Age: 72.0
Sex: U
Vaccine: COVID19
Symptoms: Anaemia, Blood urine present, Culture urine, Full blood count, Renal function test
Clinical narrative: anemia; urine bleeding; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 72-year-old patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 6 (booster), single (Batch/Lot number: unknown) at the age of 72 years for covid-19 immunisation; cilgavimab, tixagevimab (EVUSHELD), from 21Jun2022 (Batch/Lot number: unknown) to 21Jun2022. The patient's relevant medical history included: "ESRD", start date: 10Feb1996, stop date: 20Sep1998, notes: CAPD; "CAPD" (unspecified if ongoing); "Renal Tx", start date: 20Sep1998 (ongoing), notes: Still working; "HFPEF" (ongoing), notes: Aortic valve replacement 2011; "Aortic Valve replacement 2011", start date: 2011 (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose 1, Time: 11: 15, Anatomical site of injection: Arm, Route of administration: Intramuscular, Batch/lot no: EL9261), administration date: 29Jan2021, for Covid-19 Immunization; BNT162b2 (Dose 2, Time: 17: 30, Anatomical site of injection: Arm, Route of administration: Intramuscular, Batch/lot no: WTEM9809), administration date: 18Feb2021, for Covid-19 immunization; BNT162b2 (Dose 3, Time:  15:00, Anatomical site of injection: Arm, Route of administration: Intramuscular, Batch/lot no: FC3181), administration date: 16Aug2021, for Covid-19 immunization; tdap (Manufacturer : NA, Batch/lot no: , Route : intramuscular, Anatomical site of injection: Arm), administration date: 14Jan2021, for Immunization; Bnt162b2 (DOSE 4 (BOOSTER), SINGLE), for Covid-19 immunization; Bnt162b2 (DOSE 5 (BOOSTER), SINGLE), for Covid-19 immunization. The following information was reported: BLOOD URINE PRESENT (non-serious) with onset 26Jun2022, outcome "recovered" (27Jun2022), described as "urine bleeding"; ANAEMIA (non-serious), outcome "unknown", described as "anemia". Relevant laboratory tests and procedures are available in the appropriate section. The action taken for cilgavimab, tixagevimab was unknown. Therapeutic measures were taken as a result of blood urine present. Additional information: The patient felt like as if no one was hearing him/her. Started to fill out the forms sent and finally realized it was all about some of the Pfizer covid vaccine. Patient had no reaction to any of 3 vaccines and 2 boosters and 1 bivalent booster. Stated that urine bleeding issues were after Evusheld and the monoclonal antibodies received. Had bleeding 5 days after receiving Evusheld and 3 weeks after the monoclonal antibodies. Patient had stressed out that it was not related to the vaccines. Patient was very pleased to see that the vaccines and Evusheld and monoclonol antibodies worked. It was reported that although the episode after the Bmab was more than two weeks, patient felt like it's still relevant - just a delayed reaction. In each case, the bleeding lasted no more than 48 hours. Patient was put on Cipro for the first in anticipation of a UTI. As for the second, there was no treatment. In both, there was no UTI, and the cultures were negative. The only other tests were CBC and renal panel. Other than some anemia and the color of the urine, results were within normal range. The patient has no family history.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.