Age: 62.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Gait inability, Rheumatoid arthritis, Seizure
Clinical narrative: could not walk; seizure were began convulsing; worsening of Rheumatoid arthritis symptoms; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): US-ABBVIE-5386697.  A 62-year-old male patient received bnt162b2 (BNT162B2), on 19Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 62 years intramuscular for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown), all intramuscular for covid-19 immunisation; adalimumab (HUMIRA), since 02Sep2003 (Batch/Lot number: unknown), subcutaneous. The patient's relevant medical history included: "Rheumatoid arthritis" (ongoing); "Obese" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: RHEUMATOID ARTHRITIS (medically significant) with onset 28Aug2021, outcome "recovering", described as "worsening of Rheumatoid arthritis symptoms"; SEIZURE (medically significant) with onset 10Dec2021, outcome "unknown", described as "seizure were began convulsing"; GAIT INABILITY (non-serious), outcome "unknown", described as "could not walk". The action taken for adalimumab was unknown. Clinical course: The patient had been on Humira over twenty years and took the covid shots and received the first Pfizer booster . He believed his autoimmune disease or response caused the severe reaction and health problems. After taking a booster, he had begun experiencing worsening of rheumatoid arthritis symptoms. He could not walk and his left ankle was swollen, also the pain was intolerable. He experienced a seizure on 10Dec2021 and he began convulsing. Agency's Alternative Etiology for could not walk with Adalimumab Solution for Injection was more likely related to concurrent rheumatoid arthritis and it's aggravation in this aged obese patient and for worsening of Rheumatoid arthritis symptoms with Adalimumab Solution for Injection was more likely an aggravation post covid shot in this aged obese patient with underlying rheumatoid arthritis. Primary reporter did not have the lot number information, because the packaging was discarded.  The reporter's assessment of the causal relationship of "seizure were began convulsing", "worsening of rheumatoid arthritis symptoms" and "could not walk" 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.  Causality assessment: The reporter's causality for the events of Unable to walk, Convulsive seizure and Rheumatoid arthritis aggravated with BNT162b2, Adalimumab Solution for Injection, COVID-19 vaccine was not provided. Agency's opinion was that the causality for the event Convulsive seizure with Adalimumab Solution for Injection was Not Assessable and for events Unable to walk and Rheumatoid arthritis aggravated with Adalimumab Solution for Injection was No Reasonable Possibility. Causality assessment for events Unable to walk, Convulsive seizure and Rheumatoid arthritis aggravated with Comirnaty and COVID-19 vaccine was not reported per Agency, Non-Health Care Professional, Introspection. Causality assessment for events Unable to walk and Rheumatoid arthritis aggravated with Humira was No Reasonable Possibility per Agency, Introspection and was not reported per Non-Health Care Professional, Introspection. Assessment Results for event Convulsive seizure with Humira was not assessable per Agency, Introspection and was not reported per Non-Health Care Professional, Introspection.  The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.; Sender's Comments: The reported Seizure, Rheumatoid arthritis aggravated, and Gait inability are unrelated to bnt162b2 vaccine but more likely concurrent medical condition or related to the pre-existing rheumatoid arthritis in this aged obese patient. Case will be reassessed if follow up information becomes available.