Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Cancer screening, Chronic lymphocytic leukaemia, Fatigue, Platelet count
Clinical narrative: Was really tired after the COVID injection for two days; Arm was sore for 48 hours; Chronic lymphocytic leukemia cancer 0.6; Tired; Increasing back pain; This spontaneous case was reported by a consumer and describes the occurrence of CHRONIC LYMPHOCYTIC LEUKAEMIA (Chronic lymphocytic leukemia cancer 0.6) in a 72-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.    Co-suspect product included non-company product VENETOCLAX (VENCLEXTA) tablet for Chronic lymphocytic leukemia.    Concurrent medical conditions included Chronic lymphocytic leukemia, Tobacco user, Alcohol use (Alcohol user), Penicillin allergy, Drug allergy (ACE INHIBITORS allergy manifested by hives) and Pollen allergy (manifested by sneezing/runny nose/watery eyes).   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 27-Aug-2021, the patient started VENETOCLAX (VENCLEXTA) (Oral) 400 milligram once a day. On 01-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In 2021, the patient experienced BACK PAIN (Increasing back pain). On 01-Sep-2021, the patient experienced CHRONIC LYMPHOCYTIC LEUKAEMIA (Chronic lymphocytic leukemia cancer 0.6) (seriousness criterion medically significant). On 08-Sep-2021, the patient experienced FATIGUE (Was really tired after the COVID injection for two days) and VACCINATION SITE PAIN (Arm was sore for 48 hours). In September 2021, the patient experienced FATIGUE (Tired). In September 2021, FATIGUE (Was really tired after the COVID injection for two days), VACCINATION SITE PAIN (Arm was sore for 48 hours) and FATIGUE (Tired) had resolved. At the time of the report, CHRONIC LYMPHOCYTIC LEUKAEMIA (Chronic lymphocytic leukemia cancer 0.6) was resolving and BACK PAIN (Increasing back pain) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Cancer screening: 0.6. On 01-Sep-2021, Cancer screening: 0.7. On 01-Sep-2021, Platelet count: 75, low count. On 01-Sep-2021, White blood cell count: 2.8, low count. On 25-Oct-2021, Platelet count: 122, abnormal. On 25-Oct-2021, White blood cell count: 3.5, abnormal.         No treatment medication was reported.  Patient was unable to provide concomitant medications since the list was not available during the time of the call. The patient was taking about nine to ten medications while on Venclexta.  The reporter's causality for the events of chronic lymphocytic leukemia cancer 0.6 was not provided. The reporter's causality for the events of arm was sore for 48 hours and was really tired after the COVID injection for two days and increasing back pain with Venclexta (venetoclax) was no reasonable possibility. The reporter's causality for the events of tired with Venclexta (venetoclax) was a reasonable possibility.  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 is a spontaneous case reported by a consumer. A 72-year-old male patient in treatment with VENETOCLAX (VENCLEXTA) for Chronic lymphocytic leukemia, received 3 doses of  mRNA-1273 vaccine and experienced medically significant event of  Chronic lymphocytic leukemia on the same day after receiving third dose. In addition, patient experienced non serious events of vaccination site pain and fatigue 7 days after receiving third dose. On an unknown date, he experienced Increasing back pain which he related to return to work four hours at a time standing and walking on concrete floors. Diagnostic test results included platelet count: 75, white blood cell count: 2.8 on the same day of third vaccination; and platelet count: 122, white blood cell count: 3.5 54 days after third vaccination. No further details regarding clinical course, diagnostic tests or treatment performed were disclosed. VENETOCLAX is a confounding factor for back pain and chronic lymphocytic leukemia. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   Most recent FOLLOW-UP information incorporated above includes: On 22-Oct-2021: Follow-up received: Medical history, lab data start date, suspect's start date and action taken, event start date and stop date was added, event Cancer was updated to Chronic lymphocytic leukemia cancer 0.7, event Tired was added and causality for Humira was updated. On 12-Nov-2021: Follow-up received: Lab data, event verbatim for Chronic lymphocytic leukemia cancer, additional event of Back pain and narrative was updated.; Sender's Comments: This is a spontaneous case reported by a consumer. A 72-year-old male patient in treatment with VENETOCLAX (VENCLEXTA) for Chronic lymphocytic leukemia, received 3 doses of  mRNA-1273 vaccine and experienced medically significant event of  Chronic lymphocytic leukemia on the same day after receiving third dose. In addition, patient experienced non serious events of vaccination site pain and fatigue 7 days after receiving third dose. On an unknown date, he experienced Increasing back pain which he related to return to work four hours at a time standing and walking on concrete floors. Diagnostic test results included platelet count: 75, white blood cell count: 2.8 on the same day of third vaccination; and platelet count: 122, white blood cell count: 3.5 54 days after third vaccination. No further details regarding clinical course, diagnostic tests or treatment performed were disclosed. VENETOCLAX is a confounding factor for back pain and chronic lymphocytic leukemia. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.