Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Chest X-ray, Computerised tomogram thorax, Lymphocyte count, SARS-CoV-2 test
Clinical narrative: Prolonged symptomatic severe acute respiratory syndrome SARS-CoV-2 infection; This literature-non-study case was reported in a literature article and describes the occurrence of COVID-19 (Prolonged symptomatic severe acute respiratory syndrome SARS-CoV-2 infection) in a 79-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.   LITERATURE REFERENCE:    Previously administered products included for COVID-19 prophylaxis: tixagevimab/cilgavimab (2 months prior.). Past adverse reactions to the above products included No adverse event with tixagevimab/cilgavimab. Concurrent medical conditions included Follicular lymphoma. Concomitant products included LENALIDOMIDE, RITUXIMAB, ZANDELISIB and EPCORITAMAB for Follicular lymphoma.   On an unknown date, the patient received third dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced COVID-19 (Prolonged symptomatic severe acute respiratory syndrome SARS-CoV-2 infection) (seriousness criterion hospitalization). The patient was treated with NIRMATRELVIR;RITONAVIR for COVID-19, at a dose of UNK (21-day course); MOLNUPIRAVIR for COVID-19, at an unspecified dose and frequency and REMDESIVIR for COVID-19, at a dose of UNK (10 days). At the time of the report, COVID-19 (Prolonged symptomatic severe acute respiratory syndrome SARS-CoV-2 infection) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Chest X-ray: remained abnormal during this time. On an unknown date, Computerized tomogram thorax: revealed ground glass opacities and multilobe consolidation. On an unknown date, Lymphocyte count (1.2-4.0): 0.7 K/µL. On an unknown date, SARS-CoV-2 test: Positive, (Positive) continued to have positive tests with cycle threshold (Ct) values of 20-25 six months after initial diagnosis., (Negative) day 28 SARS-CoV-2 PCR remained negative, (Negative) Three months posttreatment remained negative and (Negative) 8 days posttreatment.     For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   It was reported that patient with follicular lymphoma diagnosed 7 years prior to SARS-CoV-2 infection treated with lenalidomide, rituximab, zandelisib, and the investigational therapy epcoritamab in the past 2 years, but with ongoing active disease. The patient had received 3 Moderna SARS-CoV-2 vaccine doses, the last dose 1 year prior to diagnosis of SARS-CoV-2 infection. The patient's first positive SARS-CoV-2 polymerase chain reaction (PCR) test was performed due to cough, shortness of breath, and fatigue; she was treated with molnupiravir. She had received prophylactic tixagevimab/cilgavimab 2 months prior. Symptoms persisted, and she was admitted to the hospital 6 weeks later with persistent positive SARS-CoV-2 PCR results. Absolute lymphocyte count at the time of hospitalization was 0.7 K/µL (reference range, 1.2-4.0 K/µL). She did not require supplemental oxygen, and computed tomographic (CT) chest imaging revealed ground glass opacities and multilobar consolidation. Treatment included 10 days of remdesivir. Symptoms persisted and the patient continued to have positive tests with cycle threshold (Ct) values of 20-25 six months after initial diagnosis. SARS-CoV-2 whole genome sequencing (WGS) revealed lineage BA.1.1 throughout her course. Chest radiography remained abnormal during this time. She never required supplemental oxygen. The patient was treated with a 21-day course of nirmatrelvir/ritonavir. Her respiratory symptoms and fatigue resolved and SARS-CoV-2 PCR was negative 8 days posttreatment. One month posttreatment, she continued to have no respiratory symptoms, and day 28 SARS-CoV-2 PCR remained negative. Three months posttreatment, she continued to have no fevers or respiratory symptoms and SARS-CoV-2 PCR remained negative.  Immunocompromised patients with B-cell deficiencies were at risk for prolonged symptomatic severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection. Treated for B-cell malignancies with Bcell- depleting therapies who developed persistent SARS-CoV- 2 infection and had resolution of symptoms following an extended course of nirmatrelvir/ritonavir.   Company Comment: This literature-non-study case report concerns a 79-year-old female patient with relevant medical history of Follicular lymphoma that has been treating with lenalidomide, rituximab, zandelisib, and epcoritamab, who experienced serious (due to hospitalization) unexpected event of COVID-19. The event occurred approximately one year after the patient had received the third dose of the mRNA-1273 vaccine. The patient's first positive SARS-CoV-2 PCR test was performed due to cough, shortness of breath, and fatigue. The patient was treated with molnupiravir and had received prophylactic tixagevimab/cilgavimab 2 months prior. As symptoms persisted, and she was admitted to the hospital 6 weeks later with persistent positive SARS-CoV-2 PCR results and an extensive workup for other infections was negative. Absolute lymphocyte count at the time of hospitalization was under reference ranges. She did not require supplemental oxygen, and CT chest imaging revealed ground glass opacities and multilobar consolidation. Treatment included 10 days of remdesivir. Symptoms persisted, and the patient continued to have positive tests six months after initial diagnosis. SARS-CoV-2 whole genome sequencing revealed lineage BA.1.1 throughout her course. Chest radiography remained abnormal during this time. Finally, the patient was treated with a 21-day course of nirmatrelvir/ritonavir. Her respiratory symptoms and fatigue resolved, and SARS-CoV-2 PCR was negative 8 days posttreatment. One month posttreatment, she continued to have no respiratory symptoms, and day 28 SARS-CoV-2 PCR remained negative. Three months posttreatment, she continued to have no fevers or respiratory symptoms and SARS-CoV-2 PCR remained negative. The authors suggested that prolonged positivity was related to chronic infection rather than episodes of reinfection. Underlying medical history of follicular lymphoma with B-cell depletion therapy is considered as major confounder for prolonged COVID-19 infection, as these patients are at risk for prolonged infection and are no longer protected by tixagevimab/cilgavimab. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   This case was linked to US-MODERNATX, INC.-MOD-2023-728937, US-MODERNATX, INC.-MOD-2023-728935 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 15-Jun-2023: Follow up received by safety on 16-Jun-2023 has Email with full text article received and contains reporter details, medical history, lab data, vaccination details, concomitant medications, treatment medications, event seriousness added as hospitalization and narrative updated.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-728937:60-Y-Female US-MODERNATX, INC.-MOD-2023-728935:72-YO- Male