Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Aphthous ulcer, Behcet's syndrome, COVID-19, Eye inflammation, SARS-CoV-2 test
Clinical narrative: Vein occlusion; May had behcet's syndrome; Inflammatory condition in eyes/right eye; Canker sore in mouth; COVID-19; COVID-19; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 22K-163-4256878-00.  A 59 year-old female patient (unknown if pregnant) received bnt162b2 (BNT162B2), intramuscular, administration date 31Mar2021 (Batch/Lot number: unknown) at the age of 59 years as dose 1, single, intramuscular, administration date 21Apr2021 (Batch/Lot number: unknown) as dose 2, single and intramuscular, administration date 17Sep2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Batch/Lot number: unknown) and subcutaneous, administration date Jan2021 (Batch/Lot number: unknown) for uveitis. Relevant medical history included: "covid-19", start date: Nov2020 (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant) with onset 2021, outcome "unknown", COVID-19 (medically significant) with onset 2021, outcome "recovering" and all described as "COVID-19"; VASCULAR OCCLUSION (medically significant), outcome "recovering", described as "Vein occlusion"; BEHCET'S SYNDROME (medically significant), outcome "unknown", described as "May had behcet's syndrome"; EYE INFLAMMATION (non-serious), outcome "recovering", described as "Inflammatory condition in eyes/right eye"; APHTHOUS ULCER (non-serious), outcome "recovered with sequelae", described as "Canker sore in mouth". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (Nov2020) positive; (Jan2021) positive. The action taken for adalimumab was unknown.  Additional Information: The female patient with events of vein occlusion and non-serious inflammatory condition in eyes, right eye, canker sore in mouth, may had behcets syndrome and covid with humira (adalimumab). On unknown dates, she experienced vein occlusion, inflammatory condition in eyes, right eye, canker sore in mouth and may had behcets syndrome. In Nov2020, she experienced covid. In Jan2021, she experienced covid. Pfizer biontech covid-19 vaccine (tozinameran) was also considered suspect. She had some headache. In Nov2020 and Jan2021, she had covid positive diagnosis and paused humira therapy during these times and then took injection about nine days late around 19Jan2021, then she had monoclonal antibody infusion received. In Sep2021, she paused humira therapy to receive covid pfizer vaccination booster shot. She had chronic canker sore in mouth. She had vein occlusion, blood flow to retina stopped and created inflammatory condition in eyes, right eye, might had behcets syndrome. On unknown dates, canker sore in mouth resolved with sequelae and covid resolved. It was unknown if she was enrolled in a covid-19 vaccine trial. Other relevant hisoty and Concomitant drugs were not reported.  primary reporter did not have the lot number information, because the packaging was discarded.   Causality for humira(adalimumab): The reporter's causality for the event(s) of vein occlusion and may had behcets syndrome was not provided. The reporter's causality for the event(s) of inflammatory condition in eyes, right eye, covid onset in Nov2020 and covid onset in Jan2021 with humira(adalimumab) was a reasonable possibility. The reporter's causality for the event(s) of canker sore in mouth with humira(adalimumab) was no reasonable possibility. (Withheld) opinion was that there was no reasonable possibility that the events of vein occlusion, inflammatory condition in eyes, right eye, covid onset in Nov2020 and covid onset in Jan2021 are related to humira(adalimumab). Opinion was that the events of canker sore in mouth and may had behcets syndrome are not assessable.   Causality for Drug: pfizer biontech covid-19 vaccine(tozinameran): The reporter's causality for the event(s) of Vascular occlusion, Eye inflammation (eye inflammation), Canker sores oral (aphthous ulcer), Behcet's syndrome and Covid-19 was reported as possible.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on the available information, there is a reasonable possibility of a causal relationship between the suspect vaccine BNT162B2 (COMIRNATY) and reported events Vaccination failure, COVID-19, Vascular occlusion and behcet''s syndrome which cannot be fully assessed/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.