Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Ocular discomfort, Road traffic accident
Clinical narrative: Discomfort of eyes; Fatigue; Dry eyes; Pain in eyes; Nausea; Back disorder; Automobile accident; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP and Other HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 21K-163-4126504-00.  A 60 year-old female patient received bnt162b2 (BNT162B2), intramuscular (Batch/Lot number: unknown) at the age of 60 years as dose number unknown, single for covid-19 immunization; adalimumab (HUMIRA), subcutaneous (Batch/Lot number: unknown) at 40 mg weekly (40 mg, weekly (citrate free)) for uveitis. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: BACK DISORDER (medically significant), outcome "unknown", described as "Back disorder"; ROAD TRAFFIC ACCIDENT (non-serious) with onset Jun2021, outcome "unknown", described as "Automobile accident"; OCULAR DISCOMFORT (non-serious), outcome "unknown", described as "Discomfort of eyes"; FATIGUE (non-serious), outcome "recovered", described as "Fatigue"; DRY EYE (non-serious), outcome "not recovered", described as "Dry eyes"; EYE PAIN (non-serious), outcome "unknown", described as "Pain in eyes"; NAUSEA (non-serious), outcome "recovered", described as "Nausea". The action taken for adalimumab was unknown. Therapeutic measures were taken as a result of ocular discomfort, dry eye, eye pain.  Additional information: In Jun2021, patient was in automobile accident and had surgery and was in recovery from her surgery. She took unknown steroid injection in back on 18Oct2021. She had dry eyes. She had pain and discomfort in eyes and she used medication called Sustain for those symptoms. She experienced fatigue and nausea after her covid-19 vaccinations. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Patient received COVID-19 Vaccine manufactured by Pfizer BioNTech. Adverse event information provided by patient not related to covid vaccine.   Causality for HUMIRA 40MG/0.4ML(ADALIMUMAB) The reporter's causality for the event(s) of Back disorder, Discomfort in eyes and pain in eyes was not provided. The reporter's causality for the event(s) of Back disorder, Discomfort of eyes, Fatigue, Dry eyes, Pain in eyes and Nausea with HUMIRA 40MG/0.4ML(ADALIMUMAB) was no reasonable possibility. Agencies opinion is that there is no reasonable possibility that the events of Back disorder, Discomfort of eyes, Fatigue, Dry eyes, Pain in eyes and Nausea are related to HUMIRA 40MG/0.4ML(ADALIMUMAB). Change History On 19Nov2021, received updates to event information, reporter opinion of causality, company opinion of causality, company alternative etiology, suspect drug information, concomitant drug information and narrative description. The events of "Fatigue" and "Nasuea" were added. The event of "Back disorder" is now considered serious.  Causality for TOZINAMERAN vaccine was not provided.  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 information available in narrative the reported  events of Back disorder ,Automobile accident, , Fatigue, Dry eyes,  and Nausea  are assessed as related to suspected vaccine BNT162B2. However, the reported events of Discomfort of eyes and Pain in eyes are assessed as not related to suspected vaccine BNT162B2 and more likely due to ongoing medical condition of uveitis. 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.