Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Coronary artery occlusion, Dyspepsia, Echocardiogram, Electrocardiogram, Heart rate
Clinical narrative: left anterior descending cardiac artery occlusion; Heart attack; pain in neck; pain in back; pain in left arm; chest tightness; indigestion; nausea; artery was not functioning; abnormal blood flow; Heart rate increased; left arm pain radiating to wrist; This is a solicited report from a contactable consumer (patient) based on the information received by Pfizer from other manufacturer (Mfr. Control No.: 21K-163-3929345-00).   A 69-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 intramuscular on 09Feb2021 (Batch/Lot number was not reported) at the age of 69-year-old as single dose for covid-19 immunisation; adalimumab (HUMIRA, 40 mg, Solution for injection in pre-filled pen), subcutaneous from 17Dec2018 (Batch/Lot number was not reported) and ongoing at 40 mg, (1 in 14 D) for ankylosing spondylitis, seronegative rheumatoid arthritis sicca complex and sjogren's syndrome.  Medical history included abstains from alcohol, no tobacco use, sjogren's syndrome, latex allergy manifested by nasal discharge/watery eyes, codeine allergy manifested by lightheadedness/unable to focus, acute idiopathic osteoporosis, ankylosing spondylitis, arthritis, chronic heart disease, seronegative rheumatoid arthritis sicca complex, stent and balloon placement for the left anterior descending artery occlusion. Concomitant medications included aspirin (81 mg) for chronic heart disease; folic acid taken for ankylosing spondylitis and arthritis,; methotrexate taken for ankylosing spondylitis and arthritis; sulfasalazine taken for ankylosing spondylitis and arthritis; denosumab (PROLIA); nabumetone (NABUTONE); calcium carbonate; magnesium; biotin; krill oil; vitamin d nos; ciclosporin (RESTASIS). The patient had other concomitant therapy of multivitamin. The patient previously took BNT162B2 (lot# EL3248), dose 1 via intramuscular on 14Jan2021 for covid-19 vaccination at the age of 69-year-old. In 2021, the patient experienced heart rate increased, left arm pain radiating to wrist. On 22Apr2021, the patient experienced artery was not functioning, left anterior descending cardiac artery occlusion, heart attack and electrocardiogram showed abnormal blood flow. PFIZER BIONTECH covid-19 vaccine (tozinameran) was also considered suspect. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. On 14Jan2021, patient received first dose COVID-19 Vaccine manufactured by Pfizer, lot number EL3248. On 09Feb2021, she received second dose COVID-19 Vaccine manufactured by Pfizer. In late Feb2021 or early Mar2021, she started to experience symptoms such as pain in neck, back, left arm and radiating to wrist, chest tightness which was described as feeling of indigestion, nausea and increased or accelerated heart rate. On 22Apr2021, she was admitted due to a diagnosis of heart attack and 100 percent occlusion of left anterior descending artery. Physician informed to her that heart attack and occlusion of the artery probably started between two weeks and two months prior to being admitted but was confirmed only on 22Apr2021 upon being hospitalized. Patient stayed in the hospital until 26Apr2021 and went back on 28Apr2021 to had stent and balloon placement for the left anterior descending artery occlusion done after tests confirmed that she could have the procedure. She was sent home same day after stent and balloon placement. On 25Jul2021, she had done last session of cardiac rehabilitation to strengthen her heart muscle and normalize heartbeat. She stated that the covid 19 vaccine received might have contributed to the occlusion of left anterior descending artery and heart attack. The patient was treated with clopidogrel bisulfate, metoprolol succinate, aspirin and atorvastatin calcium. The reporter did not have the lot number information, because the packaging was discarded. The patient underwent lab tests and procedures which included on 24Apr2021 cardiac catheterization: showed left anterior descending artery was 100% block; on 26Apr2021 cardio MRI: left anterior descending artery was 100 percent occluded, may undergo stent and balloon placement; on 24Apr2021 echocardiogram: left anterior descending artery was 100 percent occluded; on 22Apr2021 electrocardiogram: abnormal blood flow, artery was not functioning, heart attack; on 24Apr2021 cardiac catheterization: left anterior descending artery was 100 percent occluded. The action taken in response to the events for adalimumab was dose not changed. On 28Apr2021, the artery was not functioning and left anterior descending cardiac artery occlusion resolved. On 30Apr2021, the left arm pain radiating to wrist resolved. On 25Jul2021, the heart attack and heart rate increased resolved. Outcome of other events was unknown.   The reporter's assessment of the causal relationship of the events except for left anterior descending coronary artery occlusion and heart attack with the suspect products was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  Causality for adalimumab: artery occlusion, heart attack, heart rate increased, left arm pain radiating to wrist and electrocardiogram showed abnormal blood flow with adalimumab was no reasonable possibility.    Causality for bnt612b2: left anterior descending coronary artery occlusion and heart attack was a reasonable possibility.  Manufacturer's opinion is that there is no reasonable possibility that the events of artery was not functioning, left anterior descending cardiac artery occlusion, heart attack, increased heart rate, left arm pain radiating to wrist and electrocardiogram showed abnormal blood flow are related to adalimumab.   The lot number for bnt61b2 was not provided and will be requested during follow up.; Sender's Comments: Based on the information available and a close temporal association, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported event of Left anterior descending coronary artery occlusion, Heart attack, Arterial disorder, Heart rate increased, Radiating pain, Disorder circulatory system, Neck pain, Back pain, Pain in arm, Chest tightness, Indigestion and Nausea. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.