Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity, Rheumatoid arthritis
Clinical narrative: Rheumatoid Arthritis Flare Up; Fatigue; Hand pain; Reaction information:  Age Yrs: Unknown Sex: Female  Reaction Information Seq. No.:1 Reaction: Fatigue (Fatigue) Start Date: ?? Stop Date: ??  Seq. No.:2 Reaction: Rheumatoid arthritis flare up (Rheumatoid arthritis) Start Date: ?? Stop Date: ??  Seq. No.:3 Reaction: Hand pain (Pain in extremity) Start Date: ?? Stop Date: ??  Describe Reaction(s) (include relevant test/lab data): Fatigue (Fatigue) - Unknown Rheumatoid arthritis flare up (Rheumatoid arthritis) - Not recovered/not resolved Hand pain(Pain in extremity) - Unknown  Solicited report from the a consumer of a female with events of non-serious Pfizer vaccinations caused fatigue, rheumatoid arthritis flare up and hands hurt from over use with Humira (adalimumab). There was no reported medical history.  On unknown dates, the patient experienced Pfizer vaccinations caused fatigue rheumatoid arthritis flare up and hands hurt from over use. Pfizer biontech covid-19 vaccine. (TOZINAMERAN) was also considered suspect.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  Causality for Humira (adalimumab) The reporter's causality for the event(s) of Pfizer vaccinations caused Fatigue with Humira(Adalimumab) was no reasonable possibility. The reporter's causality for the event(s) of Rheumatoid Arthritis Flare Up with Humira (Adalimumab) was a reasonable possibility. The reporter's causality for the event(s) of hands hurt from over use was not provided  II. Suspect drug(s) information: Suspect Drug(s) (include generic name): 1) HUMIRA (ADALIMUMAB) Route of administration: 1) Subcutaneous Indications for use:  1) MODERATE TO SEVERE RHEUMATOID ARTHRITIS  Product-Reaction level Seq.No.: 1 Drug: HUMIRA (ADALIMUMAB)  Route of Admin: 1) Subcutaneous Therapy Dates/Duration: 1) 04Jan2017 - Ongoing  Causality 1) Fatigue (Fatigue) Action(s) taken with drug: Dose Not Changed Causality as per reporter (Drug/Vaccine): Not Related Dechallenge: N/A  2) Rheumatoid arthritis flare up (Rheumatoid arthritis) Action(s) taken with drug: Dose Not Changed Causality as per reporter (Drug/Vaccine): Probable Dechallenge: N/A  3) Hand pain (Pain in extremity) Action(s) taken with drug: Dose Not Changed Causality as per reporter (Drug/Vaccine): Not Reported Dechallenge: N/A  2) PFIZER BIONTECH COVID-19 VACCINE(TOZINAMERAN) Route of administration: 2) Intramuscular Therapy Dates(From/To): 2) 02Feb2021 Indications for use:  2) COVID-19 Vaccine (COVID-19 Vaccine)  Seq.No.: 2 Drug: PFIZER BIONTECH COVID-19 VACCINE(TOZINAMERAN) Daily Dose:  1) First Dose (1 in 1 Once) 2) Second Dose (1 in 1 Once) 3) Third Dose/ Booster Dose (1 in 1 Once) Route of Admin:  1) Intramuscular 2) Intramuscular 3) Intramuscular Therapy Dates/Duration:  1) 02Feb2021 -  02Feb2021 2) 02Mar2021 - 02Mar2021  3) 19Aug2021 - 19Aug2021  Causality 1) Fatigue (Fatigue) Action(s) taken with drug: Unknown Causality as per reporter (Drug/Vaccine): Probable Dechallenge: N/A  2) Rheumatoid arthritis flare up (Rheumatoid arthritis) Action(s) taken with drug: Unknown Causality as per reporter (Drug/Vaccine): Not Reported Dechallenge: N/A  3) Hand pain (Pain in extremity) Action(s) taken with drug: Unknown Causality as per reporter (Drug/Vaccine): Not Reported Dechallenge: N/A  Did event abate after stopping drug: NA  III. Concomitant drugs and history: Concomitant Drugs Not Reported  Other relevant history: Not reported.  No follow-up attempts are Needed; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on possible temporal association the causal role of BNT162B2 Vaccine cannot be excluded for reported events .Case will be reviewed further on receipt of FU information. The impact of this report on the benefit/risk profile of the Pfizer drug 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.