Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Cough
Clinical narrative: COVID-19 infection; intermittent nonproductive cough; This literature-non-study case was reported in a literature article and describes the occurrence of COVID-19 (COVID-19 infection) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.      The patient's past medical history included Vaccine induced antibody absent (hepatitis B vaccination for a documented history of impaired seroconversion) and Chronic haemodialysis. Previously administered products included for an unreported indication: hepatitis B (hepatitis B vaccination for a documented history of impaired serocoversion) since an unknown date. Concurrent medical conditions included End stage renal disease.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (COVID-19 infection) (seriousness criterion hospitalization prolonged) and COUGH (intermittent nonproductive cough). At the time of the report, COVID-19 (COVID-19 infection) and COUGH (intermittent nonproductive cough) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) rapid antigen testing was positive, positive (Positive) RT-PCR was positive and positive (Positive) Viral genome sequencing revealed a novel SARS-CoV-2 variant of interest (B.1.526).     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered COVID-19 (COVID-19 infection) and COUGH (intermittent nonproductive cough) to be possibly related.    No concomitant information were reported. Treatment information was not provided.  The patient ultimately developed both anti-nucleocapsid IgM & anti-spike IgG antibodies directed against SARS-CoV-2, & viral genome sequencing revealed a novel SARS-CoV-2 variant of interest. He tested positive for COVID-19 via both rapid antigen testing & RT-PCR despite full mRNA- 1273/Moderna SARS-CoV-2 vaccination approximately 2 month prior, & was admitted for inpatient management pending availability of isolated outpatient dialysis. He was afebrile, normoxemic, & clinically stable at presentation & throughout his subsequent hospital course. Following 10 day(d) of uneventful isolation, during which he received thrice-weekly hemodialysis but no COVID-19-specific therapies, he resumed maintenance outpatient dialysis.  Company Comment: This case concerns a 69-year-old male patient with a relevant medical history of End stage renal disease, Haemodialysis and Vaccine induced antibody absent after  Hepatitis B Vaccination, who experienced the unexpected serious event of COVID-19 after mRNA- 1273 Moderna vaccine (Moderna COVID-19 Vaccine / Spikevax). The event occurred approximately 2 months after the second dose of mRNA- 1273 vaccine. Clinical manifestations included productive cough. The disease was mild, patient was admitted due to unavailability of isolated outpatient dialysis. Viral genome sequencing revealed a novel SARS-CoV-2 variant of interest (B.1.526).The rechallenge is not applicable due to the nature of the event. End stage renal disease, Haemodialysis and Vaccine induced antibody absent after  Hepatitis B Vaccination remain a confounder. The benefit-risk relationship of mRNA- 1273 vaccine / Moderna COVID-19 Vaccine is not affected by this report; Sender's Comments: This case concerns a 69-year-old male patient with a relevant medical history of End stage renal disease, Haemodialysis and Vaccine induced antibody absent after  Hepatitis B Vaccination, who experienced the unexpected serious event of COVID-19 after mRNA- 1273 Moderna vaccine (Moderna COVID-19 Vaccine / Spikevax). The event occurred approximately 2 months after the second dose of mRNA- 1273 vaccine. Clinical manifestations included productive cough. The disease was mild, patient was admitted due to unavailability of isolated outpatient dialysis. Viral genome sequencing revealed a novel SARS-CoV-2 variant of interest (B.1.526).The rechallenge is not applicable due to the nature of the event. End stage renal disease, Haemodialysis and Vaccine induced antibody absent after  Hepatitis B Vaccination remain a confounder. The benefit-risk relationship of mRNA- 1273 vaccine / Moderna COVID-19 Vaccine is not affected by this report