Age: 58.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Chills, Headache, Immunisation, Lethargy, Malaise
Clinical narrative: Booster; Moderate to severe rheumatoid arthritis flareups/ left thumb and wrist and ankle; Did not feel well; Chills; Very lethargic; Achy; Dull headache; Stiffness; This is a solicited report from a marketing program based on the information received by Pfizer manufacture number (21K-163-4140354-00) from a contactable consumer (patient).   A 58-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via intramuscular on 18Oct2021 (Batch/Lot number was not reported) as DOSE 3 (BOOSTER), SINGLE for covid-19 vaccination; adalimumab (HUMIRA), subcutaneous from an unspecified date (Batch/Lot number was not reported) to an unspecified date, at citrate free for moderate to severe rheumatoid arthritis. The patient medical history and concomitant medications were not reported. On 01Mar2021, patient received first dose COVID-19 Vaccine manufactured by Pfizer/BioNTech. On 19Mar2021, he received second dose COVID-19 Vaccine manufactured by Pfizer/BioNTech. On 18Oct2021, he received booster dose COVID-19 Vaccine manufactured by Pfizer/BioNTech. In Oct2021, the patient experienced did not feel well, chills, very lethargic, moderate to severe rheumatoid arthritis flareups/ left thumb and wrist and ankle, achy, dull headache and stiffness. In Oct2021, the did not feel well, chills, very lethargic, moderate to severe rheumatoid arthritis flareups/ left thumb and wrist and ankle and achy resolved. PFIZER BIONTECH COVID-19 VACCINE (TOZINAMERAN) was also considered suspect. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The outcome of events headache dull and stiffness was not recovered, outcome of other events was recovered in Oct2021.   Causality for HUMIRA(ADALIMUMAB): The reporter's causality for the events of did not feel well, chills, very lethargic, moderate to severe rheumatoid arthritis flareups/ left thumb and wrist and ankle, achy and dull headache with HUMIRA(adalimumab) was no reasonable possibility. the reporter's causality for the event of stiffness was not provided. Causality for BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE): The reporter's causality for the events of did not feel well, chills, very lethargic, achy, dull headache and stiffness with BNT162B2 was possible, of event moderate to severe rheumatoid arthritis flareups/ left thumb and wrist and ankle was not reported.  The reporter's assessment of the causal relationship of the event moderate to severe rheumatoid arthritis flareups/ left thumb and wrist and ankle with the suspect vaccine 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.    No follow-up attempts are needed; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the  information in the case report, a possible causal relationship between the events 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.