time of the report, COVID-19 (Covid-19 infection) had resolved.  The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. US-MODERNATX, INC.-MOD-2023-728936:Master case (79-Y-Female)