Received Sep 10, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | 1 | — | — |
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | 1 | — | — |
a nodule real close to the heart; aneurism; This is a spontaneous report received from a Consumer or other non HCP. A 77-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Primary Immunization Series Completed.), for Covid-19 immunisation. The following information was reported: NODULE (hospitalization, medically significant), outcome "unknown", described as "a nodule real close to the heart"; ANEURYSM (hospitalization), outcome "unknown", described as "aneurism". The patient was hospitalized for nodule, aneurysm (discharge date: Aug2025). Therapeutic measures were taken as a result of nodule. Clinical Course: Patient reported that "I had a nodule real close to the heart so they took the whole thing out. So I been through the mill. Does this medicine has a lot of side effect? I mean like knock you out and stuff?". "Getting old is no fun. And I used to have a lot of fun." Later (Name withheld) stated, "They wanted me to take it because I have one lung gone, you know that's why they wanted me to take it". After being informed how the program works, (Name withheld) stated, "Yeah, 'cause I'm getting really scared, you know I had, I had a 104 fever, then I took some Tylenol and it went down, then it went back up, then it went back down, then it went back up, it went back down, And they gave me this cough medicine that makes it so nothing comes up and you know I only got you know a lung and a half. And I am too cute to die. I had all four COVID shots, I had all four, like I have before, either 4 or 5, I took every one of them. And then I got it anyway." When asked to confirm he took the COVID shots, I have had all my COVID shots, I didn't get the new one now. When I get better I guess I'll take that one. All these years I never got it, all of a sudden. I went to sleep, I woke up, I mean I was freezing, I was freezing so much I couldn't even move, and I went to get up, my legs were like jelly. I was afraid to go ahead and buy it, and then I was afraid to go ahead and take it, buy it and take it and maybe you drop dead. I've had an aneurism, then I had a thing in my leg, then I had the thing, the lung, piece of part lung taken out. I just got out of the hospital about 3, 4 weeks ago. I might've caught in the hospital and laid dormant until I got better and kicked me good". The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.