Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Body temperature, Illness, Nasal congestion, Peripheral swelling
Clinical narrative: She had trigger finger surgery.; Rash in the arm; fever; swollen arm; She got sick due to Covid 19 vaccine; she had stuffy and runny nose; runny nose; MARKETING PROGRAM NAME IS NOT AVIALABLE  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): 21K-163-3923676-00.  A 61 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date 05Feb2021 (Batch/Lot number: unknown) at the age of 61 years as dose 1, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous, administration date 2010 (Batch/Lot number: unknown), subcutaneous, administration date Jun2016 (Batch/Lot number: unknown) and subcutaneous, administration date 03Apr2021 (ongoing) (Batch/Lot number: unknown) for ankylosing spondylitis, uveitis, irritable bowel syndrome, diverticulitis, plantar fasciitis. Relevant medical history included: "Back pain", start date: 2010 (unspecified if ongoing), notes: In 2010, the patient experienced recurring back pain, recurring sinus infection and recurring flare up ankylosing spondilitis.; "Sinus infection", start date: 2010 (unspecified if ongoing), notes: In 2010, the patient experienced recurring back pain, recurring sinus infection and recurring flare up ankylosing spondilitis.; "flare up ankylosing spondilitis", start date: 2010 (unspecified if ongoing); "Knee pain", start date: 2016 (unspecified if ongoing), notes: In 2016, the patient experienced recurring knee pain.; "bone fusion in the lower back", start date: Jan2016 (unspecified if ongoing), notes: In Jan2016, the patient experienced bone fusion in the lower back. In Jan2016, the bone fusion in the lower back resolved.; "torn patella knee", start date: Mar2016 (unspecified if ongoing), notes: In Mar2016, the patient experienced torn patella knee.; "trigger finger release", start date: Aug2021 (unspecified if ongoing), notes: In Aug2020, the patient experienced trigger finger release.; "Fall", start date: 15Jan2021 (unspecified if ongoing), notes: On 15Jan2021, the patient experienced fall.; "Non-Smoker" (unspecified if ongoing); "Abstains From Alcohol" (unspecified if ongoing); "Gluten Allergy" (unspecified if ongoing); "Silicon Allergy" (unspecified if ongoing); "Stomach Cramps" (unspecified if ongoing); "Rash" (unspecified if ongoing); "Latex Allergy" (unspecified if ongoing); "high blood pressure" (unspecified if ongoing). Concomitant medication(s) included: AMLODIPINE taken for hypertension; LOSARTAN taken for hypertension. The following information was reported: TRIGGER FINGER (intervention required), outcome "recovering", described as "She had trigger finger surgery."; PYREXIA (non-serious) with onset 26Feb2021, outcome "unknown", described as "fever"; PERIPHERAL SWELLING (non-serious) with onset 26Feb2021, outcome "recovered with sequelae" (05Mar2021), described as "swollen arm"; ILLNESS (non-serious) with onset 26Feb2021, outcome "recovered" (Apr2021), described as "She got sick due to Covid 19 vaccine"; NASAL CONGESTION (non-serious) with onset 26Feb2021, outcome "recovered" (Apr2021), described as "she had stuffy and runny nose"; RHINORRHOEA (non-serious) with onset 26Feb2021, outcome "recovered" (Apr2021), described as "runny nose"; RASH (non-serious) with onset 20Mar2021, outcome "recovered" (31Mar2021), described as "Rash in the arm". The patient underwent the following laboratory tests and procedures: blood test: (05Feb2021) unknown result; body temperature: (unspecified date) unknown result. The action taken for adalimumab was unknown. Therapeutic measures were taken as a result of trigger finger.  Clinical course: On 26Feb2021, the patient experienced sick because of covid 19 vaccine, fever and swollen arm. On 05Mar2021, the swollen arm resolved with sequelae. On 20Mar2021, the patient experienced rash in the arm. On 31Mar2021, the rash in the arm resolved. On 26Feb2021 she had stuffy and runny nose which was recovered in Apr2021. Causality of runny nose was not related. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. On 26Feb2021, patient received first dose COVID-19 Vaccine manufactured by Pfizer BioNTech. On 27Mar2021, patient received second dose COVID-19 Vaccine manufactured by Pfizer BioNTech.  Causality for bnt162b2 (BNT162B2): The reporter's causality for the event(s) of trigger finger release, sinusitis recurrent, sickness, fever were not assessable and event(s) swollen arm, rash over arms were not related.  Causality for Humira 40MG/0.4ML(Adalimumab): The reporter's causality for the event(s) of swollen arm and rash in the arm with humira 40mg/0.4ml(adalimumab) was no reasonable possibility. The reporter's causality for the event(s) of trigger finger release, recurring sinus infection, sick because of covid 19 vaccine and fever was not provided. opinion is that there is no reasonable possibility that the events of trigger finger release, sick because of covid 19 vaccine, fever, swollen arm and rash in the arm are related to humira 40mg/0.4ml(adalimumab). opinion is that there is a reasonable possibility that the event of recurring sinus infection is related to humira 40mg/0.4ml(adalimumab).   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information provided, a causal association between reported events trigger finger, pyrexia, peripheral swelling, illness, nasal congestion, rhinorrhea, rash, and the suspect BNT162b2 cannot be excluded. 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.