Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Inflammation
Clinical narrative: Inflammation in leg/localized; Knee pain; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-131-4392994-00.  An adult female patient received BNT162b2 (BNT162B2), on 24Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) intramuscular for covid-19 immunisation; adalimumab (HUMIRA), since 08Jan2020 (ongoing) (Batch/Lot number: unknown) at 40 mg (40 mg (1 in 2 wk)), subcutaneous for rheumatoid arthritis, crohn's disease. The patient's relevant medical history included: "Right knee replacement", start date: 2018 (unspecified if ongoing); "Rheumatoid arthritis" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (DOSE 1, SINGLE), administration date: 16Apr2021, for COVID-19 immunization; BNT162b2 (DOSE 2, SINGLE), administration date: 17Sep2021, for COVID-19 immunization, reaction(s): "Vaccination site pain", "Difficulty breathing", "Sore throat", "Knee pain", "Headache", "Stomachache", "Pain in arm", "Vaccination adverse reaction". The following information was reported: ARTHRALGIA (medically significant) with onset 2022, outcome "not recovered", described as "Knee pain"; INFLAMMATION (medically significant) with onset Jul2022, outcome "not recovered", described as "Inflammation in leg/localized". The action taken for adalimumab was unknown.  The reporter's assessment of the causal relationship of "knee pain" and "inflammation in leg/localized" with the suspect product(s) BNT162b2 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 reporter's causality for the event(s) of respiratory difficulty, sore throat, pain localized to left arm and left knee onset in Apr2021, headache, stomachache, pain localized to left arm and left knee onset in Apr2021 and leg inflammation with Humira 40MG/0.4ML (adalimumab) was no reasonable possibility. Opinion is that there is no reasonable possibility that the events of knee pain, reaction to covid-19 vaccine, respiratory difficulty, sore throat, pain localized to left arm and left knee onset in Apr2021, headache, stomachache, pain localized to left arm and left knee onset in Apr2021 and leg inflammation are related to Humira 40MG/0.4ML (adalimumab). The reporter causality on BNT162B2 of knee pain was possible and inflammation localized was not reported.  Clinical course: for event leg inflammation was reported as knee surgery. It was unknown if patient was enrolled in a Covid-19 Vaccine Trial. Primary reporter did not have the lot number information, because the packaging was discarded.   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 provide and plausible temporal association, the causality between BNT162B2 and events cannot be completely 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.,Linked Report(s) : PR-PFIZER INC-PV202200062407 Same patient, same vaccine in different dose, partial same event;