Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Anaemia, Arthralgia, Atrioventricular block, Atrioventricular block first degree, Cerebral venous sinus thrombosis
Clinical narrative: right shoulder pain; inflammatory polyarthritis; suspected palindromic rheumatism; pulsatile tinnitus; left cerebral venous sinus narrowing with dural AV fistula; left cerebral venous sinus narrowing with dural AV fistula; developed anemia; pernio; first degree heart block; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 37 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 23Jan2021 (Lot number: EL3247) at the age of 37 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Prediabetes" (unspecified if ongoing); "borderline hyperlipidemia" (unspecified if ongoing); "mild macular degeneration" (unspecified if ongoing). Concomitant medication(s) included: LO LOESTRIN FE; ZYRTEC [CETIRIZINE HYDROCHLORIDE]; TYLENOL. Vaccination history included: Bnt162b2 (Dose Number: 1, prev dose product=COVID 19, prev dose brand=Pfizer, prev dose brand unknown=False, prev dose lot number=EL0140, prev dose lot unknown=False, prev dose administrator route=Intramuscular, prev dose administration date=26Dec2020 , prev dose dose number=1 , prev dose vaccine location=Left arm), administration date: 26Dec2020, when the patient was 36 years old, for COVID-19 immunization, reaction(s): "headache", "prominent veins in right arm". No other vaccine in four weeks. No COVID prior vaccination. COVID tested post vaccination. No known allergies. The following information was reported: ARTHRALGIA (disability) with onset 2021, outcome "not recovered", described as "right shoulder pain"; POLYARTHRITIS (disability, medically significant) with onset 2021, outcome "not recovered", described as "inflammatory polyarthritis"; PALINDROMIC RHEUMATISM (disability, medically significant) with onset 2021, outcome "not recovered", described as "suspected palindromic rheumatism"; TINNITUS (disability) with onset 2021, outcome "not recovered", described as "pulsatile tinnitus"; CEREBRAL VENOUS SINUS THROMBOSIS (disability, medically significant), DURAL ARTERIOVENOUS FISTULA (disability, medically significant) all with onset 2021, outcome "not recovered" and all described as "left cerebral venous sinus narrowing with dural AV fistula"; ANAEMIA (disability) with onset 2021, outcome "not recovered", described as "developed anemia"; CHILLBLAINS (disability) with onset 2021, outcome "not recovered", described as "pernio"; ATRIOVENTRICULAR BLOCK FIRST DEGREE (disability) with onset 2021, outcome "not recovered", described as "first degree heart block". The events "right shoulder pain", "inflammatory polyarthritis", "suspected palindromic rheumatism", "pulsatile tinnitus", "left cerebral venous sinus narrowing with dural av fistula", "left cerebral venous sinus narrowing with dural av fistula", "developed anemia", "pernio" and "first degree heart block" were evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: anaemia: (unspecified date) anaemia; atrioventricular block: (unspecified date) first degree heart block, notes: first degree heart block; investigation: (unspecified date) sle, notes: labwork was consistent with new-onset SLE; magnetic resonance imaging: (unspecified date) dural av fistula, notes: MRI of brain showed left cerebral venous sinus narrowing with dural AV fistula; sars-cov-2 antibody test: (22Aug2021) negative, notes: Blood test; sars-cov-2 test: (01Sep2021) negative, notes: Blood test; (09Jan2021) negative, notes: Nasal Swab; (21Jan2021) negative, notes: Nasal Swab; (13Sep2021) negative, notes: Nasal Swab; (28Sep2021) negative, notes: Nasal Swab; (07Oct2021) negative, notes: Nasal Swab; (07Oct2021) negative, notes: Nasal Swab; (23Nov2021) negative, notes: Nasal Swab; (30Nov2021) negative, notes: Nasal Swab. Therapeutic measures were taken as a result of arthralgia, polyarthritis, palindromic rheumatism, tinnitus, cerebral venous sinus thrombosis, dural arteriovenous fistula, anaemia, chillblains, atrioventricular block first degree. Patient was treated with Prednisone, hydroxychloroquine. Clinical course: Autoimmune disease: had headache, then prominent veins in right arm after 1st dose, suspected to have thoracic outlet syndrome. After 2nd dose, right shoulder pain then inflammatory polyarthritis, suspected palindromic rheumatism. Also pulsatile tinnitus, MRI of brain showed left cerebral venous sinus narrowing with dural AV fistula. Later also developed anemia, pernio and first degree heart block, labwork was consistent with new-onset SLE.; Sender's Comments: Based on possible temporal association the causal role of BNT162B2 Vaccine cannot be excluded for reported events. Case will be reviewed further on receipt of FU information  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