Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Drug intolerance, Gout, Heart rate, Inappropriate schedule of product administration, Medication error
Clinical narrative: HEART ATTACK; STROKE; POSSIBLE PROSTATE CANCER; GOUT; CRAMPING ON THE CHEST AREA AND GENERAL MUSCLE CRAMPING; CHEST PAIN; IMBRUVICA NOT TAKEN AS PRESCRIBED; COULD NOT TOLERATE THE MEDICATION BECAUSE HEART WOULD RACE/ELEVATED HEART RATE; MEDICATION ERROR; SIDE EFFECTS; DIFFUSE RASH; COULD NOT PUT UP LEFT SIDE ARM; This spontaneous case was reported by a consumer and describes the occurrence of MYOCARDIAL INFARCTION (HEART ATTACK), CEREBROVASCULAR ACCIDENT (STROKE) and PROSTATE CANCER (POSSIBLE PROSTATE CANCER) 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.   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 an unknown date, the patient started IBRUTINIB (IMBRUVICA) (Oral) at an unspecified dose. On 06-Apr-2021, the patient experienced MOBILITY DECREASED (COULD NOT PUT UP LEFT SIDE ARM). On an unknown date, the patient experienced MYOCARDIAL INFARCTION (HEART ATTACK) (seriousness criterion medically significant), CEREBROVASCULAR ACCIDENT (STROKE) (seriousness criterion medically significant), PROSTATE CANCER (POSSIBLE PROSTATE CANCER) (seriousness criterion medically significant), GOUT (GOUT), MUSCLE SPASMS (CRAMPING ON THE CHEST AREA AND GENERAL MUSCLE CRAMPING), CHEST PAIN (CHEST PAIN), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (IMBRUVICA NOT TAKEN AS PRESCRIBED), DRUG INTOLERANCE (COULD NOT TOLERATE THE MEDICATION BECAUSE HEART WOULD RACE/ELEVATED HEART RATE), MEDICATION ERROR (MEDICATION ERROR), ADVERSE DRUG REACTION (SIDE EFFECTS) and RASH (DIFFUSE RASH). At the time of the report, MYOCARDIAL INFARCTION (HEART ATTACK), CEREBROVASCULAR ACCIDENT (STROKE), PROSTATE CANCER (POSSIBLE PROSTATE CANCER) and RASH (DIFFUSE RASH) had resolved, GOUT (GOUT), MOBILITY DECREASED (COULD NOT PUT UP LEFT SIDE ARM), MUSCLE SPASMS (CRAMPING ON THE CHEST AREA AND GENERAL MUSCLE CRAMPING), CHEST PAIN (CHEST PAIN), DRUG INTOLERANCE (COULD NOT TOLERATE THE MEDICATION BECAUSE HEART WOULD RACE/ELEVATED HEART RATE), MEDICATION ERROR (MEDICATION ERROR) and ADVERSE DRUG REACTION (SIDE EFFECTS) outcome was unknown and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (IMBRUVICA NOT TAKEN AS PRESCRIBED) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: Increased. On an unknown date, Blood test: possible prostate cancer. On an unknown date, Heart rate: heart racing and 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, 19 and 10.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication was not reported.  The patient experienced chest cramping, increased heart rate and increased blood pressure resulting in an unconfirmed heart attack or stroke. His bloodwork showed he had possible prostate cancer. 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. He had stress echocardiogram related to heart racing and increased resting heart rate with no findings other than being out of shape. Adverse event Information provided by him was related to covid vaccine. On 06-Apr-2021, something happened with his left arm, he could not put up his left side arm and did not seek out emergency response. He went to seek primary care to explain the side effects. They agreed with reducing dose and they told him that he would take it for three years. He went back to his Oncologist on the 08-Jun-2021. He stated that IMBRUVICA worked well for him at the beginning. He could not tolerate the medication because his heart would race. He also experienced rash and swelling on his right ankle on 11-Oct-2021.  It was unknown if he was enrolled in a COVID-19 vaccine Trial.  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.   This case was linked to MOD-2021-624203 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 07-Dec-2021: Live significant follow-up attached. Events and lab data added.; Sender's Comments: This is a spontaneous case concerning a 54-year-old male patient with medical history of Chronic lymphocytic leukemia, who experienced the unexpected, serious (medically significant) adverse events of special interest of Myocardial infarction, Cerebrovascular accident and the unexpected, serious (medically significant) event of Prostate cancer, after receiving the second dose of mRNA-1273 vaccine. On unknown date, the patient experienced chest cramping, increased heart rate and increased blood pressure resulting in an unconfirmed heart attack or stroke. His bloodwork showed he had possible prostate cancer. Stress echocardiogram showed no findings other than being out of shape. Clinical course, other relevant diagnostic tests and further treatment details were not provided in the case. At the time of the report, the events Myocardial infarction and Cerebrovascular accident had resolved while the event Prostate cancer had not resolved. Medical history of Chronic lymphocytic leukemia remains a risk factor for the events. The benefit-risk relationship of mRNA-1273 is not affected by this report.