Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: SARS-CoV-2 breakthrough infection; This literature-non-study case was reported in a literature article and describes the occurrence of COVID-19 (SARS-CoV-2 breakthrough infection) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.   LITERATURE REFERENCE:PRIVACY    Concurrent medical conditions included Haematological malignancy.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced COVID-19 (SARS-CoV-2 breakthrough infection) (seriousness criterion medically significant). At the time of the report, COVID-19 (SARS-CoV-2 breakthrough infection) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered COVID-19 (SARS-CoV-2 breakthrough infection) to be related.    No concomitant and Treatment medications were reported.  The authors described three patients who developed severe or critical COVID-19 infections six months after vaccination. The authors emphasized the importance of routine testing of COVID-19 IgG Spike, semiquantitative antibodies post-vaccination, particularly among immunocompromised patients.   Company comment:  This case concerns a 63-year-old male patient, with underlying hematologic malignancy (the exact disease was not available at this point), who experienced the serious unexpected adverse event of special interest COVID-19 (described as SARS-CoV-2 breakthrough infection). As per provided information, the event occurred approximately 6 months after the patient completed vaccination with the mRNA-1273 vaccine series (dates of vaccinations were not available at the time of this report). Information regarding the clinical course of the event, as well as the outcome of the event were not disclosed according to the available source document. The patient's underlying malignancy remains a confounder for critical (severe) infection. Based on the current available information, the mRNA-1273 vaccine does not contain a virus capable of causing COVID-19 infection after vaccination, therefore, the causality for COVID-19 is not applicable. The benefit-risk relationship of mRNA-1273 is not affected by this report.   This case was linked to MOD-2022-467797 (Patient Link).; Sender's Comments: This case concerns a 63-year-old male patient, with underlying hematologic malignancy (the exact disease was not available at this point), who experienced the serious unexpected adverse event of special interest COVID-19 (described as SARS-CoV-2 breakthrough infection). As per provided information, the event occurred approximately 6 months after the patient completed vaccination with the mRNA-1273 vaccine series (dates of vaccinations were not available at the time of this report). Information regarding the clinical course of the event, as well as the outcome of the event were not disclosed according to the available source document. The patient's underlying malignancy remains a confounder for critical (severe) infection. Based on the current available information, the mRNA-1273 vaccine does not contain a virus capable of causing COVID-19 infection after vaccination, therefore, the causality for COVID-19 is not applicable. The benefit-risk relationship of mRNA-1273 is not affected by this report.