Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Blood cholesterol, Coronary artery occlusion, Dizziness, Electrocardiogram
Clinical narrative: Coronary artery occlusion; get's weak easily/ weakness; dizziness; Heart attack; This is a solicited report from non-contactable consumer (patient) based on the information received by Pfizer. (Mfr. Control No.: 21K-163-3889347 -00).  A 66-years-old female received second dose of bnt162b2 (PFIZER-BIONTEC COVID-19 VACCINE, Solution for injection, Lot Number and expiry date were unknown) via intramuscularly on 03Mar2021 (at age of 66-years-old) as a single dose for covid-19 immunisation and adalimumab (HUMIRA, Solution for injection in pre-filled pen) via subcutaneous route at 40mg/ 0.4ml (daily dose: 1, Citrate free: 40 mg, 1 in 2 week) for moderate to severe chronic plaque, psoriasis, psoriatic arthritis, ongoing since Jan2019. Medical history included heart disease, high blood pressure, slightly elevated cholesterol level from 2005, supplement, cartilage disease, thyroid disease, anxiety, tobacco use, one pack of cigarettes (from 1966 to 2016), recurrent difficulty in sleeping since 1971, alcohol use from 1971, one glass of wine a glass of bourbon from 1972), recurrent joint pain from 2005 and rheumatoid arthritis. Concomitant medications included acetylsalicylic acid (ASPIRIN) and clopidogrel both for heart disease; metoprolol and lisinopril for high blood pressure; atorvastatin for cholesterol; clobetasol via topical route, methotrexate, ibuprofen and omeprazole for an unspecified indication; folic acid and colecalciferol (VITAMIN D3) both as supplement; glucosamine for cartilage disease; levothyroxine for thyroid disease and naproxen for anxiety. Patient had previously received first dose of vaccine (lot number and expiration date were unknown) via intramuscularly on 17Feb2021, and on same day experienced light headed/ dizziness and recovered on 19Feb2021. On 28Apr2021, patient had heart attack and get's weak easily/ weakness. On 29Apr2021, patient had Coronary artery occlusion. On 28Apr2021, the patient was hospitalized for three days due to heart attack. On 29Apr2021 angioplasty procedure was performed and stent was laced that her artery was 99 percent blocked. She also stated that her heart muscle did not show any damage. She was monitored her electrocardiogram after the procedure and was given blood thinners, blood pressure medication and medication for cholesterol. She was scheduled for a follow up with her cardiologist on 26May2021. She was also advised do cardiac rehabilitation for 12 weeks. The alternate etiology as per the reporter for the event slightly elevated cholesterol level was weight. The alternate etiology as per the reporter for the event light headed and dizziness was COVID-19 vaccination. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Blood cholesterol test was performed in Apr2021 and result was 130. The reporter's causality for the events of cardiac artery blocked and get's weak easily was not provided. The reporter's causality for the event(s) of heart attack and light headed/dizziness with adalimumab (HUMIRA) 40mg/0.4ml was no reasonable possibility. The opinion was that there was no reasonable possibility that the events of cardiac artery blocked, heart attack, get's weak easily and light headed/dizziness are related to adalimumab (HUMIRA) 40mg/0.4ml. The action taken in response to the events for adalimumab (HUMIRA) was unknown. The outcome for event weakness was resolving and for light headed/ dizziness was resolved on 19Feb2021, coronary artery occlusion and heart attack was resolved on 30Apr2021.  Causality for Covid-19 Vaccine  For Coronary artery occlusion  Causality as per reporter (Drug/Vaccine): Not assessable For heart attack Causality as per reporter (Drug/Vaccine): Not Related For weakness Causality as per reporter (Drug/Vaccine): Not Related For dizziness  Causality as per reporter (Drug/Vaccine): Probable  No follow-up attempts are possible, information about lot/batch number cannot be obtained. No further information is expected.