Age: 73.0
Sex: U
Vaccine: COVID19
Symptoms: Breakthrough COVID-19, SARS-CoV-2 antibody test
Clinical narrative: Breakthrough SARS-CoV-2 infection; This literature-non-study case was reported in a literature article and describes the occurrence of BREAKTHROUGH COVID-19 (Breakthrough SARS-CoV-2 infection) in a 73-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. Concurrent medical conditions included Squamous cell carcinoma of lung.   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 SARS-CoV-2 infection) (seriousness criteria death and hospitalization). The reported cause of death was Breakthrough SARS-CoV-2 infection. It is unknown if an autopsy was performed.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 antibody test: 128.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment medications were reported.  Patient received an unspecified chemotherapy for thoracic malignancy of squamous cell carcinoma histology. Patient was not hospitalized during infection. Time from initial vaccine dose to SARS-CoV-2 infection was 130 days and last vaccine dose to SARS-CoV-2 infection was 101 days.  Patient deceased following complications of SARS-CoV-2 infection.  Company comment:  This literature-non-study case report concerns  a 73-year-old patient of an unknown gender, who was former smoker with underlying medical history of Squamous cell carcinoma of lung on Chemotherapy, who experienced serious (due to fatal outcome and hospitalization) unexpected event of Breakthrough COVID-19 infection which occurred nearly 4.5 months after initial dose of the mRNA-1273 vaccine (first dose) and nearly 3.5 months after the last (second) mRNA-1273 vaccine. Reportedly, the patient experienced symptoms of COVID-19 infection and required hospitalization. According to the information provided, the patient deceased following complications of SARS-CoV-2 infection, as stated. No additional details regarding clinical course of the event were disclosed. The patient's underlying malignant disease remains a major confounder for complicated SARS-CoV-2 infection that led to fatal outcome. 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, literature information, laboratory data, product details, even details, seriousness and narrative were updated.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-712298:61-years-old patient (Master case); Reported Cause(s) of Death: Breakthrough SARS-CoV-2 infection