Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Emphysema, Myocarditis, Peripheral swelling
Clinical narrative: myocarditis; Blood pressure it was 240 over 180; Leg swollen to my knees; heart was swollen; Mild emphysema; Shortness of breath with exertion; This is a spontaneous report received from a contactable reporter(s) (Nurse).  A 66-year-old male patient received bnt162b2 (BNT162B2), on 18Feb2021 as dose 2, single (Lot number: EL9267) at the age of 65 years, in arm for covid-19 immunisation. The patient's relevant medical history included: "had quit smoking" (unspecified if ongoing), notes: so he had quit smoking about 3 months before the event. There were no concomitant medications. Vaccination history included: bnt162b2 (DOSE 1, SINGLE, LOT#: EL3249, Expiration date: Reporter stated, "It is not on the paper. It does not have an expiration date."), administration date: 28Jan2021, when the patient was 65-year-old, for COVID-19 Immunization. The following information was reported: DYSPNOEA (non-serious) with onset Jun2021, outcome "unknown", described as "Shortness of breath with exertion"; BLOOD PRESSURE INCREASED (hospitalization) with onset Oct2021, outcome "unknown", described as "Blood pressure it was 240 over 180"; PERIPHERAL SWELLING (non-serious) with onset Oct2021, outcome "unknown", described as "Leg swollen to my knees"; EMPHYSEMA (non-serious) with onset Oct2021, outcome "unknown", described as "Mild emphysema"; CARDIAC DISORDER (non-serious) with onset Oct2021, outcome "unknown", described as "heart was swollen"; MYOCARDITIS (hospitalization, medically significant) with onset Oct2021, outcome "unknown". The event "myocarditis" required physician office visit. The patient underwent the following laboratory tests and procedures: Blood pressure increased: 240, notes: over 180; Catheterisation cardiac: Unknown results; Computerised tomogram: Unknown results. Therapeutic measures were taken as a result of myocarditis, blood pressure increased, dyspnoea, peripheral swelling, cardiac disorder, emphysema. Clinical course: Reporter stated, "I am calling to report a possible reaction that my husband had to his COVID Vaccine. Currently they did not spell out an adverse reaction like I thought they did at the hospital at the time of event. I want to make sure that it was recorded now. I am reporting an adverse reaction that my husband had to his COVID Vaccine. Yes, he was hospitalized. So, at the time that he was hospitalized we were not aware that the COVID Vaccine was linked to myocarditis and my husband had an event in Oct2021 after he had received two COVID Vaccines. He did not have anything on it prior to these event. He woke up and he started having some shortness of breath. A few months before the event no chest pain but he thought it was because of his smoking and he quit smoking and so he had quit smoking about 3 months before the event and in the middle of the night he woke me up and said I just get up to go to the bathroom and my left leg swollen to my knees.  So, I took his blood pressure it was 240 over 180 and so I took couple of Aspirin and took him to the car and take him to the hospital. When we go to the hospital they ran cath test and one of them was Heart Cath they said that his coronary arteries were big and wide open, his valves were perfect but his heart was swollen. So, they kept him for a week and took 11 liters of fluid of him. He had an ejection fraction of 10%. They sent him home with LifeVest and the cardiologist who gave the Heart Cath said, he had no chest pain he said no none. He was not sick at all prior to this event he said no I never missed a day at work and then I never had any illnesses. I started getting a little bit more short of breath and sprain, I had smoked for years about 5 years ago, I switched from cigarettes to Cigars. He have had a CAT scan of his lungs to evaluate his lungs and they said he had mild emphysema and that is when he had switched from cigarettes to cigars. When he was in hospital, they gave some Lasix and 'diuretic' and started him on a bunch of other medications for his heart failure. My husband legs was swollen and he had no infection prior month. Months prior, he was healthy with no infections or anything. He was completely healthy. He had gone to work the night before or the day before and woke up at 3'O clock in the morning and had swollen legs. I do have to tell you one more thing that because we were not aware at that time that the COVID-19 was causing the myocarditis, he did not consider the COVID-19 as a culprit possible and so he did receive the another COVID Vaccine in December. He took the COVID Vaccine on 03Dec2021and it was again the COVID-19 Pfizer Vaccine that he had 3 doses of that. The first dose was 28Jan2021. The second dose was 28Feb2021 and the third dose was 03Dec21 and when we had the Heart Cath the doctor said I say this is probably cause by bed rest when you sit at all and we said no he has been healthy for last six months and he said I don't, I expect him to get for recovery is what he said. When his coronary arteries being perfect and his valves being perfect he said there is nothing wrong in his heart. He started feeling out better but shortness of breath in about Jun2021. His age is 68 years." Third Dose LOT#: FJ1620. Expiration date: Reporter stated, "On that stuff it does shows the expiration date. 31May2022 (31May2022). He was on no medications and have no diagnosis of any disease. He has no lab work done in last two weeks. In Jun2021 and it was very mild shortness of breath. It was Shortness of breath with exertion. He has some very mild shortness of breath with exertion and it is like it does not have any shortness of breath anymore. Yes, He is on Entresto, dose is 97/103, he takes one tablet twice a day. He is on Metoprolol Succinate ER 50, twice a day. He is on 'Xeljanz' (Not clarified) 10 milligrams once a day and Spironolactone 25 milligrams, once a day and he is on Lasix 10 milligrams, one tablet PRN (As needed). It does not say on his vaccine card where they gave the shot. All of them were in arm and I do not know which one of it. Previous medication. He was on no medication prior to the event. He got the Flu Vaccine on 20Oct2022." The patient took no vaccine on same date with Pfizer COVID Vaccine.; Sender's Comments: Based on the available information and the known product safety profile, a causal relationship between the reported event Myocarditis and suspect product cannot be excluded. Based on the available information, a causal relationship between the reported event Blood pressure increased and suspect product 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.