Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiac failure, Fluid retention
Clinical narrative: Heart failure; I filled up with water from heart failure/Retained all this water in my feet, body; This is a spontaneous report received from a Nurse.  An 85-year-old female patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 08Nov2023 as dose 1, single (Batch/Lot number: unknown) at the age of 85 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Cholesterol" (unspecified if ongoing), notes: Relevant Medical History and Concurrent Conditions: Cholesterol; "blood pressure" (unspecified if ongoing); "Anxiety" (unspecified if ongoing); "For stomach" (unspecified if ongoing), notes: For stomach; "my bones" (unspecified if ongoing), notes: my bones; "I have hearing problem" (ongoing), notes: I have got hearing aids and I have hearing problem; "a heart pacemaker " (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. Vaccination history included: BNT162b2 (DOSE 1, SINGLE), administration date: 20Jan2021, when the patient was 82-year-old, for COVID-19 immunization; BNT162b2 (DOSE 2, SINGLE), administration date: 10Feb2021, when the patient was 83-year-old, for COVID-19 immunization; BNT162b2 (DOSE 3 (BOOSTER), SINGLE, Lot#FE3590), administration date: 15Oct2021, when the patient was 83-year-old, for COVID-19 immunization; BNT162b2 (DOSE 4 (BOOSTER), SINGLE, Lot# FK9894), administration date: 13May2022, when the patient was 84-year-old, for COVID-19 immunization, reaction(s): "Atrial fibrillation", "Shingles"; BNT162b2, BNT162b2 omi ba.4-5 (DOSE 5 (BOOSTER), SINGLE, Lot# GL0446), administration date: 02Dec2022, when the patient was 84-year-old, for COVID-19 immunization, reaction(s): "felt so bad", "Tremor"; Flu vaccine (I took the regular flu vaccine and I got Atrial fib.), for Immunization, reaction(s): "I got Atrial fib". The following information was reported: FLUID RETENTION (non-serious) with onset 2023, outcome "unknown", described as "I filled up with water from heart failure/Retained all this water in my feet, body"; CARDIAC FAILURE (medically significant) with onset 13Nov2023, outcome "unknown", described as "Heart failure".  Clinical information: It was reported that, "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. Do you want the dates of this stuff or what? What do you want to know?". When paraphrased the concern: Consumer stated, "Yes, Nov2023." 08Nov2023 is when I have the vaccine injection." It was an injection in the left upper arm." 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 its 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 is Losartan 25 milligrams daily and Lexapro 10 mgs daily. Losartan is for my blood pressure and Lexapro is 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." Date of Heart failure: Consumer stated, 13Nov2023. When asked if taking Lasix as treatment, consumer stated, "No, Lasix is new. I just start that one. I filled up with water from heart failure. I was not taking Lasix before that." When clarified indication of Aspirin as atrial fibrillation, consumer stated, "Yes." Other vaccine administered on the same date with Pfizer Vaccine, consume stated, "No." 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." When clarify the last one which she took on 08Nov2023, do not not have LOT#: Consumer stated, "Correct." Pfizer COVID vaccine name taken on 08Nov2023, consumer stated, "No, that's the one I don't have LOT number on. That was COVID-19 vaccine injection in the left upper arm." 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. 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." Flu vaccine manufacturer, LOT#, Expiration date, 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.   The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.; Sender's Comments: Based on the available information, the known product safety profile and implied temporal association, a causal relationship between the reported event Heart failure and suspect product BNT162b2 omi xbb.1.5 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.