Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain assessment, Pain in extremity, Plantar fasciitis, Pyrexia
Clinical narrative: Rheumatoid arthritis flare up; Plantar fasciitis; Carpal tunnel syndrome; Swollen lymph nodes; Pain in arm; Shoulder pain; Ache; Chills; Fever; In 2021, patient received booster dose COVID-19 vaccine manufactured by Pfizer.; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient. Other Case identifier(s): 21K-163-4210612-00.  A 56 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date 2021 (Batch/Lot number: unknown) at the age of 56 years as dose 3 (booster), single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (ongoing) (Lot number: 1153257) for rheumatoid arthritis. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1., Route of administration: Intra-muscular), administration date: 20Mar2021, when the patient was 56 years old, for Covid-19 immunization; Bnt162b2 (DOSE 2, Route of administration: Intra-muscular), administration date: 20Apr2021, when the patient was 56 years old, for Covid-19 immunization. The following information was reported: RHEUMATOID ARTHRITIS (medically significant), outcome "not recovered", described as "Rheumatoid arthritis flare up"; IMMUNISATION (medically significant) with onset 2021, outcome "unknown", described as "In 2021, patient received booster dose COVID-19 vaccine manufactured by Pfizer."; PLANTAR FASCIITIS (non-serious), outcome "unknown", described as "Plantar fasciitis"; CARPAL TUNNEL SYNDROME (non-serious), outcome "unknown", described as "Carpal tunnel syndrome"; LYMPHADENOPATHY (non-serious), outcome "unknown", described as "Swollen lymph nodes"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Pain in arm"; ARTHRALGIA (non-serious), outcome "unknown", described as "Shoulder pain"; PAIN (non-serious), outcome "unknown", described as "Ache"; CHILLS (non-serious), outcome "unknown", described as "Chills"; PYREXIA (non-serious), outcome "unknown", described as "Fever". The patient underwent the following laboratory tests and procedures: pain assessment: elevated. The action taken for adalimumab was dosage not changed.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.  Additional information: On unknown dates, the patient experienced Rheumatoid Arthritis Flare Up, Right Foot Plantar Fasciitis, Carpal, Tunnel in Wrists, Lymph Nodes Swollen, Arm Hurting, Shoulder Pain, Achiness, Chill and Fever. Pfizer Biontech COVID-19 VACCINE (TOZINAMERAN) was also considered suspect.It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. On 20Mar2021, patient received first dose COVID-19 vaccine manufactured by Pfizer.On 20Apr2021, patient received second dose COVID-19 vaccine manufactured by Pfizer.  Causality for HUMIRA (ADALIMUMAB) 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 Right Foot Plantar Fasciitis and Carpal Tunnel in Wrists was not provided. The reporter's causality for the event(s) of Lymph Nodes Swollen, Arm Hurting, Shoulder Pain, Achiness, Chill and Fever with HUMIRA (ADALIMUMAB) was no reasonable possibility. Relevant Laboratory & Other Diagnostic TestsUnknown date PAIN SCALE: ElevatedIn 2021.  Causality: Rheumatoid arthritis flare up (Rheumatoid arthritis). Action(s) taken with drug: Dose Not Changed. Causality as per reporter (Drug/Vaccine): Reasonable possibility. Dechallenge: N/A  Plantar fasciitis (Plantar fasciitis- Action(s) taken with drug: Dose Not Changed. Causality as per reporter (Drug/Vaccine): Not Reported. Dechallenge: N/A Carpal tunnel syndrome (Carpaltunnelsyndrome) Action(s) taken with drug: Dose Not Changed. Causality as per reporter (Drug/Vaccine): Not Reported. Dechallenge: N/A.  Swollen lymph nodes (Lymphadenopathy) Action(s) taken with drug: Dose Not Changed. Causality as per reporter (Drug/Vaccine): No reasonable possibility. Dechallenge: N/A Pain in arm (Pain in extremity) Action taken with drug: Dose Not Changed. Causality as per reporter (Drug/Vaccine): No reasonable possibility. Dechallenge: N/A.  Shoulder pain (Arthralgia) Action(s) taken with drug: Dose Not Changed. Causality as per reporter (Drug/Vaccine): No reasonable possibility. Dechallenge: N/A. Ache (Pain) Action(s) taken with drug: Dose Not Changed. Causality as per reporter (Drug/Vaccine):No reasonable possibility. Dechallenge: N/A.  Chills (Chills) Action(s) taken with drug: Dose Not Changed. Causality as per reporter (Drug/Vaccine): No reasonable possibility. Dechallenge: N/A Fever (Pyrexia). Action(s) taken with drug: Dose Not Changed. Causality as per reporter (Drug/Vaccine): No reasonable possibility. Dechallenge: N/A Report Source: Study Report type: Initial Lab Result Test name: Pain Scale Test date: Unknown.; Sender's Comments: Based on the information, there is reasonable possibility of causal association between the events  Immunization ,Rheumatoid Arthritis Flare Up, Right Foot Plantar Fasciitis, Carpal, Tunnel in Wrists, Lymph Nodes Swollen, Arm Hurting, Shoulder Pain, Achiness, Chill and Fever and the suspect vaccine BNT162B2. 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.