Age: 37.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Autoimmune disorder, Headache, SARS-CoV-2 test, Thoracic outlet syndrome, Vasodilatation
Clinical narrative: Autoimmune disease; headache; prominent veins in right arm; prominent veins in right arm; suspected to have thoracic outlet syndrome; This is a spontaneous report received from a contactable reporter(s) (Physician).  A 37 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 26Dec2020 (Batch/Lot number: unknown) at the age of 37 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "pre-diabetes" (unspecified if ongoing); "borderline hyperlipidemia" (unspecified if ongoing), notes: borderline hyperlipidemia; "mild macular degeneration" (unspecified if ongoing), notes: mild macular degeneration. Concomitant medication(s) included: LO LOESTRIN FE; ZYRTEC [CETIRIZINE HYDROCHLORIDE]; TYLENOL. The following information was reported: AUTOIMMUNE DISORDER (disability, medically significant) with onset 05Jan2021, outcome "not recovered", described as "Autoimmune disease"; HEADACHE (disability) with onset 05Jan2021, outcome "not recovered", described as "headache"; VEIN DISORDER (disability), VASODILATATION (disability) all with onset 05Jan2021, outcome "not recovered" and all described as "prominent veins in right arm"; THORACIC OUTLET SYNDROME (disability) with onset 05Jan2021, outcome "not recovered", described as "suspected to have thoracic outlet syndrome". The events "autoimmune disease", "headache", "prominent veins in right arm", "prominent veins in right arm" and "suspected to have thoracic outlet syndrome" were evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (09Jan2021) negative, notes: Nasal Swab; (21Jan2021) negative, notes: Nasal Swab. Therapeutic measures were taken as a result of autoimmune disorder, headache, vein disorder, vasodilatation, thoracic outlet syndrome.  Clinical course: Facility type vaccine: Hospital. No other vaccine administered in four weeks. AE treatment: Prednisone, hydroxychloroquine. Patient did not have covid prior vaccination. 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.  The lot number for bnt162b2 was not provided and will be requested during follow up.; 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 autoimmune disease, headache, prominent veins in right arm, prominent veins in right arm and thoracic outlet syndrome cannot be excluded.  The case will be reassessed if additional information becomes available. 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.