Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Allergy to vaccine, Blister, COVID-19, Dermatitis allergic, Drug ineffective
Clinical narrative: COVID-19; COVID-19; had a nodule on lung; eyes got worse; Allergy to vaccine; allergic reaction, broke out, a blister kept coming back on her finger; allergic reaction, broke out, a blister kept coming back on her finger; itching so bad; Allergic rash; Urinary tract infection developed into kidney infection; This is a solicited report received from contactable reporter(s) (Consumer or other non-HCP) for a sponsored program. The reporter is the patient.  A 58-year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date Oct2021 (Batch/Lot number: unknown) at the age of 58 years as dose number unknown, single for covid-19 immunisation; adalimumab (HUMIRA), first regimen subcutaneous (Batch/Lot number: unknown) till 2020 and second regimen subcutaneous since Jul2020 (Batch/Lot number: unknown) for uveitis, psoriatic arthropathy. Relevant medical history included: "Covid-19", start date: 20Oct2020 (unspecified if ongoing); "Kidney infection", start date: Sep2021 (unspecified if ongoing); "could not breathe even after had the breathing treatments" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19"; PULMONARY MASS (medically significant), outcome "unknown", described as "had a nodule on lung"; VACCINATION SITE PRURITUS (medically significant) with onset Oct2021, outcome "recovered" (2021), described as "itching so bad"; EYE DISORDER (medically significant), outcome "unknown", described as "eyes got worse"; ALLERGY TO VACCINE (medically significant) with onset Oct2021, outcome "recovering", described as "Allergy to vaccine"; BLISTER (medically significant), HYPERSENSITIVITY (medically significant) all with onset Oct2021, outcome "unknown" and all described as "allergic reaction, broke out, a blister kept coming back on her finger"; URINARY TRACT INFECTION (medically significant) with onset 2021, outcome "recovering", described as "Urinary tract infection developed into kidney infection"; DERMATITIS ALLERGIC (medically significant) with onset Oct2021, outcome "unknown", described as "Allergic rash". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (2020) positive. The action taken for adalimumab was dosage increased.  Clinical course: In Oct2021, after she had the covid vaccine, she had allergic reaction, broke out, a blister kept coming back on her finger. It looked like she had chicken pox or measles and was just itching so bad, and it took about three weeks for the itching to stop. The physician was keeping an eye on her. She had some nodules that had to be removed due to lungs situation. The patient had a nodule on lung. It was a growth in between the left lung and artery. It was right near the heart, and in order for to have surgery it has to be open heart surgery so instead of surgery they Allergic reaction to Covid/Vaccine/Broke out and blister kept coming back on finger were going to watch it, as she not one to heal so well after a surgery. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  Since no reporter determination has been received, the case is managed based on the company causality assessment. The reporter's assessment of the causal relationship of the reported event with the suspect product was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events and BNT162B2.  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.