Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Acute myocardial infarction, Axillary pain, Chest pain, Electrocardiogram, Fibrin D dimer
Clinical narrative: tachycardia; Left sided chest pain and arm pit pain; Left sided chest pain and arm pit pain; aches and soreness on the left side; Non ST segment elevation myocardial infarction; This is a spontaneous report from a contactable nurse via a Pfizer-sponsored program Support. A 56-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 22Apr2021 (at the age of 56-year-old; lot number: EW0175; expiry date: 31Aug2021) as DOSE 1, 0.3 ML, SINGLE for COVID-19 immunisation. Medical history included coronary artery disease, myocarditis, obesity, hyperlipidemia, smoker, depression, GERD. History of all previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available) were none. Prior Vaccinations (within 4 weeks) was unknown. Events following prior vaccinations and family medical history relevant to events were none. There were no concomitant medications. Patient received the first dose on 22Apr2021, has not received the second dose yet. In Apr2021, the patient experienced non-ST segment elevation myocardial infarction. The clinical course was reported as follows: the reporting nurse noted from patient's chart stating that patient had non-ST segment elevation with myocardial infarction, which cardiology said may have been from the vaccine, and patient was referred to his physician to decide whether or not to get the 2nd dose. The reporting nurse went to speak with the patient to clarify what happened. Clarified that 4 days after receiving the 1st dose of the vaccine (on 26Apr2021), the patient started having left sided chest pain and left sided arm pit pain, as well as aches and soreness on the left side. He went to the ER on 28Apr2021, and had multiple tests done. He then went to the cardiologist and asked if this occurred from the vaccine. Clarified that the cardiologist put him on medication for his heart and said that he didn't think it was directly related to the vaccine, but suggested that the patient wait more than 6 weeks to get the 2nd dose. Events required a visit to emergency room and physician office. Lab data included testing done in the ER on 28Apr2021: EKG was normal, tachycardia; x-ray was normal, no evidence of pulmonary embolism; D-Dimer was elevated to 1.440. Treatment received for events. Outcome of events was unknown.; Sender's Comments: Based on the available information in the case, the causal association between the events, acute myocardial infarction, chest pain, axillary pain, pain and the suspect drug BNT162B2 cannot be excluded. 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.