Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Atrial fibrillation, Dyspnoea, Pain in extremity, Swelling, Wheezing
Clinical narrative: Atrial fibrillation; arm is a little sore, swollen; arm is a little sore, swollen; Wheezing; she has a hard time getting 'wind'; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 76-year-old female patient received BNT162b2 (BNT162B2), on 21Sep2021 as dose 3 (booster), single (Lot number: EW0158) at the age of 75 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing); "Sore knee" (unspecified if ongoing); "Sore joint" (unspecified if ongoing); "Migraine" (unspecified if ongoing); "Headache" (unspecified if ongoing); "Blood thinner" (unspecified if ongoing). The patient's family history included: "Bronchitis" (unspecified if ongoing); "Asthma" (unspecified if ongoing). Concomitant medication(s) included: DIGOXIN; METOPROLOL; ELIQUIS taken for thrombosis; ENTRESTO; AMIODARONE; ASPIRIN [ACETYLSALICYLIC ACID]. Vaccination history included: BNT162b2 (DOSE: 1, Single, The first two I had at (Clinic name)and that was just where my doctor is that is in that clinic), administration date: 10Jan2021, when the patient was 75-year-old, for Covid-19 Immunization; BNT162b2 (DOSE: 2, Single,, The first two I had at (Clinic name)and that was just where my doctor is that is in that clinic), administration date: 31Jan2021, when the patient was 75-year-old, for Covid-19 Immunization. The following information was reported: ATRIAL FIBRILLATION (medically significant), outcome "unknown"; PAIN IN EXTREMITY (non-serious), SWELLING (non-serious), outcome "unknown" and all described as "arm is a little sore, swollen"; WHEEZING (non-serious), outcome "unknown"; DYSPNOEA (non-serious), outcome "unknown", described as "she has a hard time getting 'wind'". Therapeutic measures were not taken as a result of atrial fibrillation, pain in extremity, swelling, wheezing, dyspnoea. Clinical Information: (Pfizer). Consumer already received 3 doses of the Pfizer BioNtech covid-19 Vaccine (2 shots of the primary series and 1 booster shot) but was not aware back then that she has A-fib. Consumer is currently taking heart medication Digoxin, Metoprolol, Eliquis, Entresto, Amiodarone, and Aspirin 81 mg. Consumer also has hypertension, has a hard time getting wind / breathing due to bronchitis and asthma (patient also has family history of both bronchitis and asthma). Caller specified that her father has a history of heath health issues and her mother side has also trouble with the heart. Her mother died from a sudden heart attach (52 years old). Consumer mentioned that she got her very last shot (1st booster shot) of the Pfizer BioNTech covid-19 Vaccine on 21Sep2021. Caller didn't know that having trouble getting wind is a symptom of heart failure. Caller didn't have any pain and wheezing when she had bronchitis, Caller also stated that she had no heart issues all these years and "might be going on for a long time" with no chest pain and that her A-fib "popped out" immediately. Caller also mentioned that the first doses of the Pfizer BionTech covid-19 Vaccine was "fine and easy" for her. Caller mentioned that she might not get the 2nd booster together as compared to her husband who already got the 2nd booster of the Pfizer Biontech covid-19 Vaccine, not until 27May2022 when she is able to consult with her cardiologist. Reaction / Event as Reported by the Primary Source for Translation: arm is a little sore, swollen, Atrial fibrillation, Wheezing, she has a hard time getting 'wind'. Outcome of reaction/event at the time of last observation: Unknown. Concomitant Drug(s) Information: Eliquis, Dosage text: 5mg, Twice a day. Amiodarone HCl. Digoxin. Metoprolol, Dosage text: 25mg, Twice a day. Aspirin, Dosage text: 81mg, Once a day. NDC number of COVID-19 Vaccine, UPC number of COVID-19 Vaccine and Expiry Date of COVID-19 Vaccine was Unknown. Patient has hypertension, and she has A-fib (atrial fibrillation). She mentioned that she got the very last dose, which is the first booster shot, last 21Sep. She also mentioned that her arm is a little sore, swollen. She mentioned that her family has a history of Bronchitis and Asthma and she has a hard time getting 'wind' (event captured conservatively) and she didn't know that it was a symptom of heart failure. She also mentioned that on the first 3 doses of the vaccine, she did not know that she has Atrial Fibrillation, so she just found out about it after the first booster shot (atrial fibrillation captured as event conservatively as 'she has Atrial Fibrillation' was diagnosed after the booster shot), and one last information is that she also has wheezing and she briefly mentioned that her dad's side, her father's side has a history of heart health conditions and for her mother's side, her mother suddenly died of heart attack 53 years old. Consumer stated, I just turned 76 two days ago. Age at the time of vaccine administration: Consumer stated, Right, that was September 21st last year that I took my first booster. I was 75 (76 years old at present). That's not the first shot. That was the first booster. Weight: Consumer stated, "My weight is 177 point something. I take it for 178 (pound)." (Consumer was unsure, hence weight not captured in tab). took all Pfizer vaccines and I took them real fast when they were available. The first two I had at, my regular doctor and the third one I had at the Facility. Expiration date: Consumer stated, I don't see anything like that, there are just capital letters. I don't know what that means. No Other prior vaccinations (within 4 weeks). Anatomical site of vaccine administration: Consumer stated, "I think it was my left arm, no it was my right arm, the 1st shot. I don't have the like 2nd shot the 3rd shot was on my right arm. I didn't even feel the shot. That is even unbelievable. I didn't even feel it and I didn't even think I had it until at my home. Vaccination facility details: Consumer stated, "The last, the booster shot was at the Facility. That was the 3rd one. The first two I had at Clinic and that was just where my doctor is that is in that clinic. Consumer stated, "The first shot was 10Jan2021 and the second one 31Jan2021. Other medical conditions: Consumer stated, "No, well I have a sore knee, you know sore joint from an injury but nothing else that I know of. I used to get migraine headache but I don't anymore." Concomitant medications: Consumer stated, "No, just the one listed for A-fib. I was taking a whole bunch of vitamins but my doctor asked me to stop those. I guess so we could figure out the medication that I need now." Name of the concomitant medications: Consumer stated, "I am taking Eliquis. Eliquis I take twice a day, 5 mg two times a day. Eliquis is for hopefully so I don't get blood clot. So I guess it is a blood thinner (indication). I don't know I am not 'accurate' with it. The other one is Entresto, 24 to 26 mg tabs, two times a day. Amiodarone HCL, right now I am finishing up two weeks of 400 mg of that and then starting the 3rd week of it taking 200 mg one time a day. This one I am doing, since two weeks I have taken 28 tablets in two weeks I have taken 800 mg a day 400 mg tablet and then now starting third week on the 200 mg and one time a day so that would be end of it, few days I got three of them. I am taking Digoxin and I am taking one a day. I am trying to find milligrams on here. I don't know where the milligram are here. I would guess 25 but I really don't know, I do not see it. I am taking Metoprolol and that is 25 mg. I started at 50 but my progression went well. So they took me back to 25 mg two times a day. The last one is 81 mg of Aspirin, one time a day." LOT# and expiration date (Eliquis): The manufacturer# is B-M looks like 9SQUIBBUS. I do have another number I can give you on the Eliquis. I don't know what it is S/N #and there is a GTIN#. LOT# and expiration date (Entresto): Consumer stated, the date it was filled was 15Mar2022. I have an Rx#, do you want that. I do have discard by 15Mar2023, 15Mar2023. So discard by 15Mar2023. I am looking for a LOT#. I am going to give you something I don't know what it is. LOT# (Amiodarone): Consumer stated, "This one, it says discard after 13Apr2023. I do have number. LOT#(Digoxin): Consumer stated, "It says, it has got the refill, 12 refills, it is one among they give me by 15Apr2023. I am looking for expiration date. Use before 04, I think that is a 15. There is a midline between it could be 15 or 16, 2023. It is for Digoxin." LOT# (Metoprolol): Consumer stated, 25 mg tab. Three refills until 11Mar2023, discard by 15Mar2023 (confirmed as 15Mar2023) and then the Aspirin, it is a little dose. This is just over the counter. I guess I got a number here P125793 and then it is the date Jun2023." Lab tests: Consumer stated, "No, they have taken a lot of blood out of me through this process but in the last couple of weeks, no ma'am." No Treatment in response to adverse event. Consumer stated, "I guess that is it. I am just, I want to get my 2nd booster. So the gentleman who was on the phone before said I have to talk with my doctor because I don't know where I am in A-fib. They changed my meds 3 times and they are trying to regulate it and I don't know what I have to have, if I have to be back in good sinus rhythm or not to get the vaccine.  No follow-up attempts are possible. No further information is expected.