Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Blood test, Chest X-ray, Echocardiogram, Electrocardiogram
Clinical narrative: massive heart attack; knee pain; This is a spontaneous report from a contactable consumer (patient). A 43-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6206 and expiration date not provided) via an unspecified route of administration, administered in right arm on 12Mar2021 12:00 as a single dose for COVID-19 immunisation. Medical history included heart attack in 2019, heart disorder (Heart),  Blood cholesterol abnormal (cholesterol), hurt his knee at work prior and torn meniscus. Concomitant medications included ongoing ticagrelor (BRILINTA) for the heart; ongoing atorvastatin for cholesterol and ongoing carvedilol (COREG) for the heart. The patient previously took clopidogrel (PLAVIX) for heart attack. The patient did not receive any other vaccine within 4 weeks prior to the COVID vaccine. No adverse events following prior vaccinations. The patient called about the COVID 19 vaccine. He received his first COVID-19 vaccine on 12Mar2021 and suffered a massive heart attack on the same day. After the event, his cardiologist reviewed video from the heart catherization to open the blockage and the cardiologist indicated that the area that was obstructed with this heart attack had not been obstructed 2 months ago. The cardiologist believed that the COVID 19 vaccine is the culprit in causing the massive heart attack. The cardiologist believed the area of the blockage was too dramatic. The cardiologist encouraged the caller to report the event and the cardiologist will offer his expertise in this matter if needed. The patient also tried to report to his local health department but is waiting on a call back from them. He reported that he had a heart attack in 2019. He was taking Plavix but after this heart attack his cardiologist has changed some of his medications. He reported he believes his medications were changed at his follow up visit with the cardiologist on 23Mar2021. He reported that he had continuous blood work done while in the hospital. They were monitoring his troponin levels. He also had a chest X-Ray, EKG and after the heart attack he had an echocardiogram to monitor the extent of the damage caused by the heart attack. He clarified that he did go to the emergency department on 12Mar2021, the same day he received the Covid 19 vaccine, but for knee pain. He received a pain relief injection of fentanyl that day. He had hurt his knee at work prior. He had previously had an MRI of his knee that showed a torn meniscus. He does not believe his knee pain on 12Mar2021 is related to the Covid 19 vaccine as he had already had an MRI that showed a torn meniscus. He had gone to the emergency department for pain management of his knee. He thought he would be given a lower strength pain medication but received Fentanyl. While the patient was at the emergency room for his knee, he suffered a massive heart attack. The patient clarified that he went to the emergency department because of pre-existing knee pain and while at the emergency department caller suffered a massive heart attack. The patient was hospitalized for massive heart attack from 12Mar2021 to 18Mar2021. The outcome of the event heart attack was recovering while the outcome of the event knee pain was unknown.; Sender's Comments: Based on temporal association, the causal association between BNT162B2 and the massive heart attack cannot be completely excluded. The knee pain was assessed as an intercurrent condition and is unrelated to BNT162B2.  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 RAs, Ethics Committees, and Investigators, as appropriate.