Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Adverse food reaction, Arthritis, Feeding disorder, Hypoaesthesia, Magnetic resonance imaging
Clinical narrative: Rheumatoid arthritis flares/Hands and wrist were worst/Physician said this could be food; Osteoarthritis; Lost 22 pounds; Could not get out of bed; Could not eat; Could not feel left arm; Arthritis; Pain; Weakness in hands; Rheumatoid arthritis flares/Hands and wrist were worst/Physician said this could be food; MARKETING PROGRAM NAME NOT AVAILIBLE  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-163-4175901-00.  A 66 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administration date 01Apr2021 (Batch/Lot number: unknown) at the age of 65 years as dose 2, single and intramuscular, administration date 01Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation; adalimumab (HUMIRA), first regimen subcutaneous (Lot number: 1158135) at citrate free and second regimen subcutaneous (ongoing) (Lot number: 1157047) at citrate free for rheumatoid arthritis. Relevant medical history included: "COVID-19", start date: 01Nov2020, stop date: 23Nov2020, notes: On 01Nov2020, the patient experienced COVID-19. On 23Nov2020, the COVID-19 resolved. Concomitant medication(s) included: PREDNISONE, start date: 01Sep2021. The following information was reported: RHEUMATOID ARTHRITIS (medically significant) with onset 2021, outcome "recovering", ADVERSE FOOD REACTION (non-serious), outcome "unknown" and all described as "Rheumatoid arthritis flares/Hands and wrist were worst/Physician said this could be food"; OSTEOARTHRITIS (non-serious), outcome "unknown", described as "Osteoarthritis"; WEIGHT DECREASED (non-serious), outcome "unknown", described as "Lost 22 pounds"; MOBILITY DECREASED (non-serious), outcome "unknown", described as "Could not get out of bed"; FEEDING DISORDER (non-serious), outcome "unknown", described as "Could not eat"; HYPOAESTHESIA (non-serious), outcome "unknown", described as "Could not feel left arm"; ARTHRITIS (non-serious), outcome "unknown", described as "Arthritis"; PAIN (non-serious) with onset 17Oct2021, outcome "not recovered", described as "Pain"; MUSCULAR WEAKNESS (non-serious) with onset 17Oct2021, outcome "unknown", described as "Weakness in hands". The patient underwent the following laboratory tests and procedures: magnetic resonance imaging: showed arthritis and osteoarthritis; pain assessment: 7; weight: 22 lbs, notes: Lost. The action taken for adalimumab was dosage not changed. Therapeutic measures were taken as a result of rheumatoid arthritis, adverse food reaction, osteoarthritis, weight decreased, mobility decreased, feeding disorder, hypoaesthesia, arthritis, pain, muscular weakness.  The reporter considered "rheumatoid arthritis flares/hands and wrist were worst/physician said this could be food", "osteoarthritis", "lost 22 pounds", "could not get out of bed", "could not eat", "could not feel left arm", "arthritis", "pain" and "weakness in hands" related to bnt162b2.  Clinical information: The patient was treated with Z-PAK. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  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 provided there is a reasonable possibility of causal association between the event Rheumatoid arthritis with the suspect product bnt162b2