Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Atrial fibrillation, Biopsy skin, Cheyne-Stokes respiration, Dermatitis, Dyspnoea
Clinical narrative: TIA; Cheyne stokes breathing; had 3 moles that responding with fluid-filled which dried up and flaked off; After that PAF, it was the first time again in years/after his TIA he had paroxysmal atrial fibrillation; ID reaction in his moles; air hunger; This is a spontaneous report from a contactable physician (patient). A 64-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), (at the age of 64 years old) via an unspecified route of administration on 07Aug2021 (Batch/Lot number was not reported) as dose 1, single for covid-19 immunisation. Medical history included paroxysmal atrial fibrillation years ago, he has been bedridden for a year; ongoing cancer, last year (2020) he was paranoid and dealing with his cancer recovery; he has diuresed a bunch, and GIA. There were no concomitant medications. The patient previously took aspirin for paroxysmal atrial fibrillation. The patient wanted to know if fluid-filled moles are reported as a side effect with the Pfizer Biontech COVID19 (Comirnaty) vaccine. The patient stated that he had 3 moles that responding with fluid-filled which dried up and flaked off. The third which is the largest among the three actually remains changed. He had a biopsy because he happens to be seeing his oncologist and it was an incomplete biopsy which he will going to have it removed. It occurred before the second vaccine and stated that all three occurred about 10-11 days after and there are two of them that occurred within 2 weeks of the first vaccine (Aug2021). The patient also mentioned that he was hospitalized two weeks after first vaccine for something that is almost undealt but not related since he had a GIA which is most like caused by his pre-existing paroxysmal atrial fibrillation. After that PAF, it was the first time again in years. In addition to that, caller also stated he doesn't think that hypercoagulability was described with the vaccine. Caller is mildly curious to know if people are having embolic events with the vaccine. The patient had an ID reaction on his moles within the week of his 1st Pfizer COVID vaccine (onset date also reported as "30Aug2021") and he went to look and see if this has been reported before and he didn't see anything in the literature about it, but he couldn't convince himself that it isn't from the COVID vaccine. His moles became fluid filled and they scraped it off and now he just has less moles than he had before. He is not concerned about it except one had stuck around and he had to have a shave biopsy for that and then they are going to have to go back and make a bigger incision for it. He wanted to report this, and he wanted someone to reassure him on if this has been reported before. His failure to find the information doesn't mean that it hasn't already been experienced. He was an emergency medicine physician until 3 years ago. When he mentioned this to his oncologist the patient was actually following up on another cancer and then he had just pointed this out regarding the increased mole on his back. Then he had the shave biopsy and now he is going to have the whole thing removed, because why not, on Tuesday. When inquired for when this had developed, the patient stated it was on or about 23Aug2021. He doesn't have his wallet with him to confirm this since he is getting his car charged as he speaks. He says that he had it by then and he thinks that he had his vaccine two weeks before that. He had a TIA on 23Aug2021 and then had noticed a mole on his left upper arm that had gotten to the point where it was fluid filled. He punched on it and said, "hmm where did that come from?" He thought, does he have bed bugs? Then he noticed that he had another in the same area of his body and thought how odd. He then put two and two together and then shortly thereafter he had another mole on his upper back about that same time. He has a picture of it that is from the Monday a week following. He then provided that on 19Aug2021 he was hospitalized because of his TIA then he spent a week in a residential psychiatric unit and took a picture of his back then. He had the 2nd COVID vaccine on the Friday before that. The time frame is in the two weeks following, or 13 days, following the first COVID vaccine or so, he might have been a day late so maybe 12 days (19Aug2021), but following that he had a TIA. The things on his arms had already transpired by then. On the Monday after his second dose, which was a day late so it was 22 days after his 1st dose, he was admitted to the psychiatric hospital. While there, he had a picture taken of the mole without any scale and it was not even a centimeter in diameter, it was more or less round. Then he had a biopsy done 10 days ago or something like that and the results came back and said that it was an incomplete biopsy and that it maybe could have been something else and he is convinced that it was an ID reaction. It means that something in his body reacted with the antibodies and it is not really inflamed, it happens a lot. It is comparable to what happens with poison oak. If you touch it with your hands it can still get everywhere because of the similarity in the skin cells that are reacting to the reaction of the initial inflammation. Other parts of the body can get inflamed even if they were not touched by it. It happens all the time. When inquired for when the patient had his TIA, he mentioned that he had that 2 weeks after on a Thursday (19Aug2021). Since he is on the phone, he can't check these things but yeah at that time he had some reactions. One of the things that he was worried about with being out in public for the first time in a long time with going in to get the COVID vaccine. Then he had the manifestation of having bad luck 10 weeks, clarified to 7 weeks, later. But he is satisfied and that is not the problem. When Inquired for when the patient was admitted and discharged to the psychiatric hospital, he says that on 30Aug2021 is when the picture was taken of his mole. He was admitted to a place the previous Friday and he had his 2nd dose of the COVID vaccine that would have been on 27Aug2021. Two days before 23Aug2021, 21Aug2021, he had the TIA and then two weeks before that he had the 1st dose of the COVID vaccine, 07Aug2021. He stated that he had his doses three weeks apart, well actually 22 days apart because he was in another hospital after the TIA. The patient confirmed that he thinks his 1st dose was on 07Aug2021 and his 2nd dose on 27Aug2021. The patient mentioned that it is non-serious. The only thing that he would say is that it will be a small expansion of time that is going to be spent dealing with this. If there is enough of the issue where Pfizer can say that it is an ID reaction and people don't need to worry about it clinically then maybe they can save the world. The only hassle is that he has less moles now than when he started without doing anything and essentially that is cosmetically beneficial. With his curiously and hopeful reassurance of being told that this is no big thing he figured out it would just be an ID reaction. All he had to do was go through a shave biopsy and get it removed and it is not going to cost much but he thought that it was interesting that it happened around that time. He thinks that the COVID vaccine caused an immune response in his moles, or something similar to that, to the COVID antigen. He thinks that the ID reaction in his moles is completely 100% associated, there is no chance that this would have happened without the COVID vaccine. He, at 64-years-old, has never had his moles do anything other than be moles. Then he gets the COVID vaccine and in less than two weeks he had these things and then at the same time had the TIA. He was aware of two of the moles and then by the three-week mark he noticed the other. He has a picture that was taken 25 days later, and he can send that if Pfizer needs it, and they can also get his path report as well. He thinks that this is almost anecdotal in the sense that he doesn't think that is really mattered. He is a retired physician but this nothing that he has ever experienced. Inquired if the patient felt that the TIA and hospital admission were due to the COVID vaccine and he says that is an interesting question and it hadn't really occurred to him because he already had a couple risk factors for the TIA. He has been bedridden for a year and had paroxysmal atrial fibrillation years ago. He did notice that after his TIA he had paroxysmal atrial fibrillation. When he went into the hospital, it's not really described but there are people that are getting some level of blood clots. But he had other risk factors and had been put on Xarelto and theoretically failed because he had a TIA on that 3 weeks in. But he thinks they are pointing to the paroxysmal atrial fibrillation and addressing that separately. He is going to try to get an ablation to hopefully make him come off of the Xarelto and if there's an increased chance to cloth with the vaccine then maybe it is related but things happens and then you die. And it may kill him in the morning, but he wanted to get the best vaccine and he would recommend it under any circumstances. Sure, the vaccine could have contributed but he doesn't think that anyone's 1st, 2nd or 3rd thinking would have been the vaccine. He knew that he had paroxysmal atrial fibrillation. At first when this happened his first thought was, oh looks like he is having a stroke and then 20 minutes later he was like it really does look like he is having a stroke and by the time he went in and it was detected the next morning they said he had a profound TIA. He was having air hunger and everything and he even had Cheyne stokes breathing. He really put himself at risk there. But he thinks that this is not caused by the vaccine, maybe it contributed, and it can be related but that was already set up to happen and it is not like he can do anything anyways other than if he wanted to know if his coagulation profile is changed and by how much and be anticoagulated. But he wants to go skiing so he is not going to do that, being anticoagulated is a bad idea. The patient clarified that he was put on Xarelto after he had the TIA. He thinks that there is evidence that things happen before but not two weeks before taking a medication. The patient begins sneezing and says, there is the delta variant as we speak. The patient was saying this as a joke, not because he has the delta variant. The patient has no new medical conditions other than the ones already described that he thinks are relevant. He does have a cold right now (at the time of reporting) and of course a cold in the time of COVID maybe could be COVID. He doesn't know. He also has no medication. He was not taking any medications at all the two weeks prior to his vaccine or after his cancer treatment. Most of his medications that were available to him were inappropriate anyways and his ability to do self-care went to the floor. He was alone and had two hearo machines for his medications that he couldn't set up and if he had they weren't the right ones anyways so he went a year without taking any of the medication that he should have taken. He has been off of his Aspirin for a while that was said that people with paroxysmal atrial fibrillation should be on but then someone decided that they shouldn't be on it, so he isn't. Presently, seems like he has no life for his TIA. Maybe that is not completely true, but it seems like it. He has been taken off of his aspirin which was okay, and they had suggested that aspirin expires but he knows that there are few medications that actually expire. The patient asked if the antigen that is in the Pfizer vaccine, the mRNA that causes the antigen, does this produce an immune response or does the mRNA actually create the antibody? Basically, his real question comes down to is it contraindicated to get the Moderna COVID vaccine as well? He thinks that he might want to go back to clinical practice and given the delta variance it is not as good for the immune regarding the Pfizer vaccine. It seems to make sense to get the Moderna vaccine. He has spent the last year paranoid and dealing with his cancer recovery and it's like if he can get more coverage why would he not rather have that than less coverage. This was addressed but indirectly so, in the patient's mind that says that the Pfizer vaccine is absolutely initially the best one for pre-delta but not pretty much for delta. So, he just has the two questions, mainly the one about the contraindication to the Moderna vaccine. The outcome of the event "had 3 moles that responding with fluid-filled which dried up and flaked off" was not recovered while the other events were unknown. Relatedness of drug to event "ID reaction on his moles" was assessed as related.  The lot number for BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events Transient ischaemic attack, Cheyne-Stokes respiration, Melanocytic naevus, and Atrial fibrilla-tion and BNT162B2.  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.