Age: 82.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Arthralgia, Headache, Hospitalisation, Inappropriate schedule of product administration, Joint stiffness
Clinical narrative: Hospitalisation; in Rheumatoid arthritis stiffness pain; Itching all over; On 18Feb2021, she received first dose COVID-19; On 23Feb2021, she received second dose COVID-19; Joint stiffness/increased in Rheumatoid arthritis stiffness pain and stiffness in hand; Headache; Arthralgia aggravated; Vaccination adverse reaction; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient.  A 82 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date 23Feb2021 (Batch/Lot number: unknown) at the age of 82 years as dose 2, single and intramuscular, administration date 18Feb2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous since 2021 (Batch/Lot number: unknown) for rheumatoid arthritis. Relevant medical history included: "no" (unspecified if ongoing), notes: Other relevant history: , No known allergies, no relevant medical history. There were no concomitant medications. The following information was reported: RHEUMATOID ARTHRITIS (medically significant), outcome "unknown", described as "in Rheumatoid arthritis stiffness pain"; HOSPITALISATION (hospitalization), outcome "unknown", described as "Hospitalisation"; INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 18Feb2021, outcome "unknown", described as "On 18Feb2021, she received first dose COVID-19; On 23Feb2021, she received second dose COVID-19"; JOINT STIFFNESS (non-serious) with onset 2021, outcome "not recovered", described as "Joint stiffness/increased in Rheumatoid arthritis stiffness pain and stiffness in hand"; PRURITUS (non-serious) with onset 25Nov2021, outcome "not recovered", described as "Itching all over"; HEADACHE (non-serious) with onset 2021, outcome "recovered" (2021), described as "Headache"; ARTHRALGIA (non-serious) with onset 2021, outcome "not recovered", described as "Arthralgia aggravated"; VACCINATION COMPLICATION (non-serious) with onset 2021, outcome "unknown", described as "Vaccination adverse reaction". The action taken for adalimumab was unknown.  The reporter's causality the event of increased in rheumatoid arthritis pain and stiffness in hand Onset in 2021, itching all over, headaches and increased arthritis pain and stiffness in hand onset in 2021 with Humira (Adalimumab) was a reasonable possibility and not reported for rest of the events however causality for suspect drug Pfizer Biontech Covid-19 Vaccine (Tozinameran) (Tozinameran) for event Hospitalizations, Joint stiffness, Itching all over, Headache, Arthralgia aggravated was Not reported and for event vaccination adverse reaction it was probable.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association between the events Rheumatoid Arthritis, Hospitalizations, Joint stiffness, Itching all over, Headache, Arthralgia aggravated , event vaccination adverse reaction and the vaccine (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.",Linked Report(s) : 21K-163-4177774-00