Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Liquid product physical issue, Oxygen saturation, Pain, SARS-CoV-2 test, Suspected COVID-19
Clinical narrative: knee infection; red, sore knee and warm to the touch; red, sore knee and warm to the touch; red, sore knee and warm to the touch; dark pen shaped spot in liquid injection; covid-19; covid-19; soreness after vaccination; 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-163-4188163-00, US-PFIZER INC-202101758046, 21K-163-3929899-00.  A 70 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date 20Mar2021 (Batch/Lot number: unknown) at the age of 69 years as dose 2, single and intramuscular, administration date 20Feb2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation; adalimumab (HUMIRA), first regimen subcutaneous from 2021 (Batch/Lot number: unknown) to 2021 at 80 mg 1x/day, second regimen subcutaneous from Mar2021 (Lot number: 115440) to 17May2021 at 40 mg cyclic (40 mg, cyclic (cf day 8) (40 mg,1 in 2 wk)) and third regimen subcutaneous since 12Jul2021 (ongoing) (Lot number: 115440) at 40 mg cyclic (40 mg, cyclic (cf) (40 mg,1 in 2 wk)) for psoriasis. Relevant medical history included: "Dust allergy" (unspecified if ongoing), notes: House dust allergy manifested by sinus related symptoms.; "Ex Alcohol user/ Wine and mixed drink" (unspecified if ongoing), notes: Ex Alcohol user/ Wine and mixed drink; "Non tobacco user" (unspecified if ongoing); "High cholesterol" (unspecified if ongoing); "Triglycerides" (unspecified if ongoing); "Allergy" (unspecified if ongoing); "Mild atrial fibrillation" (unspecified if ongoing). Concomitant medication(s) included: ASPIRIN COMPOUND [ACETYLSALICYLIC ACID;ASCORBIC ACID]; VITAMIN D [COLECALCIFEROL]; CALCIUM; ATORVASTATIN taken for hypercholesterolaemia; FENOFIBRATE taken for blood triglycerides abnormal; SINGULAIR taken for hypersensitivity; CLARITIN [CLARITHROMYCIN] taken for hypersensitivity; FLONASE [FLUTICASONE PROPIONATE] taken for hypersensitivity; METOPROLOL taken for atrial fibrillation. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset Nov2021, outcome "recovered" (2021), SUSPECTED COVID-19 (medically significant) with onset 30Oct2021, outcome "recovered" (03Dec2021) and all described as "covid-19"; ARTHRITIS INFECTIVE (hospitalization, medically significant) with onset 21May2021, outcome "recovered" (Jun2021), described as "knee infection"; ERYTHEMA (hospitalization), JOINT WARMTH (hospitalization), ARTHRALGIA (hospitalization) all with onset 21May2021, outcome "recovered" (Jun2021) and all described as "red, sore knee and warm to the touch"; PAIN (non-serious) with onset 2021, outcome "recovered" (2021), described as "soreness after vaccination"; LIQUID PRODUCT PHYSICAL ISSUE (non-serious) with onset 06Dec2021, outcome "not recovered", described as "dark pen shaped spot in liquid injection". The patient was hospitalized for erythema, joint warmth, arthralgia (start date: 24May2021, discharge date: 26May2021, hospitalization duration: 2 day(s)). The patient underwent the following laboratory tests and procedures: oxygen saturation: (2021) 95 to 97; sars-cov-2 test: (08Nov2021) positive. The action taken for adalimumab was dosage not changed. Therapeutic measures were taken as a result of arthritis infective, erythema, joint warmth, arthralgia.  The reporter' s assessment of the causal relationship of the events 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.  Clinical indication:Relevant Laboratory & Other Diagnostic Tests :08Nov2021 COVID 19 Nasopharyngeal Test: Positive for Covid 19 2021 Oxygen Level: Ranged from 95 to 97.The patient was treated with Cefalexin and Vitamin C.    The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on the available information in the case provided, the causal association between the events Suspected COVID-19, Drug ineffective and the suspect drug BNT162B2 cannot be excluded considering drug-event temporal relationship. However, based on the available information it cannot be ascertained with reasonable possibility that suspect therapy BNT162B2 has caused/contributed to the reported events Knee infection, red, sore knee and warm to the touch, dark pen shaped spot in liquid injection, hence considered unrelated.