Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Biopsy, Dermatitis, Melanocytic naevus, Nasopharyngitis, Pathology test
Clinical narrative: ID reaction on his moles; ID reaction on his moles; cold/ sneezing; This is a spontaneous report from a contactable physician (patient himself). A 64-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 27Aug2021 (Batch/Lot number was not reported) at the age of 64 years, as dose 2, single for COVID-19 immunisation. Medical history included atrial fibrillation years ago (has been bedridden for a year), cancer, spent the last year paranoid and dealing with his cancer recovery, and 'diuresed a bunch.' There were no concomitant medications. He was not taking any medications at all the two weeks prior to his vaccine or after his cancer treatment. The patient previously took aspirin E.C. for paroxysmal atrial fibrillation, and rivaroxaban (XARELTO) for transient ischemic attack (TIA), both on unspecified dates. He received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 07Aug2021 at the age of 64 years, as dose 1 for COVID-19 immunization and experienced transient ischemic attack (TIA), he had a GIA which is most like caused by his pre-existing paroxysmal atrial fibrillation, had 3 moles that responding with fluid-filled which dried up and flaked off, ID reaction in his moles, and Cheyenne stokes breathing. On 30Aug2021, the patient experienced ID reaction on his moles. 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 of been something else and he was convinced that it was an ID reaction. Patient sated "it means that something in his body reacted with the antibodies and it was not really inflamed, it happened a lot. It was 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." Patient was admitted and discharged to the psychiatric hospital on 30Aug2021 which was when the picture was taken of his mole. Patient reported that it was non-serious. The only hassle was that he has less moles now than when he started without doing anything and essentially that is cosmetically beneficial. Patient stated "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." The patient began sneezing and stated that he did have a cold. He thinks that the ID reaction in his moles was completely 100% associated, there was 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. He was aware of two of the moles and then by the three week mark he noticed the other. He had 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 was almost anecdotal in the sense that he doesn't think that really mattered. He was a retired physician but this was nothing that he had ever experienced. The patient underwent biopsy: unknown results (incomplete biopsy), and pathology test: unknown results, both on unspecified date. The outcome of the events was unknown.  Primary Source Reporter Assessment of Relatedness of drug to event ID reaction on his moles was Related (Method of assessment: Global Introspection).  The lot number for the vaccine BNT162B2 was not provided and will be requested during follow-up.; Sender's Comments: Based on available information and a possible contributory role of suspect product BNT162B2 to the development of events dermatitis and melanocytic naevus cannot be totally 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 RAs, Ethics Committees, and Investigators, as appropriate.