Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test, Viral load
Clinical narrative: SARS-CoV-2 breakthrough infection; Lack of drug effect; This literature-study case was reported in a literature article and describes the occurrence of COVID-19 (SARS-CoV-2 breakthrough infection) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.   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 was on Immunosuppressive Medication).   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 COVID-19 (SARS-CoV-2 breakthrough infection) (seriousness criterion hospitalization prolonged) and DRUG INEFFECTIVE (Lack of drug effect). At the time of the report, COVID-19 (SARS-CoV-2 breakthrough infection) and DRUG INEFFECTIVE (Lack of drug effect) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) Positive. On an unknown date, Viral load: 15.7 (abnormal) Viral Load (Cycle threshold) 15.7.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered COVID-19 (SARS-CoV-2 breakthrough infection) and DRUG INEFFECTIVE (Lack of drug effect) to be possibly related.    Concomitant product use was not provided by the reporter.  Patient presented with shortness of breath, fever, chills, body aches, hypoxia and was hospitalized with COVID-19, requiring admission to the intensive care unit (ICU).  Patient had documented records of completing their vaccine regimens 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. These results highlight the importance of ongoing monitoring of the spread of SARS-CoV-2 variants and the need for assessing the immune response to vaccination in immunosuppressed individuals. . CC: This case concerns a 60-year-old female patient with a relevant medical history of Lung transplant undergoing immunosuppressive treatment, who experienced the unexpected serious event/AESI of COVID-19 after mRNA- 1273 Moderna vaccine (Moderna COVID-19 Vaccine / Spikevax). Additionally, Drug ineffective was considered. The event occurred more than 15 days after the second dose of mRNA- 1273 vaccine, exact date unknown. Clinical manifestations included dyspnoea, fever, chills, myalgia and hypoxia. The rechallenge is not applicable due to the nature of the event.  Underlying solid transplant and immunosuppression remain a confounder. The benefit-risk relationship of mRNA- 1273 vaccine / Moderna COVID-19 Vaccine is not affected by this report.   This case was linked to MOD-2021-372517, MOD-2021-372518 (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 and Laboratory data was added; Sender's Comments: This case concerns a 60-year-old female patient with a relevant medical history of Lung transplant undergoing immunosuppressive treatment, who experienced the unexpected serious event/AESI of COVID-19 after mRNA- 1273 Moderna vaccine (Moderna COVID-19 Vaccine / Spikevax). Additionally, Drug ineffective was considered. The event occurred more than 15 days after the second dose of mRNA- 1273 vaccine, exact date unknown. Clinical manifestations included dyspnoea, fever, chills, myalgia and hypoxia. The rechallenge is not applicable due to the nature of the event.  Underlying solid transplant and immunosuppression remain a confounder. The benefit-risk relationship of mRNA- 1273 vaccine / Moderna COVID-19 Vaccine is not affected by this report.