Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal, Insomnia, Pruritus, Rash, Tooth disorder
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Also received report from same consumer, in response to Non-HCP letter sent. A 53-year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 26Aug2021 (Lot number: FC3182) at the age of 53 years as dose 2, single and intramuscular, administered in arm left, administration date 05Aug2021 (Lot number: FC3180) as dose 1, single for Covid-19 immunisation. Relevant medical history included: "Anxiety" (unspecified if ongoing); "settle plumbism" (unspecified if ongoing), notes: had a 'settle plumbism' a couple of years ago. Concomitant medication(s) included: HYDROXYZINE; SERTRALINE; ELIQUIS taken for metal poisoning. The following information was reported: RASH (non-serious) with onset Aug2021, outcome "not recovered", described as "Little rash like, they are like a laser size lesions; Had this stuff all down my arms, down the back of my legs, down my back and I still have them"; PRURITUS (non-serious), FEELING ABNORMAL (non-serious) all with onset 26Aug2021, outcome "not recovered" and all described as "Have had this itches, it's miserable and I have been miserable since 26th"; INSOMNIA (non-serious) with onset Aug2021, outcome "not recovered", described as "I have been dealing with it for a long time, specially when your skin is itching you can't sleep, it's been hard"; TOOTH DISORDER (non-serious) with onset Aug2021, outcome "not recovered", described as "One of my implant on my denture popped out of my mouth; Worst experience of my life is having these teeth implants putting in, it's really upsetting". The events "little rash like, they are like a laser size lesions; had this stuff all down my arms, down the back of my legs, down my back and I still have them", "have had this itches, it's miserable and I have been miserable since 26th", "have had this itches, it's miserable and I have been miserable since 26th" were evaluated at the physician office visit and emergency room visit. The events "I have been dealing with it for a long time, specially when your skin is itching you can't sleep, it's been hard" and "one of my implant on my denture popped out of my mouth; worst experience of my life is having these teeth implants putting in, it's really upsetting" were evaluated at the physician office visit. Therapeutic measures were taken as a result of rash, pruritus, feeling abnormal, insomnia, and tooth disorder. Additional Information: COVID-19 is Vaccine a Pfizer product. COVID-19 Vaccine manufacturer: Unspecified. NDC number, UPC number of COVID-19 Vaccine and Expiry Date: Unknown. Is Prednisone a Pfizer product: Unspecified. Prednisone manufacturer was Unspecified. Dates, NDC number, UPC number, Expiry Date of Prednisone: Unknown. Reason for no lot number: of Prednisone: Complaint identified after call completed. Unspecified medication is a Pfizer product: Unspecified. Unspecified medication manufacturer: Unspecified. NDC number, UPC, Expiry Date for Unspecified medication: Unknown. Reason for no lot number: of Unspecified medication: Other: LOT# could not be probed as the medication was unspecified. Dates for Concomitant Products Eliquis: (Start: Unspecified Stop: Unspecified). Additional Information for Concomitant Products Eliquis: Consumer stated, "Well, I take a blood thinner, I take Eliquis, I have had a 'settle plumbism' a couple of years ago and I have been on Eliquis ever since. Additional Context: Consumer stated, "Well, I took the first Pfizer shot on 04Aug2021, 06Aug2021 (further date of vaccination not clarified) and I started to get a little rash like 'they are not like a rash', they are like a laser size lesions, well I don't know which one to call, the dermatologist didn't even know. She have never seen anything like this and what happened was I took the first shot and I noticed these (voice not clear) on me and I went back to my doctor the day before I was going to get my second shot. I want to see if everything is okay, should I (incomplete sentence), I didn't know (incomplete sentence), I wasn't sure if it was the shot or you know, but I didn't want to wait and have to start over and do the first one. So, I want over to hit and did the second one on 26Aug2021. And within 18 hours I had this stuff all down my arms, down the back of my legs, down my back and I still have them. I went to a dermatologist on 16Sep2021 and she said she never seen anything like it and gave me Prednisone and some cream (Unspecified medication) to wipe on it 2 times and so started putting but it didn't work and I ended up, I had an appointment to go on 04Oct2021, I went back to her and she said that she had a family emergency and they want to reschedule on 21Oct2021 and I just couldn't wait that long. I've had this enough, I have had this itches, it's miserable and I have been miserable since 26Aug2021. And I went to urgent care and they gave me something else to try. Now I got another appointment with the dermatologist on Monday to do biopsy. I have never been allergic to anything. This is the first time in my life, I am '54' years old. I am really sorry, I took it, I would say I would have not took it, that's all I could say. I don't blame anybody now who doesn't want to take it, I understand." Name of the vaccine: Pfizer COVID-19 Vaccine. Consumer was informed about the role of Pfizer Drug Safety and requested to probe. Date for second shot: Consumer stated, "Yes I did on 26Aug2021." When probed if it is the first time consumer called Pfizer Drug Safety for the issue, consumer stated, "Yes, I was given this number by the Pharmacist where I had the shot taken and she saw it and she couldn't believe it. So, she just gave me this number to call you, so I am doing so." Consent to follow up: Consumer stated, "Yes, believe me, if I could sue I would because this was happened to me, whatever it did to my 'blood' (further clarification unknown), one of my implant on my denture popped out of my mouth and now I have spent Withheld bucks to get it put back in and they are not even sure if they could be able to put in. So, I have to go and have it put in it and wait 3 months again and believe me it's just been the worst experience of my life is having these teeth implants putting in, it's really upsetting (further not clarified if teeth implants issue was there prior to the vaccination or after getting the COVID-19 Vaccine, hence captured event as per verbatim). I don't have money to begin with and I am not working, I had worked for a while, I am trying to get on disability, it's like I don't need and I have been dealing with it for a long time, months, maybe it doesn't seems like a long time but it is for me specially when your skin is itching you can't sleep and all that, it's been hard that's all I say. If I could I'd sue somebody. You need to be sorry, it's not your fault, I understand you've got nothing to do about it." Country of Incidence: Consumer stated, "The month would be end of 26August2021 it started, I got the shot on 26Aug2021 and it would have been 18 hours so the next day." Product details: LOT#: Consumer stated, "The first shot is FC3180, the second show is FC3182". Expiration date: Consumer stated, "I don't see an expiration date, it says just the date that I had the shot." Anatomical site of vaccination for both shots: Consumer stated, "It will be my left arm.". Other medical condition: Consumer stated, "I take some anti-depressants, pain pills, stuff for anxiety (further clarification unknown)." Event details: Outcome: Consumer stated, "I still have them and I have an appointment on Monday to have a biopsy done which is dermatologist said that's the only way to see what it was, it's just miserable." Treatment: Consumer stated, "Yes, I have gone to a dermatologist and that would be on 16Sep2021, and she gave me Prednisone and like I said some cream and it didn't work. And I wasn't able to see her until 04Oct2021 which I went in but she wasn't, she had to go home or whatever and so I got another appointment on Monday." Time of vaccination for both the shots: Consumer stated, "05Aug2021 would be the first shot and the second one is 26Aug2021. Oh, you want time, I think so it was in the afternoon, I can't remember the exact time, it's good enough I remember the date." When probed if consumer had any other vaccination 4 weeks prior to COVID-19 Vaccine, Consumer stated, "No". Description of Product Complaint: Consumer stated, "I took the first Pfizer shot on 04Aug2021, 06Aug2021 (further date of vaccination not clarified) and I started to get a little rash like, they are like a laser size lesions. I went back to my doctor the day before I was going to get my second shot. I want to see if everything is okay, I wasn't sure if it was the shot or you know, but I didn't want to wait and have to start over and do the first one. So, I want over and did the second one on 26Aug2021. And within 18 hours I had this stuff all down my arms, down the back of my legs, down my back and I still have them. I went to a dermatologist on 16Sep2021 and she said she never seen anything like it and gave me Prednisone and some cream (Unspecified medication) to wipe on it 2 times and so started putting but it didn't work (PC Filed Conservatively), I had an appointment to go on 04Oct2021. I've had this enough, I have had this itches, it's miserable. And I went to urgent care and they gave me something else to try. Now I got another appointment with the dermatologist on Monday to do biopsy. I have never been allergic to anything. This is the first time in my life. I am really sorry, I took it, I would say I would have not took it". Product details: LOT#: Consumer stated, "The first shot is FC3180, the second show is FC3182 (captured in tab)." Expiration date: Consumer stated, "I don't see an expiration date, it says just the date that I had the shot." Treatment: Consumer stated, "Yes, I have gone to a dermatologist and that would be on 16Sep2021, and she gave me Prednisone and like I said some cream and it didn't work. And I wasn't able to see her until 04Oct2021 which I went in but she wasn't, she had to go home or whatever and so I got another appointment on Monday." Vaccination facility type was Pharmacy or Drug Store. Prior to vaccination, patient was not diagnosed with COVID-19. Relevant tests were none. Specific relevant test for thromboembolic events with thrombocytopenia: None. Treatment: Yes; Benadryl. You must have misunderstood. I have been on Eliquis for 2 1/2 years. I don/t feel it caused my condition unless of course, other people who have been on Eliquis had the same horrible reaction I did. I merely mentioned it. If you need further information, let me know. That reaction lasted 3 plus months and left scars. Eliquis- 5 mg 2x's a day. Follow-up attempts are completed. No further information is expected.