Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nausea, Pain, Pain in extremity, Rheumatoid arthritis
Clinical narrative: Rheumatoid arthritis flare up; Nausea; Headache; Hand pain; Pain worsened; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4388643-00 (Company).  A 65-year-old female patient received BNT162b2 (BNT162B2), on 24Apr2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 65 years intramuscular for covid-19 immunisation; adalimumab (HUMIRA), first regimen since 08Jan2018 (Batch/Lot number: unknown) and second regimen since 02Mar2018 (ongoing) (Batch/Lot number: unknown), all subcutaneous for rheumatoid arthritis, uveitis. The patient's relevant medical history included: "COVID-19", start date: 20Jan2021 (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose 1, Route of Admin: Intramuscular), administration date: 04Sep2021, when the patient was 65-year-old, for Covid-19 immunization, reaction(s): "Glaucoma", "Ill feeling"; BNT162b2 (Dose 1, Route of Admin: Intramuscular), administration date: 04Sep2021, when the patient was 65-year-old, for Covid-19 Immunization, reaction(s): "Difficulty in walking", "Tissue adhesion", "Pain localized", "Uveitis"; BNT162b2 (Dose 2, Route of Admin: Intramuscular), administration date: 28Sep2021, when the patient was 65-year-old, for Covid-19 Immunization, reaction(s): "Glaucoma", "Ill feeling", "Difficulty in walking", "Tissue adhesion", "Pain localized", "Uveitis". The following information was reported: RHEUMATOID ARTHRITIS (medically significant), outcome "not recovered", described as "Rheumatoid arthritis flare up"; NAUSEA (non-serious), outcome "unknown"; HEADACHE (non-serious), outcome "unknown"; PAIN IN EXTREMITY (non-serious), outcome "not recovered", described as "Hand pain"; PAIN (non-serious), outcome "not recovered", described as "Pain worsened". The action taken for adalimumab was dosage not changed. Clinical course: Pfizer booster injection caused nausea and headache, hands hurt right thumb, pain worse than left and rheumatoid arthritis flare up. Pfizer Biontech COVID-19 vaccine (tozinameran) was also considered suspect. It was unknown if patient was enrolled in a covid-19 vaccine trial.   The reporter's assessment of the causal relationship of "rheumatoid arthritis flare up", "hand pain" and "pain worsened" with the suspect product(s) BNT162b2 was not reported at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment. The reporter considered "nausea" and "headache" related to BNT162b2.  No follow up attempts are possible; Information about lot/batch number cannot be requested. No further information is expected.; Sender's Comments: Based on the information provided in the narrative , a possible contributory role of the suspect vaccine  to reported event of  "rheumatoid arthritis flare up", "hand pain" headache , nausea and "pain worsened"  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.