Age: 57.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Pain assessment, Poor quality sleep, Skin fissures, Thirst, Throat irritation
Clinical narrative: scratchy  throat; finger tips cracking; disc issues in neck; not sleeping well; Anxiety; left-sided chest pressure; Pain; tired; Thirst; Vertigo; Type 2 diabetes mellitus; This is a solicited report based on information received by Pfizer from AbbVie (Mfr. Control No.: 20K-163-3636731-00). A contactable consumer (patient) reported that a 57-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 intramuscular at age of 57 years on 17Mar2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation; adalimumab (Humira 40mg/0.4ml (40 milligram, solution for injection in pre-filled pen)), subcutaneous from 27Mar2020 (Batch/Lot number was not reported) to an unspecified date, at 40 mg, Citrate Free (40 mg,1 in 14 D), subcutaneous from an unspecified date (Batch/Lot number was not reported) and ongoing, at 40 mg, (40 Milliequivalents,1 in 14 D) for psoriatic arthritis. Medical history included cluster headache. Concomitant medication included methotrexate. The patient experienced type 2 diabetes mellitus in 2021, scratchy throat on an unspecified date, finger tips cracking on an unspecified date, tired on 17Mar2021, thirst on 17Mar2021, disc issues in neck on an unspecified date, not sleeping well on an unspecified date, anxiety on an unspecified date, vertigo on 2021, left-sided chest pressure on an unspecified date, pain on 06Apr2021. The clinical course details was as follows: patient with events of non-serious scratchy  throat, Finger tips cracking , voice sound as patient was going to get a sinus infection/ may be sinus infection, sinus pain, swollen joints of finger, toes, Hands, wrist walking issue/problems in waling about, problems with Usual activities such as cutting, chopping food, cleaning/problems with dressing, took longer, very tired, sore Arm after covid vaccine, extremely thirsty and very tired immediately after covid vaccine, extremely thirsty and tired immediately after thirsty covid vaccine, disc issues in neck, not sleeping well, stiff joint, anxiety, vertigo, type 2 diabetes, stomach tender at injection site, left-sided chest pressure, tender joints of fingers, toes, hands, wrists, sinus infection and pain with humira 40mg/0.4ml (adalimumab). On unknown dates, the patient experienced scratchy throat, finger tips cracking, voice sound as patient was going to get a sinus infection/ maybe sinus infection, sinus pain, swollen joints of fingers, toes, hands, wrists, walking issues/problems in walking about, problems with usual activities such as cutting, chopping food, cleaning/problems with dressing, took longer, disc issues in neck, not sleeping well, stiff joint, anxiety, stomach tender at injection site, left-sided chest pressure and tender joints of fingers, toes, hands,wrists. on 04Nov2020, the patient experienced sinus infection. on 14Nov2020, the patient experienced sinus infection. in Nov2020, the sinus infection resolved. on 22Dec2020, the patient experienced voice sound as patient was going to get a sinus infection/ maybe sinus infection. in 2020, the sinus infection resolved. in 2021, the patient experienced vertigo and type 2 diabetes. On 17Mar2021, the patient experienced extremely thirsty and very tired immediately after covid vaccine and extremely thirsty and tired immediately after first covid vaccine. on 06Apr2021, the patient experienced pain. on 07Apr2021, the patient experienced very tired. on 03Sep2021, the patient experienced sore arm after covid vaccine. in 2021, the extremely thirsty and very tired immediately after covid vaccine resolved. pfizer biontech covid-19 vaccine (tozinameran) was also considered suspect. It was unknown if patient was enrolled in a covid-19 vaccine trial. on 17Mar2021, patient received first dosecovid-19 vaccine manufactured by pfizer/biontech, lotnumber unknown, expiration date unknown. on 07Apr2021, patient received second dose covid-19 vaccine manufactured by pfizer/biontech, lot number unknown, expiration date unknown. on 03Sep2021, patient received third dose covid-19 vaccine manufactured by pfizer/biontech, lot number unknown, expiration date unknown. The patient was treated with clobetasol. causality for humira 40mg/0.4ml(adalimumab) The reporter's causality for the event(s) of scratchy throat, very tired, sore arm after covid vaccine, extremely thirsty and very tired immediately after covid vaccine and extremely thirsty and tired immediately after first covid vaccine with humira 40mg/0.4ml(adalimumab) was no reasonable possibility. The reporter's causality for the event(s) of finger tips cracking, voice sound as patient was going to get a sinus infection/maybe sinus infection unknown onset, sinus pain, swollen joints of fingers, toes, hands, wrists, walking issues/problems in walking about, problems with usual activities such as cutting, chopping food, cleaning/problems with dressing, took longer, not sleeping well, stiff joint, anxiety, vertigo, type 2 diabetes, stomach tender at injection site, left-sided chest pressure, tender joints of fingers, toes, hands, wrists and pain was not provided. the reporter's causality for the event(s) of disc issues in neck, sinus infection onset 04Nov2020, sinus infection onset 14Nov2020 and voice sound as patient was going to get a sinus infection/ maybe sinus infection onset 22Dec2020 with humira 40mg/0.4ml(adalimumab) was a reasonable possibility. Change history: On 11Jan2021, received updates to medical history, event information, reporter opinion of causality, suspect drug information and narrative description. the events of "sinus pain", stomach tender at injection site, swollen joints, stiff joint, tender/pain joint, walking issues, problems with usual activities and anxiety were added. On 11Feb2021, received updates to patient demographics, event information, reporter opinion of causality, suspect drug information and narrative description. the event of "sinus infection" was added. On 06Apr2021, received updates to patient demographics, event information, reporter opinion of causality, suspect drug information, concomitant drug information, treatment drug information, laboratory/diagnostic procedures and narrative description. the events of finger tips cracking, vertigo, type 2 diabetes and pain were added. the event of swollen joints was amended to swollen joints of fingers, toes, hands, wrists. the event of walking issues was amended to walking issues/problems in walking about. the event of problems with usual activities was amended to problems with usual activities such as cutting, chopping food, cleaning/problems with dressing, took longer. the event of tender/pain joint was amended to tender joints of fingers, toes, hands, wrists. On 23Sep2021, received updates to event information, reporter opinion of causality, suspect drug information and narrative description. the events of very tired, sore arm after covid vaccine, extremely thirsty and very tired immediately after covid vaccine, extremely thirsty and tired immediately after first covid vaccine and disc issues in neck were added. Relevant laboratory & other diagnostic tests: 06Apr2021 pain scale: 4 to 5 out of 10. The action taken in response to the events, for adalimumab was dose not changed. The outcome of tired was recovered in 2021, of throat irritation and thirst was recovering, of finger tips cracking and pain was not recovered, other events was unknown.  The reporter's assessment of the causal relationship of the event with the suspect product bnt162b2 was not provided at the time of this report. Since no determination has been received, the case is managed based the company causality assessment.  The lot number for BNT162b2 was not provided and will be requested during follow up.; Sender's Comments: Limited information of event onset dates, HbA1c values, family history and other concomitant medications and steroid therapy preclude a comprehensive causality assessment of event type 2 diabetes mellitus and unlikely causal association with bnt162b2    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