Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Atrial fibrillation, Herpes zoster
Clinical narrative: Afib; shingles; This is a spontaneous report received from a Nurse.  An 84-year-old female patient received BNT162b2 (BNT162B2), on 13May2022 as dose 4 (booster), single (Lot number: FK9894) at the age of 84 years for covid-19 immunisation. The patient's relevant medical history included: "Cholesterol" (unspecified if ongoing). Concomitant medication(s) included: SIMVASTATIN taken for blood cholesterol; VITAMIN D [COLECALCIFEROL] taken for bone disorder; OMEPRAZOLE taken for abdominal discomfort; LORAZEPAM taken for anxiety; LOSARTAN taken for blood pressure abnormal; LEXAPRO taken for anxiety. The patient also took other concomitant therapy daily dose of MULTIVITAMIN. Vaccination history included: BNT162b2 (Dose: 01), administration date: 20Jan2021, when the patient was 82-year-old, for COVID-19 Immunization; BNT162b2 (Dose: 02), administration date: 10Feb2021, when the patient was 83-year-old, for COVID-19 Immunization; BNT162b2 (Dose: 03, Lot number: FE3590), administration date: 15Oct2021, when the patient was 83-year-old, for COVID-19 Immunization. The following information was reported: ATRIAL FIBRILLATION (medically significant) with onset 19May2022, outcome "unknown", described as "Afib"; HERPES ZOSTER (non-serious) with onset 2022, outcome "unknown", described as "shingles". Therapeutic measures were taken as a result of atrial fibrillation.  Clinical information: Consumer stated, "Don't talk too fast. I have got hearing aids and I have hearing problem. Consumer stated, I had the Pfizer Vaccine and going back and I have a Afib and going back over my records it shows that every time I get a vaccine of the COVID Vaccine then several days later I go into Afib, atrial fibrillation and the last time in Nov I went into heart failure. Asking as do you want the dates of this stuff or what, what do you want to know. Consumer stated, I was a nurse (Later clarified as Retired Nurse), I am 85, I was a nurse 25 years ago. When probed which COVID shot was got her into atrial fibrillation: Consumer stated, "When I went into atrial fib that was in May, I have done it twice. You want the most recent one or the one that, okay 13May2022. COVID booster number 4, it was my 4th injection. Other medication and other medical conditions: Consumer stated, "I am on Simvastatin, Calcium Vit B, 600 milligram, two times a day it was for my bones. I take Lorazepam or Ativan (Not clarified if taking brand or the generic) as needed, I have not hardly used that but as needed I have it. Omeprazole, capsule 20 milligram as needed and I rarely use that. Aspirin (Treatment) 81 milligrams, 3 times a week for the atrial fib, blood thinner. Then my newest drugs I am on because of all this that happened to me was Losartan 25 milligrams daily and Lexapro 10 mgs daily. Losartan was for my blood pressure and Lexapro was for my nerves, anxiety and Lasix (Treatment) I had to take with, that was 20 milligrams and that was for what I went into heart failure so, like retained all this water in my feet, body but I do not take it right now, I am okay not retaining all that much. Omeprazole(Indication): For stomach. Lorazepam (Indication): Consumer stated, When I have anxiety that's 0.5 milligram. Other previous vaccination with Pfizer COVID vaccine, consumer stated, "Yes, my first one was 20Jan2021 then I had second one on 10Feb2021, then I had third one 15Oct2021 and the LOT# on that was FE3590, then I had a fourth one on 13May2022 that LOT# was FK9894, then I got one in 02Dec2022 and that was look like a GL0446, then I next one on 08Nov2023 and that's the one I do not, I did not get a number on. It's probably on website and you know how they do but 08Nov. Consumer further stated, "One other question I am thinking about, did you want like in Dec2023 when I, it didn't goes back. My COVID booster number 9 in May2022 and then I got shingles. On 02Dec2022, I have the vaccine and that's when I felt so bad and I got some tremors and so then I got the regular flu vaccine in Oct. So anyways you got the main part that because I feel the COVID vaccine put me into Afib back in 2022 because 13May I got COVID booster number 4 and 19May, I had 6 seconds of Afib that was revealed on my paper. I have a heart pacemaker so that was 6 days later after the COVID booster I got Atrial fib and then I took the regular flu vaccine and I got Atrial fib and had the 'cardioversion' and then I take COVID vaccine and I go into heart failure. No, they can call me if they want more information. Consumer stated, no I don't. I got that at (name withheld) and they put them on website, so I don't have a proper copy of that but that flu vaccine was also at (name withheld). Call was disconnected from the call handler's side after taking the permission from consumer as consumer was unable to disconnect the call from there side. No other vaccine administered on the same date with Pfizer Vaccine, consume stated.; Sender's Comments: Based on the information provided, a causal relationship between the suspected drug and the reported event Atrial fibrillation 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