Age: 68.0
Sex: U
Vaccine: COVID19
Symptoms: Blood pressure increased, Skin papilloma, Vaccination site reaction
Clinical narrative: I have a little wrap at the site where; I get the vaccine is like little wrap comes and goes; I had to wrap up my arm like I just had a shot; on my arm it was a little wart comes up; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68-year-old patient received BNT162b2 (BNT162B2), on 08Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown, Expiration Date: Jan2022) at the age of 68 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 21Feb2021 as dose 1, single (Lot number: 028L20A, Expiration Date: Jul2021), on 19Mar2021 as dose 2, single (Lot number: 045A21A, Expiration Date: Aug2021) and on 08Mar2022 as dose 4 (booster), single (Lot number: 046L21A) for covid-19 immunisation. The patient's relevant medical history included: "Heart transplant" (unspecified if ongoing), notes: Heart transplant; "blood pressure levels up" (unspecified if ongoing), notes: Blood pressureTaking Lisinopril Other medication make bloodpressure levelsup So taking Lisinopril. Concomitant medication(s) included: RAPAMUNE; NEORAL taken for heart transplant; PREDNISONE taken for heart transplant; LISINOPRIL taken for blood pressure increased. The following information was reported: VACCINATION SITE REACTION (non-serious), outcome "unknown", described as "I have a little wrap at the site where; I get the vaccine is like little wrap comes and goes; I had to wrap up my arm like I just had a shot"; SKIN PAPILLOMA (non-serious), outcome "unknown", described as "on my arm it was a little wart comes up". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information:Additional Context: Consumer stated, "I went to the website reported after seven months I got this, I got the vaccine and noticed that on my arm it was a little wart comes up and with comes up on the site of vaccine. I said several months. (Pfizer COVID-19 vaccine) Yes. I have a little wrap at the site where I was took, I get the vaccine is like little wrap comes and goes." In response to reporting, consumer stated, "Yes.Consumer was informed about Pfizer Drug Safety. In response to further probing, consumer stated, "Let me get my documents. Hold on. Okay, I have gotten. I got."When probed for the mailing address, consumer stated, "(Mailing address)." (No paraphrased completely. Hence, not captured in the Age: '68' Years. When probed for LOT# and Expiration date, consumer stated, "4889 I guess it is. I don't know what it is. It doesn't say LOT#. No. I can give you the information that I have here number. I don't know it says P8020. I don't know. I don't know it says LOT#, that's what it says. 8020, yes." When probed for prior vaccination, consumer stated, "Yes. Moderna. No. This I took, this was the third vaccine. Moderna, I have had three vaccines. I had a Moderna then I had another Moderna and I had a Pfizer and I had a another Moderna. I have four vaccines, booster and vaccine right now."Vaccination details: First vaccine: Moderna Date of Vaccination: 21Feb2021 LOT#: 028L20A (Captured as provided) Expiration date: Jul2021 (Jul2021) When probed for the NDC# and UPC#, consumer stated, "No."Second vaccine: Moderna (Unspecified Vaccine) Date of vaccination: Consumer stated, "19Mar, I think why it is 19Mar2021, yes." LOT#: 045A21A Expiration date: Aug2021 (Aug2021) When probed for the NDC# and UPC#: Consumer stated, "No."Date for Pfizer vaccination: Consumer stated, " This was the 08Nov2021 (08Nov2021), yes." Fourth Vaccine: Moderna Date of Vaccination: 08Mar2022 (08Mar2022) LOT#: 046L21A Expiration date: 03. I don't see the expiration date. No, not even the expiration date on here."When probed for other medical conditions, consumer stated, "No, I am not suffering. I have a medical condition but I am not suffering. I had a heart transplant." When probed for concomitant medication, consumer stated, "Yes, I do. Sirolimus (Hence, captured Sirolimus in tablet), the brand name is Rapamune. Because for rejection." When probed for treatment, consumer stated, "I don't understand what you saying. No ma'am I am not taking. I am calling to report it. I just, I know it's happening and I just woke up and my arm, I had to wrap up my arm like I just had a shot, it's just like its little 'incompent', it goes and comes."Further consumer stated, "I will give you the other medication I take too, I take more than that. I take Neoral, for the same reason I have had heart transplant (Further clarifications Unknown). I take Neoral but I take Prednisone also. I take Lisinopril, well that's the cause because I take other medication, other medication make my blood pressure levels up (Hence blood pressure captured as indication and other medical history). So I have taking Lisinopril. I take supplements." (Further clarification unknown) Indication for Prednisone: Consumer stated, "Because of my heart transplant for rejection. All the mediation I have taken for rejection" (Further clarifications unknown) Consumer was provided with the report reference number as QYK24GIV.In response to report reference#, consumer stated, "Just say it QY, what. That's it. Okay, QYK24GIV. Okay." Further consumer stated, "Yes, so do I need, I need to call Moderna now, Don't I because I call, do I need to call Moderna." Consumer was informed that Safety report has been filed and was informed to connect with the manufacturer for further details.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.