Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Full blood count, Haemoglobin, Myalgia, Platelet count
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of CHRONIC LYMPHOCYTIC LEUKAEMIA (Chronic lymphoid leukemia flare ups) 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. Co-suspect product included non-company product IBRUTINIB (IMBRUVICA) tablet for Chronic lymphoid leukemia. No known allergies. In March 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In March 2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 09-Aug-2021, IBRUTINIB (IMBRUVICA) (Oral) dosage was changed to 420 milligram once a day. On 27-Dec-2021, IBRUTINIB (IMBRUVICA) (Oral) dosage was changed to at an unspecified dose. On an unknown date, the patient started IBRUTINIB (IMBRUVICA) (Oral) at an unspecified dose. On an unknown date, IBRUTINIB (IMBRUVICA) (Oral) dosage was changed to 420 milligram once a day. In 2021, the patient experienced CHRONIC LYMPHOCYTIC LEUKAEMIA (Chronic lymphoid leukemia flare ups) (seriousness criterion medically significant), MYALGIA (Muscle pain), FATIGUE (Feeling extreme fatigue), ARTHRALGIA (Severe joint pain on ankles, knees and thumbs) and ARTHRALGIA (Joint pain). On 04-Jan-2022, the patient experienced ASTHENIA (Felt weak). The patient was treated with PREDNISONE at an unspecified dose and frequency. In 2021, MYALGIA (Muscle pain) had resolved. In November 2021, ARTHRALGIA (Severe joint pain on ankles, knees and thumbs) had resolved. At the time of the report, CHRONIC LYMPHOCYTIC LEUKAEMIA (Chronic lymphoid leukemia flare ups), ASTHENIA (Felt weak) and ARTHRALGIA (Joint pain) outcome was unknown and FATIGUE (Feeling extreme fatigue) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Haemoglobin: Went down from 13.4 to 8.4. In 2021, Platelet count: abnormal. In 2021, White blood cell count: Count was high. In December 2021, Full blood count: blood counts was all normal. In December 2021, White blood cell count: Went up from 12000-18000 most recently. On 23-Dec-2021, Haemoglobin: 8.6. On 23-Dec-2021, Platelet count: 63000. On 30-Dec-2021, Haemoglobin: 8.6. On 30-Dec-2021, Platelet count: 80000. On 30-Dec-2021, White blood cell count: White blood count was 17000. On 04-Jan-2022, Blood test: Abnormal. On an unknown date, Blood iron: Low. On an unknown date, Full blood count: Full blood count was abnormal. On an unknown date, Haemoglobin: Dropped from 13.8 to 9.3 in 1 month, 13.8 g/dL and 8.4 g/dL. On an unknown date, Platelet count: Platelet count continue to decrease, 130000 microliter and 55000 microliter. On an unknown date, White blood cell count: were up to 17,000, 12000 per cubic millimetre and 18000 per cubic millimetre. 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. No concomitant medication was reported. The patient reported that since started Imbruvica, was experiencing muscle and joint pain that was new onset at the start of Imbruvica. The patient reported that, never had experienced joint pain prior to start of Imbruvica. On 04-Jan-2022, he reported that Imbruvica was not working as well as it did before because of joint pain, changes in blood count and felt weak. It was determined that this case was considered a quadruplicates of AER 22K-163-4223263-00. Information from all cases combined into AER 21K-163-4210308-00. This case invalidated. Company comment: This is a spontaneous case reported by a consumer. A 69-year-old male patient in treatment with IBRUTINIB (IMBRUVICA) for Chronic lymphoid leukemia, received 2 doses of mRNA-1273 vaccine and experienced medically significant event of CLL progression. Onset date of the event was not provided, latency cannot be assessed. Diagnostic test results included Haemoglobin decreased from 13.8 g/dL to 8.4 g/dL, Platelet count decreased and White blood cell count increased. In addition, patient experienced non serious events of asthenia, fatigue, myalgia and arthralgia. Treatment included prednisone at an unspecified dose and frequency. IBRUTINIB could be a contributory factor for CLL progression, platelet count decreased, haemoglobin decreased, fatigue, myalgia and arthralgia. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Sender's Comments: This is a spontaneous case reported by a consumer. A 69-year-old male patient in treatment with IBRUTINIB (IMBRUVICA) tablet for Chronic lymphoid leukemia, received 2 doses of mRNA-1273 vaccine and experienced medically significant event of CLL progression. Onset date of the event was not provided, latency cannot be assessed. Diagnostic test results included Haemoglobin decreased from 13.8 g/dL to 8.4 g/dL, Platelet count decreased and White blood cell count increased. In addition, patient experienced non serious events of asthenia, fatigue, myalgia and arthralgia. Treatment included prednisone at an unspecified dose and frequency. IBRUTINIB could be a contributory factor for CLL progression, platelet count decreased, haemoglobin decreased, fatigue, myalgia and arthralgia. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.