Age: 53.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Ankle deformity, Body temperature, Central nervous system inflammation, Dermatochalasis, Feeling hot
Clinical narrative: Psoriatic arthritis aggravated/ psoriatic arthritis flare; Ankle deformity/ deformed in feet, ankles, fingers; Foot deformity/ deformed in feet, ankles, fingers; Finger deformity/ deformed in feet, ankles, fingers; Raynaud's disease; Sleep unwell/ not sleeping well; Pain; Central nervous system inflammation/ neurological inflammation; Low grade fever; Sagging eyelid skin/ facial and eyelid sagging; Skin laxity; Feeling of warmth/ felt gentle warmth; Nail psoriasis; Vaccination site pain/ injection site hurt in arm; This is a solicited report based on the information received by Pfizer (Mfr. Control No.: 21K-163-3861806-00). A non-contactable 53-year-old adult female consumer (patient) reported for herself. A 53-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE (tozinameran), Solution for injection. Batch/Lot number was not reported), dose 1 intramuscular, administered in Deltoid Left (Left shoulder) on 10Apr2021 (at the age of 53-years-old) as DOSE 1, SINGLE for COVID-19 immunization, adalimumab (HUMIRA), subcutaneous from an unspecified date (Batch/Lot number was not reported) to an unspecified date, at for psoriatic arthropathy. The patient had a relevant medical history of sjogren's syndrome, raynaud's syndrome, postural orthostatic tachycardia syndrome, allergy, hypermobility syndrome, arthritis, nocturnal seizures, rem sleep behavior disorder, thrombocytopenia, hypothyroidism and endometriosis. Concomitant medication included levothyroxine sodium (SYNTHROID). It was unknown if patient was enrolled in a COVID-19 vaccine trial. On unknown dates, the patient experienced raynaud's disease, deformed in feet, ankles, fingers, not sleeping well, psoriatic arthritis flare and humira had no effect. In 2021, the patient experienced nail psoriasis and COVID vaccine injection site hurt in arm. On 10Apr2021, the patient experienced facial and eyelid sagging, neurological inflammation, felt gentle warmth, low grade fever and pain. In 2021, the COVID vaccine injection site hurt in arm and low grade fever resolved. On unknown dates, facial and eyelid sagging, neurological inflammation, felt gentle warmth and pain resolved. Pfizer biontech COVID-19 vaccine (tozinameran) was also considered suspect. Causality for humira(adalimumab). The reporter's causality for the events of facial and eyelid sagging onset 10Apr2021, facial and eyelid sagging onset 10Apr2021, neurological inflammation, felt gentle warmth, nail psoriasis, raynaud's disease, COVID vaccine injection site hurt in arm, deformed in feet, ankles, fingers unknown onset, deformed in feet, ankles, fingers unknown onset, deformed in feet, ankles, fingers unknown onset, low grade fever, not sleeping well, psoriatic arthritis flare, pain and humira had no effect was not provided. On 22Jul2021, received updates to study information, event information, reporter opinion of causality, suspect drug information, laboratory/diagnostic procedures and narrative description. The events of nail psoriasis, raynaud's disease, COVID vaccine injection site hurt in arm, deformed in feet, ankles, fingers, not sleeping well and psoriatic arthritis flare were added. Causality as per reporter (Drug/Vaccine) for all the events not reported. The patient underwent lab tests and procedures which included body temperature: unknown results on 10Apr2021 Low Grade Fever. The outcome of the event psoriatic arthropathy was not recovered, nail psoriasis, raynaud's phenomenon, ankle deformity, foot deformity and finger deformity were unknown while other events were recovered on an unspecified date in 2021.   No follow-up attempts are needed. No further information is expected.; Sender's Comments: Based on the information provided in narrative, The causal relation between the events of Vaccination site reaction, pain, fever, feeling of hot, Raynaud 'syndrome and suspected vaccine BNT162B2 cannot be totally excluded. The reported event of psoriatic arthropathy ,nail psoriasis, deformity in feet, deformity in ankles, deformity in fingers are consider not related to suspected vaccine and more likely due to ongoing medical history of Psoriasis .Reported event of sleeping unwell was considered unrelated to suspected vaccine more likely due to ongoing  rem sleep behavior disorder. Event Neurological inflammation is consider unrelated to suspected vaccine and likely due to Sjogren's disease.  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.,Linked Report(s) : 21K-163-3861806-00