Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Full blood count, Transplant dysfunction
Clinical narrative: graft wasn't working and clotted; had the 4th vaccine; This is a spontaneous report received from contactable reporter(s) (Physician). The reporter is the patient.  A 58 year-old male patient received bnt162b2 (BNT162B2), administered in deltoid right, administration date 02Mar2022 (Lot number: FK9895) at the age of 58 years as dose 4, single for covid-19 immunisation, immunodeficiency. Relevant medical history included: "Verbatim: autoimmune neuromuscular disorder" (unspecified if ongoing), notes: Verbatim: autoimmune neuromuscular disorder; "Verbatim: MGUS" (unspecified if ongoing), notes: Verbatim: MGUS; "Verbatim: B12 deficiency" (unspecified if ongoing), notes: Verbatim: B12 deficiency; "Iron deficiency" (unspecified if ongoing), notes: Verbatim: Iron deficiency; "Crohn's disease" (unspecified if ongoing), notes: Verbatim: Crohn''s; "Verbatim: GERD" (unspecified if ongoing), notes: Verbatim: GERD; "Verbatim: Gastroparesis" (unspecified if ongoing), notes: Verbatim: Gastroparesis; "Verbatim: Raynauds" (unspecified if ongoing), notes: Verbatim: Raynauds; "Verbatim: DJD" (unspecified if ongoing), notes: Verbatim: DJD; "mild coronary disease." (unspecified if ongoing), notes: verbatim:mild coronary disease. Concomitant medication(s) included: CELLCEPT [MYCOPHENOLATE MOFETIL HYDROCHLORIDE]; PREDNISONE; BABY ASPIRIN; CYMBALTA; LIPITOR, start date: 24Feb2022; VITAMIN D [COLECALCIFEROL]. Vaccination history included: Bnt162b2 (Dose 1, single), for COVID-19 Immunization; Bnt162b2 (Dose 2, single), for COVID-19 Immunization; Bnt162b2 (Dose 3, single), for COVID-19 Immunization. The following information was reported: TRANSPLANT DYSFUNCTION (medically significant) with onset 06Mar2022, outcome "not recovered", described as "graft wasn't working and clotted"; EXTRA DOSE ADMINISTERED (non-serious) with onset 02Mar2022, outcome "unknown", described as "had the 4th vaccine". The patient underwent the following laboratory tests and procedures: angiogram: graft clotted, notes: In November the caller's graft clotted and they did an angiogram in his left upper arm where his graft is; blood calcium: minimally normal; blood fibrinogen: fibrinogen drops, notes: Usually your fibrinogen drops after the procedure so you're at risk for bleeding; cardiac stress test: normal; full blood count: platelet was normal, notes: The caller had a CBC done before his plasmapheresis and his platelet was normal and nothing was significantly abnormal.  Clinical course: The caller is immunocompromised and had the 4th vaccine on Wednesday. The caller gets plasmapheresis for a neuromuscular problem. The caller had the plasmapheresis on Wednesday and afterwards he got his 4th dose of the vaccine. Then Sunday the caller's graft wasn't working and it clotted. The caller doesn't know if it had to do with the vaccine but if it did then there is a clotting issue with the vaccine. The caller's Calcium score was minimally normal and his nuclear stress test was normal so he has mild coronary disease. The caller had a CBC done before his plasmapheresis and his platelet was normal and nothing was significantly abnormal. They don't check clotting factors or anything. Usually your fibrinogen drops after the procedure so you're at risk for bleeding. In Nov the caller's graft clotted and they did an angiogram in his left upper arm where his graft is. The caller's axillary vein at the anastomosis was all scarred down. They had to balloon it and stent it and it was fine until this time. This time after the plasmapheresis it didn't bleed excessively long like the last time.  No follow up attempts are possible. No further information is expected.; Sender's Comments: Based on the current limited available information and the drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events transplant dysfunction and extra dose administered cannot be excluded.   The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.