Received Sep 23, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | 1 | — | — |
She has some kind of unknown bleeding disorder; nose bleeds; nose bleeds/bleeding disorder; IgM number really goes up; This is a spontaneous report received from a Consumer or other non HCP from medical information team. A 94-year-old female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), in Nov2024 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Waldenstrom macroglobulinemia" (unspecified if ongoing); "blood pressure abnormal" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Aspirin, reaction(s): "bleeding disorder", notes: since about 20-25+ years ago; Advil, reaction(s): "bleeding disorder", notes: since about 20-25+ years ago. Vaccination history included: Bnt162b2, for covid-19 immunisation. The following information was reported: HAEMORRHAGIC DISORDER (medically significant), outcome "unknown", described as "She has some kind of unknown bleeding disorder"; EPISTAXIS (medically significant), outcome "unknown", described as "nose bleeds"; CONDITION AGGRAVATED (medically significant), outcome "unknown", described as "nose bleeds/bleeding disorder"; BLOOD IMMUNOGLOBULIN M INCREASED (non-serious), outcome "unknown", described as "IgM number really goes up". The events "she has some kind of unknown bleeding disorder", "nose bleeds" and "nose bleeds/bleeding disorder" required physician office visit. Therapeutic measures were taken as a result of haemorrhagic disorder, epistaxis, condition aggravated. Clinical Course: She has some kind of unknown bleeding disorder. She passed all tests for bleeding disorder and is not on blood thinner but they are calling it unknown bleeding disorder. Does it have same action as taking Aspirin or Advil. Those are medications that seem to bring on bloody noses for her. She had no problem with previous vaccines. Patient has a question about the most recent Pfizer Covid shot. he read something about medical conditions such as bleeding disorder or blood thinners. Her last Pfizer Covid 19 vaccine was in Nov2024. Reported "I have a preexisting condition, before receiving the COVID vaccines, called Waldenstrom macroglobulinemia, a rare lymphoma, but not on treatment because I don't have any symptoms and on a watch and wait. I also have a bleeding disorder or reaction to aspirin and Advil or NSAIDs (also preexisting condition to COVID vaccines) since about 20-25 plus years ago, that if i take more than a couple of them, I would have nose bleeds. I am not on a blood thinner. The last bad one was in Jan or Feb2025, every couple of weeks but one day, it was like a terrible hemorrhaging nose bleed that lasted 24 hours. It started with blood just coming down to the floor and I had a towel and holding my nostril for hours and bought nose clips and finally got it under control. Eventually it stopped. I went to a throat doctor to cauterize it. It happened again after the cauterization but eventually it stopped. I don't have that high of a blood pressure but on high blood pressure medication and perhaps it is related to that. My platelets are fine and I clot well if I have an injury or if I get a scratch or cut. My doctor says I have a blood disorder of unknown cause. My immune system is not that good because of this Waldenstroms disease and since my IgMs go up with my disease, we have to watch that. When I get a vaccine, the IgM number really goes up and then it goes down within months. This is what happened after the last Pfizer Covid 19 vaccine in Nov2024, my IgM numbers went up after the vaccine and then the IgM numbers went down over time. " The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.
Medical History/Concurrent Conditions: Blood pressure abnormal; Waldenstrom's macroglobulinaemia