Age: 65.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Adhesion, Gait disturbance, Glaucoma, Malaise, Pain
Clinical narrative: Glaucoma; Uveitis; Difficulty in walking; Tissue adhesion; Pain localised; Ill feeling; 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 (AbbVie).  A 65-year-old female patient received BNT162b2 (BNT162B2), on 04Sep2021 as dose 1, single (Batch/Lot number: unknown) at the age of 65 years and on 28Sep2021 as dose 2, single (Batch/Lot number: unknown), all intramuscular for covid-19 immunisation; adalimumab (HUMIRA), first regimen since 08Jan2018 (Lot number: 1155913) and second regimen since 02Mar2018 (ongoing) (Lot number: 1155993), 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. The following information was reported: GLAUCOMA (medically significant), outcome "not recovered"; UVEITIS (medically significant), outcome "not recovered"; GAIT DISTURBANCE (non-serious), outcome "not recovered", described as "Difficulty in walking"; ADHESION (non-serious), outcome "not recovered", described as "Tissue adhesion"; PAIN (non-serious), outcome "not recovered", described as "Pain localised"; MALAISE (non-serious), outcome "recovered", described as "Ill feeling". The action taken for adalimumab was dosage not changed. 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 glaucoma, illness with Humira (Adalimumab) was no reasonable possibility. The reporter's causality for the event(s) of difficulty walking, uveitis was a reasonable possibility. The reporter's causality for the event(s) of covid-19 was not provided. Causality: Glaucoma (glaucoma), Ill feeling (malaise), Tissue adhesion (adhesion), Pain localised (pain): Causality as per reporter (drug/vaccine): not related, Difficulty in walking (gait disturbance), Uveitis (uveitis) Causality as per reporter (drug/vaccine): probable, Covid-19 (covid-19) Causality as per reporter (drug/vaccine): not reported.  The reporter's assessment of the causal relationship of "glaucoma", "uveitis", "difficulty in walking", "tissue adhesion", "pain localised" and "ill feeling" with the suspect product(s) 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.  Follow-up attempts are completed. No further information is expected.; Sender's Comments: Based on the information in the case report and a plausible temporal relationship, 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.