Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Keratoconus, Rash
Clinical narrative: Cataract in left eye; Keratoconus; flares; Connective tissue disease; Tired; Bruises; Coughing; Broke out with spots on legs; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 22K-163-4270331-00.  A 66 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date 01Nov2021 (Batch/Lot number: unknown) at the age of 66 years as dose 3 (booster), single, intramuscular, administration date 15Feb2021 (Batch/Lot number: unknown) as dose 2, single and intramuscular, administration date 28Jan2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Batch/Lot number: unknown) at unk (cf) for uveitis, rheumatoid arthritis. Relevant medical history included: "cataract surgery in left eye" (unspecified if ongoing), notes: She had cataract surgery in left eye. The patient's concomitant medications were not reported. The following information was reported: CATARACT (medically significant), outcome "recovering", described as "Cataract in left eye"; KERATOCONUS (medically significant), outcome "unknown", described as "Keratoconus"; CONDITION AGGRAVATED (non-serious), outcome "unknown", described as "flares"; CONNECTIVE TISSUE DISORDER (non-serious), outcome "unknown", described as "Connective tissue disease"; FATIGUE (non-serious), outcome "unknown", described as "Tired"; CONTUSION (non-serious), outcome "unknown", described as "Bruises"; COUGH (non-serious), outcome "not recovered", described as "Coughing"; RASH (non-serious) with onset 2021, outcome "unknown", described as "Broke out with spots on legs". The action taken for adalimumab was unknown.  Causality for Humira (Adalimumab): The reporter's causality for the event(s) of cataract in left eye, connective tissue disease, tired, coughing, Bruises and broke out with spots on legs with Humira (Adalimumab) was no reasonable possibility. The reporter's Causality for the event(s) of flares with humira (adalimumab) was a reasonable possibility. The reporter's Causality for the event(s) of keratoconus was not provided. Opinion is that there is no reasonable possibility that the events of cataract in left eye. Keratoconus and broke out with spots on legs are related to Humira (adalimumab). Opinion is that the Events of flares, connective tissue disease, tired, coughing and bruises are not assessable.  The reporter's assessment of the causal relationship of the events with the Pfizer Biontech Covid-19 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.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the Limited information available and close temporal association, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events. The case will be reassessed once new information is available 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.