Sex: M
Vaccine: COVID19
Symptoms: Inflammation, Investigation, Pain in extremity, Peripheral swelling, Rash
Clinical narrative: unable to walk; pain and swelling of the legs; open wound on both legs; pain and swelling of the legs; ESR Blood/Result: Inflammation worsened; rash appeared all over both legs; swelling at times; Anti-CCP Ab, IgG/IgA: Positive Rheumatoid factor; SV Vasculitis; The initial case was missing the following minimum criteria: AE. Upon receipt of follow-up information on 08Jul2022, this case now contains all required information to be considered valid.  This is a spontaneous report received from contactable reporter(s) (Pharmacist), Program ID.  A male patient received BNT162b2 (BNT162B2), on 26Oct2021 as dose 3 (booster), single (Lot number: FF2589) intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Cholesterol" (unspecified if ongoing). Concomitant medication(s) included: ROSUVASTATIN oral taken for blood cholesterol, stop date: Apr2022; CLOPIDOGREL oral, stop date: Apr2022. Vaccination history included: BNT162b2 (Dose: 1st, Date: 24Feb2021, Anatomical site of injection: LA, Route of administration: Intramuscular, Batch/Lot number: EN6205), administration date: 24Feb2021, for COVID-19 Immunization; BNT162b2 (Dose 2nd, Date: 17Mar2021, Anatomical site of injection: LA, Route of administration: Intramuscular, Batch/Lot number: EN6204), administration date: 17Mar2021, for COVID-19 Immunization, reaction(s): "red purpura rash started to appear on lower parts of legs - not itching or painful at all". The following information was reported: VASCULITIS (disability, medically significant) with onset 06Apr2022, outcome "recovering", described as "SV Vasculitis"; RHEUMATOID FACTOR POSITIVE (non-serious) with onset 23Apr2022, outcome "unknown", described as "Anti-CCP Ab, IgG/IgA: Positive Rheumatoid factor"; RASH (medically significant) with onset 09May2022, outcome "unknown", described as "rash appeared all over both legs"; SWELLING (medically significant) with onset 09May2022, outcome "unknown", described as "swelling at times"; INFLAMMATION (non-serious) with onset 06Jun2022, outcome "not recovered", described as "ESR Blood/Result: Inflammation worsened"; WOUND (non-serious) with onset 17Jun2022, outcome "unknown", described as "open wound on both legs"; PAIN IN EXTREMITY (non-serious), PERIPHERAL SWELLING (non-serious) all with onset 17Jun2022, outcome "unknown" and all described as "pain and swelling of the legs"; GAIT INABILITY (non-serious) with onset 17Jun2022, outcome "unknown", described as "unable to walk". The event "sv vasculitis" required physician office visit. The patient underwent the following laboratory tests and procedures: Anti-cyclic citrullinated peptide antibody: (23Apr2022) Positive, notes: Rheumatoid factor; Biopsy: (29Mar2022) Unknown results, notes: performed biopsy on 3 locations of legs; (06Apr2022) small vessel vasculitis; Blood test: (Jan2022) Unknown results, notes: did not find anything related to the immune system but she suspected Vasculitis; (16Jun2022) Unknown results; Chest X-ray: (10May2022) Normal; Dermatopathology: (29Mar2022) SM Vessel Vasculatis, notes: Skin Blister; Red blood cell sedimentation rate: (06Jun2022) inflammation woresened; SARS-CoV-2 test: (10May2022) Negative; Urine analysis: (23Apr2022) Normal; X-ray: (16Jun2022) Unknown results. Therapeutic measures were taken as a result of vasculitis, rash, swelling, gait inability, pain in extremity, peripheral swelling.  Clinical course: On 08Jul2022, the reporter was reported that at around end of Jun2021. red purpura rash started to appear on lower parts of legs. not itching or painful at all. Jan2022, the family doctor performed a variety of blood testing and did not find anything related to the immune system but she suspected Vasculitis and referred to a dermatologist. 11Mar2022, checked by a dermatologist and decided to do a biopsy. 29Mar2022, performed biopsy on 3 locations of legs and started on Prednisone 10mg per day. 06Apr2022, the dermatologist diagnosed it as small vessel vasculitis based on the biopsy results and referred to the Rheumatologist. 23Apr2022, checked by HCP (Blood test, chest x-ray, and prescribed to prednisone 60mg per day). 09May2022, follow up by the rheumatologist, rash appeared all over both legs and started swelling at times. The rheumatologist ordered 3 days solu-medrol infusion. 16May to 16Jun2022 while traveling, visited rheumatologist and dermatologist there and was prescribed with prograf 3 mg per day, cephalexin 750mg per day, ultracet 2 times a day, and mupirocin topical ointment. started tapering down Prednisone 60mg. Also, more blood testing, X-rays were performed. 17Jun, HCP ordered rituximab infusion along with blood testing. (by this time, was not able to walk or stand up for even a very short time due to the pain and swelling of the legs and open wound on both legs) HCP ordered Gabapentin 300 mg up to 3 caps a day. 27Jun, 1 st infusion (Ruxience 1000mg). 12Jul, 2nd infusion. Prior Vaccinations: None. Patient's Medical History: None (as reported).  Follow-up (08Jul2022): This is a spontaneous follow up report from a contactable pharmacist. This pharmacist reported for the patient in response to Non-HCP letter [sent to consumer] via follow-up letter which included that:  Updated information included: Primary reporter address updated and updated to be HCP, Patient address added, Cholesterol added as a RMH, Previous two doses added as a historical vaccine, New laboratory test results for Dermatopathology, Anti-CCP Ab, Urine analysis, complete, Chest X-ray, covid-19, ESR Blood, Blood test, X-ray performed, Vaccine information and Vaccine facility information added, Rash both legs, Swelling, Unable to walk, Pain in leg, Open wound, Inflammation, Rheumatoid factor positive, Swelling of legs added as a new event.  No follow-up attempts are needed. No further information is expected.