Age: 62.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Arthropathy, Body temperature, COVID-19, Drug ineffective, Magnetic resonance imaging
Clinical narrative: she also had covid-19; she also had covid-19; her white blood count was elevated; knee had not 100 percent; gained weight; This is a solicited report based on the information received by Pfizer (Mfr control no: 20K-163-3678612-00). A 62-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), via intramuscular on 04May2021 (at the age of 62-year-old) as dose 2, single, and dose 1 intramuscular on 14Apr2021 (Batch/Lot number was not reported) as dose 1, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous from 25Dec2020 to an unspecified date, at 40 mg for crohn's disease. Medical history included inflammation from 24Nov2020 to an unknown date, the patient had magnetic resonance imaging on the 24Nov2020 that showed inflammation but nothing torn, device physical property issue from an unknown date and unknown if ongoing Detachment of device (Device physical property issue), arthralgia from an unknown date and unknown if ongoing, Painful joints, complication associated with device from an unknown date and unknown if ongoing, joint swelling from an unknown date and unknown if ongoing; Knee swelling, fear of disease from an unknown date and unknown if ongoing, hypersomnia from an unknown date and unknown if ongoing; Sleep excessive, gait disturbance from an unknown date and unknown if ongoing; Stumbling, immunodeficiency from an unknown date and unknown if ongoing, exposure to sars-cov-2 from an unknown date and unknown if ongoing, frequent bowel movements from an unknown date and unknown if ongoing, wrong dosage dispensed from an unknown date and unknown if ongoing, feeling miserable from an unknown date and unknown if ongoing, knee arthropathy from an unknown date and unknown if ongoing, loss of smell from an unknown date and unknown if ongoing, oral intake reduced from an unknown date and unknown if ongoing, mobility decreased from an unknown date and unknown if ongoing, contusion of lower leg from an unknown date and unknown if ongoing, medical device site joint pain from an unknown date and unknown if ongoing, stress from an unknown date and unknown if ongoing, swelling from an unknown date and unknown if ongoing, scar from an unknown date and unknown if ongoing, loss of taste from an unknown date and unknown if ongoing, crohn's disease aggravated from an unknown date and unknown if ongoing, pain legs from an unknown date and unknown if ongoing, headache from an unknown date and unknown if ongoing, nauseous from an unknown date and unknown if ongoing, tenderness from an unknown date and unknown if ongoing, allergy from an unknown date and unknown if ongoing, nerve pain from an unknown date and unknown if ongoing, pain in arm from an unknown date and unknown if ongoing, peripheral neuropathic pain from an unknown date and unknown if ongoing. Concomitant medications included oxycodone taken for an unspecified indication, start and stop date were not reported; tramadol taken for an unspecified indication, start and stop date were not reported; vitamin b complex taken for an unspecified indication, start and stop date were not reported; ondansetron (ZOFRAN) taken for an unspecified indication, start and stop date were not reported; aspirin [acetylsalicylic acid] taken for an unspecified indication, start and stop date were not reported. On an unspecified date in May2021, the patient experienced she also had covid-19, her white blood count was elevated, knee had not 100 percent, gained weight, rotator cuff surgery. The patient underwent lab tests and procedures which included body temperature: unknown result on an unspecified date, magnetic resonance imaging: unknown result on 24Nov2020, sars-cov-2 test: unknown result on an unspecified date, sars-cov-2 test: positive on May2021 she also had covid-19, weight: gained on an unspecified date in May2021, white blood cell count: elevated on May2021. The outcome of the events was unknown.  Causality for Humira with she also had covid-19, her white blood count was elevated, knee had not 100 percent, gained weight, rotator cuff surgery per reporter was not reported per Mfr. was no reasonable possibility. The reporter's assessment of the causal relationship of the eventsshe also had covid-19, her white blood count was elevated, knee had not 100 percent, gained weight, rotator cuff surgery with the suspect product BNT162B2 was no reasonable possibility.   The lot number for BNT162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on available information, a possible contributory role of BNT162B2 vaccine cannot be excluded for the reported events due to temporal relationship.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