Received Sep 22, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | 1 | — | — |
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | 1 | — | — |
felt palpitations; This is a spontaneous report received from a Consumer or other non HCP from medical information team. A 69-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in Nov2023 as dose 1, single (Batch/Lot number: unknown) at the age of 67 years for covid-19 immunisation. The patient's relevant medical history included: "Arrhythmia" (ongoing), notes: Benign; "Heart palpitations" (ongoing), notes: Benign. The patient's concomitant medications were not reported. Vaccination history included: Moderna (DOSE 1, SINGLE), for Covid-19 Immunization, reaction(s): "Covid-19", "Covid-19"; Moderna (DOSE 2, SINGLE), for Covid-19 Immunization, reaction(s): "Covid-19", "Covid-19", "Heart palpitations". The following information was reported: PALPITATIONS (non-serious), outcome "recovered", described as "felt palpitations". Relevant laboratory tests and procedures are available in the appropriate section. Additional information: Per transferring agent question did a new Covid (formulation) has a new formulation than the last seasons booster shot. Per caller initially when covid started, Patient (he) took a Moderna, and he took a covid booster, He thought and then he and what happened was he thought might be with booster or maybe a second Moderna shot, He had bad palpitations he had history of benign arrythmia, that has been confirmed by my cardiologist for quite a while, so it comes and goes every 4 year or whatever, but that was right after so he was advised to consider changing per caller because Moderna seems to be stronger he knew it had slightly better efficacy. Per caller he switched to Pfizer (covid 19 vaccine) and maybe be for 5 minutes that night he felt palpitations but nothing anywhere what he had with the other one (covid vaccine) so he was actually happy with that so now they were actually coming out with the new (Pfizer) vaccine, for the latest variant had they changed the formulation much other than adding the new variant? How much had it changed will it be similar to the booster that he took? Per caller he had palpitations he get them occasionally since he was 34 (years old). Per caller it was possible he just got diagnosed with having crystals in the ear and someone had made reference that there was a vagus nerve that went form the stem of the head down through the heart and intestines and he had have implication there. He took MRIs there was a concern that he might had "white spots" so that had to do possibly with vagus nerve but it had been 35 years and he still play sports and he was fine. Per caller so he probably had some impact to the vagus nerve, he didn't know if that something that might be triggered by a covid vaccine, the last time he took a booster which was about Nov2023. He was going to take it again last year but unfortunately ended up coming down with Covid and covid wasn't bad for him last year but it was time to take a new on (covid vaccine). Per caller Moderna was stronger had a higher no covid rate. Also negative side to that was stronger and he had a trouble with it in his case. In regard to report of palpitations after Pfizer covid 19 vaccine caller sated: He remember he was sitting at the table he was sitting now and just though feeling them a little bit and they disappeared. Transferring agent stated, "He did had patient on the line, calling regarding Pfizer COVID-19 Vaccine (COVID-19 Booster Vaccine) and reporting adverse event. He reported having, he said that he initially took Moderna (Name of the vaccine not clarified hence, suspect captured as unspecified vaccine) and he had bad palpitations after the Moderna vaccination then was switched to Pfizer and reported that he felt palpitations for maybe 5 minutes and the question he had to medical information just in case if that comes up if the formulation the 2025-2026 formulation was different than the previous vaccination. So, his understanding was he was referring to the previous booster for Pfizer COVID-19 Vaccine (COVID-19 Booster Vaccine). He just asked the question, you know, in order to determine if it was safe for him to get the current formula. He forgot to ask, he was 69 years old." When paraphrased the concern, transferring agent stated, "Yes so bad palpitations with Moderna, palpitations with Pfizer. He just want to make sure that was what they had noted. He was so sorry the connection was not good for a moment. He said for maybe 5 minutes." Consumer stated, "He was just speaking to. Quick history, He had heart palpitations beginning for 30 years. He got them, they come and they go, he did not know, if it was an effect to the vagus nerve, the back of the head, who knows but the brain scan were shown no issue so, when he took the first vaccine, he took, it was a Moderna and he had no problem with taking it and then they went back to the second one, he thought and soon after he had probably the worst palpitations he had had in a long time that lasted about a week and he had a monitor on and his cardiologist came back and said, it was just, he just get them, he know, it was no issue, it was benign, did not say anything about pericarditis or myocarditis or anything like that. He said but he went, he knew and he still wanted him to avoid COVID so he still took, let him try Pfizer instead so he took the Pfizer booster in Nov2023, he only say that because he was going to take last year in July or August, he did not and he ended up coming down with COVID. It was not bad but so after he took that Nov2023 the Pfizer booster, he was fine. There was only maybe a five minutes situation at night where he was sitting at the kitchen table and he felt some palpitation but it was nothing anything compared to the after he took the Moderna one. So, he did tell his cardiologist that, he said again and he had had a cardio, he did every day there, his cardio work out but nothing was showing up significant. So, he just wanted to check with Pfizer if they would change the formulation drastically and the answer he got was no except for dealing with the latest Variants and he thought the protein that the government wanted to make sure is added in. So, Redacted said, they would like them, he did like them to just give that report to one of their folks who was associated with keeping stats so, if they had any questions feel free, he would answer any questions they had." When probed the vaccine name, consumer stated, "they mean initially, the first two, he think, he took was Moderna." When paraphrased the concern, consumer stated, "Second one, yeah, he mean, he was really hoping, he did not feel them but he have to admit that he thought he felt them, they knew, he meant like, he usually feel so he could feel the uneasiness for a couple of minutes and then it disappeared. It was more in, he would say, yeah, they could say July, he would say July or August but it was definitely end of the summer." When probed again age when patient experienced bad palpitation after take Pfizer booster shot, consumer stated, "That was with Moderna and that was probably I would say sometime in 2022, let just say Jul2022. he don't have the exact date." When probed again age when patient got covid again, consumer stated, "he was 69." (Clarified as 69 years) (Captured as provided). Consumer stated, "What was the need of that because what he was trying to do was said, they did not want to get covid. So, instead of taking the Moderna shot again, why didn't he tried something else like Pfizer and the only one else he knew of was Pfizer. He was not sure if the word Pfizer came out of his mouth he just said, if they had that reaction with the Moderna shot, maybe they should try something different. But he still recommended him to take a shot. His response was in reaction to his reaction to the Moderna shot." Consumer was informed since Pfizer has a legal and ethical responsibility to report every problem to FDA and we maintain an accurate safety profile of the drug, which ultimately helps others using this product. They contacted doctor Redacted because he recommended Pfizer and that wouldn't be the correct story and that's why he got to watch what you going to do with data. He was data person so he no what data what people can do with data. He didn't know what they were going to do with it but certainly and hopeful he didn't tell him next time he see him that they were contacted by the national 'disease' center that he receive, that he prescribed sometime, so hopefully they were doing the right things to make sure they were getting what he provided." When informed the consumer that it's up to them if they want to continue the report, consumer stated, "Let me assure this what do you do with it in terms of the document you report back to the doctor?" Consumer was informed that if they would allow Pfizer then only Pfizer will do a follow-up with the doctor, consumer stated, "No, he didn't because He was going to be as confused as he was as to why was he being called about prescribing Pfizer. He was concerned with what your end of it is getting was going to translate to the doctor, so he did not want that to happen. It would be the wrong story, the proper story is I got severe palpitations after he took the Moderna booster, he diagnosed if he had anything the answer was no and the bottom line was they said they had a choice either, you know do not take anything and risk getting covid or you move to the next one. So, if you are not going to tell if that's not what the national institute of health is going to be told he did not want that pass on. It's no value then, because they both will be focusing on the wrong thing. The thing was, he had bad Palpitations after Moderna booster and my question initially was, did you change the formulation the Pfizer booster much at all and since you did not, he would probably call his doctor up and say look do you advise he took their Pfizer shot again he would probably say yes because he had minimal to no palpitations afterwards with Pfizer. The story was going to go to the National Institute of Health was going to be, that sounds to him that he was going to be told, he recommended the Pfizer's vaccine. It's like, here was the bottom line you know what is worse than a lie telling a half-truth because the half-truth is perfect for the person telling it, but they are not telling the other side of the story. You were misled by the half-truth and you are from a lie. So, If he didn't had the confidence that the data was going to be treated correctly. He think it was going to be treated as a half-truth and for that reason he didn't want to report to them. So, he guess they could end the call he think they would be the one It would be wrong story If he do understand that's so." 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: Linked Report(s) : US-PFIZER INC-202500182555 same patient/drug, different event with time gap;
Arrhythmia (Benign); Palpitations (Benign)
Test Name: Brain scan; Result Unstructured Data: Test Result:No issue