Age: 68.0
Sex: U
Vaccine: COVID19
Symptoms: Breakthrough COVID-19, SARS-CoV-2 antibody test
Clinical narrative: Breakthrough infection; This literature-non-study case was reported in a literature article and describes the occurrence of BREAKTHROUGH COVID-19 (Breakthrough infection) in a 68-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.         The patient's past medical history included Tobacco user (Former tobacco user). Concurrent medical conditions included Malignant neoplasm of thorax (small cell cancer).   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced BREAKTHROUGH COVID-19 (Breakthrough infection) (seriousness criterion hospitalization). At the time of the report, BREAKTHROUGH COVID-19 (Breakthrough infection) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 antibody test: 802.8 U/ml.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant and treatment medications were reported.  Patients with breakthrough SARS-CoV-2 infections experienced documented symptoms during infection.  Histology was reported as small cell  Between April 29 and July 20, 2021, 1001 patients with solid organ or hematologic cancers were enrolled in the cohort study. To examine a more homogeneous patient population, author focused on the subset of patients with thoracic malignancies 242 enrolled in the study.  In this study, authors found that among 242 patients with primary thoracic malignancies who underwent initial vaccination against SARS-CoV-2, there was a marked decline in uptake of each subsequent additional vaccine dose. Specifically, among patients who received an initial mRNA-based vaccination series (mRNA-1273 or BNT162b2), 75 percent of eligible patients received the recommended third dose, 39 percent received the recommended fourth dose, and 5 percent received the recommended fifth dose at the time of data cutoff. Of note, assessed serologic responses in a subset of patients who received booster vaccinations and found that additional vaccinations increased humoral immunity, as expected.  Authors concluded that with the recent recommendation of novel bivalent mRNA-based vaccine booster doses for all individuals over the age of 12, these findings highlight the needed for further understanding of the reasons behind decreased vaccine uptake and emphasized the importance of counseling by providers regarding public health recommendations for patients with lung cancer.  Company Comment: This is a literature non-study case concerning a 68-year-old, patient of unknown gender with medical history of Tobacco user and concurrent medical condition of Malignant neoplasm of thorax (small cell cancer), who experienced the serious (due to hospitalization) unexpected event of breakthrough covid-19. The event occurred 375 days after receiving the first dose of mRNA-1273 vaccine and 191 days after the last dose of dose of mRNA-1273 vaccine. Diagnostic tests include SARS-CoV-2 antibody test of 802.8 U/ml (reference range not provided). No treatment was reported for the event. The outcome of the event was reported as unknown. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   This case was linked to US-MODERNATX, INC.-MOD-2023-712298 (Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 24-Feb-2023: Follow up received by safety on 24-Feb-2023 has email with full text article and contains significant information: Reporter information, literature information, medical history, lab data, suspect details, event details and data were updated.; Sender's Comments: Company Comment: This is a literature non-study case concerning a 68-year-old, patient of unknown gender with medical history of Tobacco user and concurrent medical condition of Malignant neoplasm of thorax (small cell cancer), who experienced the serious (due to hospitalization) unexpected event of breakthrough covid-19. The event occurred 375 days after receiving the first dose of mRNA-1273 vaccine and 191 days after the last dose of dose of mRNA-1273 vaccine. Diagnostic tests include SARS-CoV-2 antibody test of 802.8 U/ml (reference range not provided). No treatment was reported for the event. The outcome of the event was reported as unknown. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. US-MODERNATX, INC.-MOD-2023-712298:61-years-old patient (Master case)