Age: 68.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Arthralgia, Arthropathy, Cerebrovascular accident, Depression, Dizziness
Clinical narrative: stroke; Dizzy/unsteady; rheumatoid arthritis pain; joints worn out; depression; Prostate cancer; 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-163-4438688-00 (Agency).  A 67-year-old male patient received BNT162b2 (BNT162B2), on 22Oct2021 as dose number unknown (booster), single (Batch/Lot number: unknown) at the age of 68 years intramuscular for covid-19 immunisation; adalimumab (HUMIRA), (Batch/Lot number: unknown) at citrate free, subcutaneous for rheumatoid arthritis. The patient's relevant medical history included: "RHEUMATOID ARTHRITIS" (unspecified if ongoing). Concomitant medication(s) included: METHOTREXATE taken for rheumatoid arthritis. Vaccination history included: moderna covid-19 vaccine (Dose 1, Route of Admin: Intra-muscular), administration date: 03Feb2021, when the patient was 67-year-old, for COVID-19 VACCINATION; moderna covid-19 vaccine (Dose 2, Route of Admin: Intra-muscular), administration date: 03Mar2021, when the patient was 67-year-old, for COVID-19 VACCINATION; Moderna covid-19 vaccine (Dose 3 Booster, Note the first 2 shots and the first booster were Moderna), for COVID-19 VACCINATION. The following information was reported: PROSTATE CANCER (medically significant) with onset 2021, outcome "recovering"; CEREBROVASCULAR ACCIDENT (medically significant), outcome "unknown", described as "stroke"; DIZZINESS (non-serious), outcome "recovering", described as "Dizzy/unsteady"; ARTHRALGIA (non-serious), outcome "recovering", described as "rheumatoid arthritis pain"; ARTHROPATHY (non-serious), outcome "unknown", described as "joints worn out"; DEPRESSION (non-serious), outcome "unknown". The action taken for adalimumab was unknown.  Clinical course: In 2021, the patient was diagnosed with prostate cancer, prostate removed then. He still had pain from rheumatoid arthritis but his joints that were just worn out after over 30 years with rheumatoid arthritis. He stated depression about things he could not do like kayaking or riding a bike. He did not give permission to call physician but did give permission to reach out to him if needed. He reported after last COVID booster shot, he became very dizzy and unsteady and could not drive, thought he was having a stroke or something like that. Note the first 2 shots and the first booster were Moderna, and the last booster was Pfizer. He was also on methotrexate for his rheumatoid arthritis. He did not agree to have physician contacted. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. There was no reported medical history.  Causality for humira(adalimumab): The reporter's causality for the event(s) of prostate cancer, dizzy/unsteady unknown onset, rheumatoid arthritis pain, joints worn out, depression and dizzy/unsteady unknown onset was not provided. (Name withheld) opinion is that the event of prostate cancer is not assessable. (Name withheld) opinion is that there is no reasonable possibility that the events of dizzy/unsteady unknown onset, rheumatoid arthritis pain, joints worn out, depression and dizzy/unsteady unknown onset are related to humira(adalimumab).  For Suspect Drug Humira, Causality as per reporter for events Prostate cancer, Dizzy, Arthritic pains, Joint disorder, Depression, Unevaluable event was not reported . Causality as per Mfr for events Prostate cancer was Not assessable and Dizzy, Arthritic pains, Joint disorder, Depression, Unevaluable event was No reasonable possibility. Action taken with drug provided as Unknown. Dechallenge provided as Not Applicable For Suspect Drug Pfizer biontech covid-19 vaccine Causality as per reporter for events Prostate cancer, Dizzy, Arthritic pains, Joint disorder, Depression, Unevaluable event was not reported . Action taken with drug provided as Unknown. Dechallenge provided as Not Applicable  The reporter's assessment of the causal relationship of "prostate cancer", "stroke", "dizzy/unsteady", "rheumatoid arthritis pain", "joints worn out" and "depression" 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.  Follow-up attempts are completed. No further information is expected.; Sender's Comments: Based on the information available, the causal relationship between the reported events Cerebrovascular accident, Arthralgia, Dizziness, Depression and suspect drug 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. Events Prostate cancer and Arthropathy are considered unrelated to suspect drug BNT162B2.