Age: 65.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product VENETOCLAX (VENCLEXTA) for Chronic lymphocytic leukaemia.    Patient had no known allergies, No relevant medical history was reported.  Concomitant products included LEVOFLOXACIN, CETIRIZINE HCL, CALCIUM CITRATE;VITAMIN D NOS, ANASTROZOLE, ALLOPURINOL, ACYCLOVIR [ACICLOVIR], PHOSPHORUS and TOCOPHERYL ACETATE (VITAMIN E [TOCOPHERYL ACETATE]) for an unknown indication.   On 15-Apr-2021, the patient started VENETOCLAX (VENCLEXTA) (Oral) 400 milligram once a day. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In November 2021, the patient experienced COVID-19 (COVID-19). In November 2021, COVID-19 (COVID-19) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In November 2021, SARS-CoV-2 test: (Positive) Positive, Diagnosed with COVID-19.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       In November 2021, the patient experienced covid infection. In November 2021, the Covid infection resolved. Moderna vaccine was also considered suspect.   In Nov 2021 the patient was diagnosed with COVID. Her symptoms were like a light common cold with a positive COVID test. She was doing good as of 16-Nov-2021. She was fully vaccinated with Moderna.  It was unknown if she was enrolled in a COVID-19 vaccine trial.  No treatment medication was provided.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.  Company Comment: This spontaneous case concerns a 65-year-old, female patient with history of co-suspect intake of Venclexta (venetoclax) for Chronic Lymphocytic Leukemia (CLL) of B-cell type (not in remission), who experienced the unexpected, non-serious AESI of COVID-19. The event occurred unknown number of days after intake of Venclexta and unknown number of days after receiving the second dose of the mRNA-1273 vaccine. Of note, the date of intake of Venclexta was reported as 15Apr2021 and the vaccination date of the second dose of the mRNA-1273 vaccine was not reported while the event onset date was reported as unspecified date in Nov2021, hence, the onset latency could not be assessed. It was reported that the patient experienced a light common cold. On an unspecified date in Nov2021, the patient tested positive for SARS-CoV-2 and the patient was diagnosed with COVID-19 infection. Treatment information was not provided. However, the event had resolved at the time of the report. The medical history of carcinoma (CLL), which is a known risk factor for COVID-19, and the history of co-suspect intake of Venclexta, remain as confounders. The patient's advanced age (high risk for infections) also remains a confounder. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a 65-year-old, female patient with history of co-suspect intake of Venclexta (venetoclax) for Chronic Lymphocytic Leukemia (CLL) of B-cell type (not in remission), who experienced the unexpected, non-serious AESI of COVID-19. The event occurred unknown number of days after intake of Venclexta and unknown number of days after receiving the second dose of the mRNA-1273 vaccine. Of note, the date of intake of Venclexta was reported as 15Apr2021 and the vaccination date of the second dose of the mRNA-1273 vaccine was not reported while the event onset date was reported as unspecified date in Nov2021, hence, the onset latency could not be assessed. It was reported that the patient experienced a light common cold. On an unspecified date in Nov2021, the patient tested positive for SARS-CoV-2 and the patient was diagnosed with COVID-19 infection. Treatment information was not provided. However, the event had resolved at the time of the report. The medical history of carcinoma (CLL), which is a known risk factor for COVID-19, and the history of co-suspect intake of Venclexta, remain as confounders. The patient's advanced age (high risk for infections) also remains a confounder. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.