Age: 82.0
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Serology test
Clinical narrative: Covid-19 infection; This literature-non-study case was reported in a literature article and describes the occurrence of COVID-19 (Covid-19 infection) in an 82-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.   Concurrent medical conditions included Chronic obstructive pulmonary disease (Medical Comorbidities : COPD ( Chronic obstructive pulmonary disease )), End stage renal disease (ESRD) (Medical Comorbidities : ESRD on HD ( End-stage renal disease on hemodialysis )) and Hypertension (Medical Comorbidities : HTN ( Hypertension )).   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,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced COVID-19 (Covid-19 infection) (seriousness criteria hospitalization and medically significant). At the time of the report, COVID-19 (Covid-19 infection) was resolving. Possible    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) Ct (Cycle threshold) of32.3 and negative (Negative) Negative. On an unknown date, Serology test (0-1.39): 6.23 nl (abnormal) 6.23 nl and 5.79 nl (abnormal) 5.79 nl.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered COVID-19 (Covid-19 infection) to be possibly related.    No relevant concomitant medications were reported.   No treatment information was provided.  Immune system suppression was No. Presenting symptoms was Dyspnea and weakness. Peak Hospital Level of Care was ICU (intensive care unit ).  This is a regulatory literature non study review case concerning a 82-year-old, patient of unknown gender with medical history of Chronic obstructive pulmonary disease, End stage renal disease (ESRD) on hemodialysis and Hypertension,  who experienced the unexpected serious (hospitalization in ICU and AESI) event of COVID 19 infection. The event occurred approximately 21 days after the second dose of Spikevax. The latency between doses or the start date of the first dose were not disclosed, so although the report states a vaccine breakthrough infection, Lack of efficacy is not captured.   The rechallenge is  not aplicable. The medical history of Chronic obstructive pulmonary disease, End stage renal disease (ESRD) on hemodialysis and Hypertension are confounders for the event and the seriousness (ICU hospitalization).   The benefit-risk relationship of Spikevax is not affected by this report.   This case was linked to MOD-2021-362896, MOD-2021-362916 (Patient Link).; Sender's Comments: This is a regulatory literature non study review case concerning a 82-year-old, patient of unknown gender with medical history of Chronic obstructive pulmonary disease, End stage renal disease (ESRD) on hemodialysis and Hypertension,  who experienced the unexpected serious (hospitalization in ICU and AESI) event of COVID 19 infection. The event occurred approximately 21 days after the second dose of Spikevax. The latency between doses or the start date of the first dose were not disclosed, so although the report states a vaccine breakthrough infection, Lack of efficacy is not captured.   The rechallenge is  not aplicable. The medical history of Chronic obstructive pulmonary disease, End stage renal disease (ESRD) on hemodialysis and Hypertension are confounders for the event and the seriousness (ICU hospitalization).   The benefit-risk relationship of Spikevax is not affected by this report.