Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Gene sequencing, Haemoptysis, SARS-CoV-2 test, Viral load
Clinical narrative: Hemoptysis; SARS-CoV-2 breakthrough infection; This literature-study case was reported in a literature article and describes the occurrence of HAEMOPTYSIS (Hemoptysis) and COVID-19 (SARS-CoV-2 breakthrough infection) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.   LITERATURE REFERENCE: Breakthrough infections with multiple lineages of SARS-CoV-2 variants reveals continued risk of severe disease in immunosuppressed patients. Viruses. 2021;13(9):1743     The patient's past medical history included Lung transplant (Patient is on Immunosuppressive Medication).   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 HAEMOPTYSIS (Hemoptysis) (seriousness criteria hospitalization prolonged and medically significant) and COVID-19 (SARS-CoV-2 breakthrough infection) (seriousness criterion hospitalization prolonged). At the time of the report, HAEMOPTYSIS (Hemoptysis) and COVID-19 (SARS-CoV-2 breakthrough infection) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Gene sequencing: 20j/s:501y.v3/voc-gamma (abnormal) Complete Genome: 20J/S:501Y.V3/VOC-gamma. On an unknown date, SARS-CoV-2 test: positive (Positive) Nasopharyngeal swab positive. On an unknown date, Viral load: 21.4 (abnormal) Viral Load (Ct) 21.4.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered COVID-19 (SARS-CoV-2 breakthrough infection) to be possibly related and HAEMOPTYSIS (Hemoptysis) to be unlikely related.    Patient was reported to be on Immunosuppressive Medication and  presented with symptoms acute hypoxia, acute pneumonia, hemoptysis and was hospitalized with COVID-19 requiring admission to the intensive care unit  Patient had documented records of completing the vaccine regimen at least 14 days prior to testing positive for COVID-19.  Statistical analysis indicates that being elderly (age > 60) (p = 0.0202) and ongoing treatment with immunosuppressive medication (p = 0.047) was significantly associated with severe disease requiring hospitalization after infection.  Lineage of the SARS-CoV-2 in these patients, we performed the ARTIC multiplexing PCR and high-throughput amplicon sequencing of each sample. NextClade Lineage was 20J/S:501Y.V3/VOC-gamma (VOC-Variant of concern). Author concluded that SARS-CoV-2 breakthrough infections with variants of concern in vaccinated individuals, with solid organ transplant recipients and other immunosuppressed or elderly individuals at higher risk for severe disease.   This case concerns a 68-year-old, male patient with a history of Lung transplant (Patient is on Immunosuppressive Medication), who experienced the unexpected serious AESI event of COVID-19 and the unexpected serious event of haemoptysis. The events occurred approximately at an unknown date after the second dose of Moderna COVID-19 vaccine (although vaccination dates are not reported, it is stated that the patient had completed vaccination at least 14 days before COVID-19, but no information about the period between vaccines was provided). The rechallenge was not applicable for heamoptysis since the events happened after the second dose and no additional dosing is expected. The medical history of Lung transplant (Patient is on Immunosuppressive Medication) remains a confounder. The benefit-risk relationship of Moderna COVID-19 vaccine is not affected by this report.   This case was linked to MOD-2021-372517, MOD-2021-372752 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 03-Nov-2021: Follow up received by safety on 03-Nov-2021 included an Email with RA received from Regulatory Authority team. Reporter information, Medical history, treatment, lab data are added.; Sender's Comments: This case concerns a 68-year-old, male patient with a history of Lung transplant (Patient is on Immunosuppressive Medication), who experienced the unexpected serious AESI event of COVID-19 and the unexpected serious event of haemoptysis. The events occurred approximately at an unknown date after the second dose of Moderna COVID-19 vaccine (although vaccination dates are not reported, it is stated that the patient had completed vaccination at least 14 days before COVID-19, but no information about the period between vaccines was provided). The rechallenge was not applicable for heamoptysis since the events happened after the second dose and no additional dosing is expected. The medical history of Lung transplant (Patient is on Immunosuppressive Medication) remains a confounder. The benefit-risk relationship of Moderna COVID-19 vaccine is not affected by this report.