Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Biopsy, Corrective lens user, Gait disturbance, Hypoacusis, Infusion
Clinical narrative: blood clot; kidney levels are very low, in chronic kidney levels; she had a problem with her hearing, eyesight and even with walking/Lost hearing; she had a problem with her hearing, eyesight and even with walking; she had a problem with her hearing, eyesight and even with walking; Has affected respiratory; in ugly pain; feet swelling; spotting on legs was very red, ugly spotting shiny; vasculitis has affected retina; She was diagnosed with Vasculitis disease; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP), Program ID:. The reporter is the patient.  A 58-year-old female patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 08Sep2022 about noon as dose 5 (booster), single (Lot number: GH9694) at the age of 57 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Diabetic" (unspecified if ongoing), notes: For 6 years, very well controlled, even up to now; "Wagner's disease" (unspecified if ongoing), notes: caller stated is all a combination of the vasculitis. There were no concomitant medications. Vaccination history included: bnt162b2 (Dose 1, Anatomical location: Got in right arm, Lot number: EM9810, Time: About noon), administration date: 06Feb2021, when the patient was 56-year-old, for COVID-19 immunization, reaction(s): "hurtful for a couple of days on right arm"; bnt162b2 (Dose 2, Lot number: EM9810, expiration 30Jun2021, Anatomical location: Got in left arm, Time: About noon), administration date: 27Feb2021, when the patient was 56-year-old, for COVID-19 immunization; bnt162b2 (Dose 3, Lot number: EN6202, expiration date: 30Jun2021, Anatomical location: Got in left arm, Time: About noon), administration date: 11Nov2021, when the patient was 57-year-old, for COVID-19 immunization; bnt162b2 (Dose 4,, lot number: FJ9943, Anatomical location: Got in left arm, Time: About noon), administration date: 01Apr2022, when the patient was 57-year-old, for COVID-19 immunization. The following information was reported: VASCULITIS (non-serious) with onset May2023, outcome "not recovered", described as "She was diagnosed with Vasculitis disease"; THROMBOSIS (medically significant), outcome "unknown", described as "blood clot"; RENAL IMPAIRMENT (medically significant), outcome "unknown", described as "kidney levels are very low, in chronic kidney levels"; DEAFNESS UNILATERAL (medically significant), outcome "unknown", described as "she had a problem with her hearing, eyesight and even with walking/Lost hearing"; VISUAL IMPAIRMENT (non-serious), GAIT DISTURBANCE (non-serious), outcome "unknown" and all described as "she had a problem with her hearing, eyesight and even with walking"; RESPIRATORY DISORDER (non-serious), outcome "unknown", described as "Has affected respiratory"; PAIN (non-serious), outcome "unknown", described as "in ugly pain"; PERIPHERAL SWELLING (non-serious), outcome "unknown", described as "feet swelling"; RASH MACULAR (non-serious), outcome "unknown", described as "spotting on legs was very red, ugly spotting shiny"; RETINAL DISORDER (non-serious), outcome "unknown", described as "vasculitis has affected retina". Specifically, calling about the Pfizer COVID booster shot, took all COVID shots and boosters through Pfizer. Caller was diagnosed with vasculitis, has done everything, looked into family history, nobody has this. Going to doctors and specialists, going through treatment and infusions already. Vasculitis was reported as worsened. Vasculitis: Has affected respiratory, asking caller if caller has been in mines or exposed, caller has not, only thing exposed to is the Pfizer injections. Diagnosed with vasculitis in May2023, that was actual diagnosis then. Started with testing and everything between Feb2023, Mar2023 and Apr2023, trying to figure out what was going on. Lost hearing, eyesight, couldn't hardly see, couldn't walk, couldn't get up, in ugly pain, feet swelling, spotting on legs was very red, ugly spotting shiny, thought was having a blood clot or something in feet, that's what got caller to go to emergency room, clarified and confirmed was not admitted into hospital. Continues to follow up with physician. Caller was an over the road truck driver, woke up one morning and couldn't hear from one ear. Stated vasculitis is very chronic, had to do infusions, already going to do a 2nd dosage of infusions, supposed to be every 6 months, caller's kidney levels are very low, in chronic kidney levels, but needs the infusions, so going to do another round starting next week of infusions. Only been 4 months since 1st infusion, and already has to do another one. Patient has a kidney consultation specialist, has an eye doctor for eyes, now has to go to a retina doctor because sees vasculitis has affected retina. Caller had to put eyeglasses on to provide information from vaccination card. Diabetic: Diabetic for 6 years, very well controlled, even up to now. Took care of diabetes, has grandkids, thinking was taking care of diabetes because didn't want grandkids to see caller without a limb or injecting herself. A1C is great, and now with vasculitis caller has done all of this to take care of herself, now look at vasculitis. Stated vasculitis is not even curable, nothing to do, just try to control it, but there is no cure for vasculitis. The events "blood clot", "she had a problem with her hearing, eyesight and even with walking/lost hearing", "has affected respiratory", "in ugly pain", "feet swelling" and "spotting on legs was very red, ugly spotting shiny" required emergency room visit. The events "kidney levels are very low, in chronic kidney levels", "she had a problem with her hearing, eyesight and even with walking", "she was diagnosed with vasculitis disease" and "vasculitis has affected retina" required physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: Biopsy: very active in caller's system. Therapeutic measures were taken as a result of renal impairment, vasculitis.  Follow-up (10Nov2023): This is a spontaneous follow-up report received from a contactable consumer (patient), updated Information includes: Reporter Information, Patient Information, Other Relevant History, Vaccine Facility Information and New event coded as "Thrombosis", "Kidney function abnormal", "Respiratory disorder", "Pain", "Swelling of feet", "Red spotty rash" and "Retinal disorder" and clinical course added.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300370043 Same patient, same drug/different dose, different AE.;