Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Prostate cancer, Rash, Stress echocardiogram, White blood cell count
Clinical narrative: His bloodwork showed he had possible prostate cancer; unconfirmed heart attack; Stroke; Gout; Generalised spasm; Chest pain; Generalized rash; Localised rash; Ankle swelling; This spontaneous case was reported by a consumer and describes the occurrence of PROSTATE CANCER (His bloodwork showed he had possible prostate cancer), MYOCARDIAL INFARCTION (unconfirmed heart attack) and CEREBROVASCULAR ACCIDENT (Stroke) in a 54-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 lymphocytic leukemia.    The patient's past medical history included Alcohol use on 11-Oct-2021 and Mobility decreased (something happened with his left arm, he could not put up his left side arm and did not seek out emergency response.) on 06-Apr-2021.   On 14-Oct-2020, the patient IBRUTINIB (IMBRUVICA) (Oral) dosage was changed to at an unspecified dose. On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Apr-2021, IBRUTINIB (IMBRUVICA) (Oral) dosage was changed to at an unspecified dose. On 15-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started IBRUTINIB (IMBRUVICA) (Oral) at an unspecified dose. On 11-Oct-2021, the patient experienced JOINT SWELLING (Ankle swelling) and RASH (Localised rash). On an unknown date, the patient experienced PROSTATE CANCER (His bloodwork showed he had possible prostate cancer) (seriousness criterion medically significant), MYOCARDIAL INFARCTION (unconfirmed heart attack) (seriousness criterion medically significant), CEREBROVASCULAR ACCIDENT (Stroke) (seriousness criterion medically significant), GOUT (Gout), MUSCLE SPASMS (Generalised spasm), CHEST PAIN (Chest pain) and RASH (Generalized rash). At the time of the report, PROSTATE CANCER (His bloodwork showed he had possible prostate cancer) had not resolved, MYOCARDIAL INFARCTION (unconfirmed heart attack), CEREBROVASCULAR ACCIDENT (Stroke) and RASH (Generalized rash) had resolved and GOUT (Gout), JOINT SWELLING (Ankle swelling), MUSCLE SPASMS (Generalised spasm), CHEST PAIN (Chest pain) and RASH (Localised rash) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In November 2021, White blood cell count: 39.4 no unit. On an unknown date, Blood pressure measurement: Increased. On an unknown date, Blood test: bloodwork showed he had possible prostate cancer. On an unknown date, Full blood count: Abnormal. On an unknown date, Heart rate: Heart racing,Increased resting heart rate. On an unknown date, Stress echocardiogram: no findings other than being out of shape. On an unknown date, White blood cell count: 78 No unit, 19 No unit and 10 No unit.         He had gout after beginning Imbruvica. Imbruvica had made his heart rate increased and caused palpitations. He did not take Imbruvica as prescribed by his doctor. Oncologist stated that Imbruvica worked well for him at the beginning. He could not tolerate the medication because his heart would race.  formulation for IMBRUVICA was 420 Milligram Tablet.  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 is a spontaneous case reported by a consumer. A 54-year-old male patient completed a two-dose primary series of mRNA-1273 vaccine with an interval of 30 days and experienced chest cramping, increased heart rate and increased blood pressure resulting in an unconfirmed heart attack or stroke. His blood work showed he had possible prostate cancer. Onset date of the events was not provided; hence, latency cannot be assessed. In addition, patient experienced non serious events of rash and swelling on his right ankle approximately 4 months after last vaccination. Non serious events of gout, generalised spasm, generalized rash and chest pain were also reported. On an unknown date, he had an stress echocardiogram related to heart racing and increased resting heart rate with no findings other than being out of shape. Other diagnostic test results performed on an unknown date included full blood count: abnormal; white blood cell count: 78, 19 and 10 (no unit), and white blood cell count 39.4 four months after last vaccination. Relevant concurrent medical conditions included Chronic lymphocytic leukemia which represents a risk factor for second primary cancers including prostate cancers. Regarding IBRUTINIB (IMBRUVICA), reported as co-suspect, could be a contributory factor for chest pain, increased heart rate, increased blood pressure, myocardial infarction, stroke, generalised spasm, gout, blood count abnormal and generalized rash. Patient stated that IMBRUVICA had made his heart rate increased and caused palpitations. No further details regarding clinical course, diagnostic tests or treatment performed were disclosed. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   This case was linked to MOD-2021-623868 (Patient Link).; Sender's Comments: This is a spontaneous case reported by a consumer. A 54-year-old male patient completed a two-dose primary series of mRNA-1273 vaccine with an interval of 30 days and experienced chest cramping, increased heart rate and increased blood pressure resulting in an unconfirmed heart attack or stroke. His blood work showed he had possible prostate cancer. Onset date of the events was not provided; hence, latency cannot be assessed. In addition, patient experienced non serious events of rash and swelling on his right ankle approximately 4 months after last vaccination. Non serious events of gout, generalised spasm, generalized rash and chest pain were also reported. On an unknown date, he had an stress echocardiogram related to heart racing and increased resting heart rate with no findings other than being out of shape. Other diagnostic test results performed on an unknown date included full blood count: abnormal; white blood cell count: 78, 19 and 10 (no unit), and white blood cell count 39.4 four months after last vaccination. Relevant concurrent medical conditions included Chronic lymphocytic leukemia which represents a risk factor for second primary cancers including prostate cancers. Regarding IBRUTINIB (IMBRUVICA), reported as co-suspect, could be a contributory factor for chest pain, increased heart rate, increased blood pressure, myocardial infarction, stroke, generalised spasm, gout, blood count abnormal and generalized rash. Patient stated that IMBRUVICA had made his heart rate increased and caused palpitations. No further details regarding clinical course, diagnostic tests or treatment performed were disclosed.The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.