Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Nasal congestion, Pain, Pain assessment, Pain in extremity, Strabismus
Clinical narrative: This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (Not available). The reporter is the patient. Other Case identifier(s): 21K-163-3973435-00 (Company). A 56 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date 11May2021 (Batch/Lot number: unknown) at the age of 56 years as dose 2, single for covid-19 immunisation; adalimumab (HUMIRA), first regimen subcutaneous from 05May2021 (Batch/Lot number: unknown) to Nov2021 at 40 mg (40 mg [citrate free (40 mg,1 in 14 d)]) and second regimen subcutaneous since Nov2021 (ongoing) (Batch/Lot number: unknown) at 40 mg (40 mg [citrate free (40 mg,1 in 14 d)]) for ankylosing spondylitis. Relevant medical history included: "Not sleeping well" (unspecified if ongoing); "Pain in left shoulder" (unspecified if ongoing); "Low back pain with prolonged standing" (unspecified if ongoing); "Asthma" (unspecified if ongoing); "Inflammation" (unspecified if ongoing); "Difficulty putting socks in" (unspecified if ongoing); "Bending forward from waist to pick up a pen" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), administration date: 20Apr2021, when the patient was 55 years old, for Covid-19 Immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "COVID-19"; DRUG INEFFECTIVE (non-serious) with onset 2021, outcome "unknown", described as "Lack of drug effect/not sure if humira was working"; JOINT RANGE OF MOTION DECREASED (non-serious) with onset 2021, outcome "unknown", described as "Joint range of motion decreased/difficult to bend forward at waist to pick up a pen from the floor without an aid"; MOBILITY DECREASED (non-serious) with onset 2021, outcome "unknown", described as "Mobility decreased/reach up to a high shelf without help/unable to look over shoulder without turning body"; DYSSTASIA (non-serious) with onset 2021, outcome "unknown", described as "Difficulty in standing/some difficulty standing unsupported for 10 minutes without discomfort"; FEELING ABNORMAL (non-serious) with onset May2021, outcome "unknown", described as "Foggy feeling in head/brain fog"; LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (non-serious) with onset 2021, outcome "unknown", described as "impossible to get up from an armless chair unassisted/off floor/unable to climb 12 to 15 steps without handrail/difficulty doing full day activities/unable to do physically demanding activities"; DRY EYE (non-serious) with onset May2021, outcome "unknown", described as "Dry eyes"; STRABISMUS (non-serious) with onset May2021, outcome "unknown", described as "had to squint when reading"; CONTUSION (non-serious) with onset May2021, outcome "unknown", described as "Bruising/bruising on body not necessarily at injection site/bruise on stomach that had not gone away but increased in size"; ARTHRALGIA (non-serious) with onset May2021, outcome "not recovered", described as "pain in left Shoulder that wakes up at night that needs to switch positions while laying down"; BACK PAIN (non-serious) with onset May2021, outcome "recovered", described as "low back pain/described as burning pain/rates pain as 10/10 by end of day if sitting at work for 8 hours/standing for long period/an hour while cooking"; PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "not recovered", described as "pain from hips to ankles"; PAIN (non-serious) with onset May2021, outcome "recovered", described as "pain in legs worsened"; CHEST DISCOMFORT (non-serious) with onset 2021, outcome "unknown", described as "pressure in chest"; MUSCULOSKELETAL PAIN (non-serious) with onset 2021, outcome "not recovered", described as "pain in buttocks"; NASAL CONGESTION (non-serious), outcome "recovering", described as "stuffy nose"; VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "arm was sore after vaccine with humira (adalimumab)". The patient underwent the following laboratory tests and procedures: blood test: (2021) unknown results; laboratory test: (2021) inflammation improved; pain assessment: (2021) 10/10. The action taken for adalimumab was dosage not changed.  Suspect drug reported as PFIZER BIONTECH COVID-19 VACCINE(TOZINAMERAN)(TOZINAMERAN). on 19Jul2021, received updates to event information, reporter opinion of causality, suspect drug information, narrative description and medical history. the event of "headache" was added. on 01Sep2021, received updates to event information, reporter opinion of causality, suspect drug information, laboratory/diagnostic procedures, narrative description and medical history. the event of "difficult to get up from an armless chair without hands/get up off floor without help/unable to climb 12 to 15 steps without handrail" was amended to "impossible to get up from an armless chair unassisted /get up off floor without help/unable to climb 12 to 15 steps without handrail". the event of "bruise on stomach that had not gone away but increased in size" was amended to "bruisiig on body not necessarily at injection site/bruise on stomach that had not gone away but increased in size". the event of "pain in left shoulder" was amended to "pain in left shoulder that wakes up at night that needs to switch positions while laying down". on 18Nov2021, received updates to medical history, event information, reporter opinion of causality, suspect drug information, laboratory/diagnostic procedures and narrative description. the events of "pain from hips to ankles", "cough", "pressure in chest", "pain in right leg", "pain in buttocks" and "not sure if humira was working" were added. on 24Nov2021, received updates to event information, reporter opinion of causality, suspect drug information, laboratory/diagnostic procedures and narrative description. the events of "covid", "stuffy nose" and "arm was sore after vaccine" were added. the events of "pain in right leg", "cough" and "headache" were removed.  The reporter's assessment of the causal relationship of the events: Joint range of motion decreased, Mobility decreased , Difficulty in standing, Activities of daily living impaired , Foggy feeling in head , Squint, Dry eyes , Bruising, Shoulder pain, Low back, Pain worsened, Pain of lower extremities, Chest pressure, Buttock pain ,Lack of drug effect ,COVID-19 ,Nasal congestion and headache with the suspect product 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. The reporter considered "arm was sore after vaccine with humira (adalimumab)" related to bnt162b2. The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of the reported events Joint range of motion decreased, Mobility decreased , Difficulty in standing, Activities of daily living impaired , Foggy feeling in head , Squint, Dry eyes , Bruising, Shoulder pain, Low back, Pain worsened, Pain of lower extremities, Chest pressure, Buttock pain ,Lack of drug effect ,Vaccination site pain ,Nasal congestion and headache cannot be excluded Based on plausible dose -event relationship post vaccination and no other alternate explanation the causal role of BNT162B2 cannot be excluded for the reported LOE events.