Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Dyspnoea, Headache, Inflammatory marker increased, Investigation
Clinical narrative: Inflammatory marker increased; Vaccination adverse reaction; Throat inflammation; Difficulty breathing; Headache; Stomach pain; Left arm pain; FACILITATED COLLECT  This is a non-interventional study report from the marketing program received from a non-contactable consumer (patient) based on information received by Pfizer from via Manufacturer(manufacturer control number: 21K-131-3985481-00) .  A 62-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 intramuscular on an unspecified date (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous from 08Jan2020 (Batch/Lot number was not reported) and ongoing, at 40 mg/0.4 ml for rheumatoid arthritis  .  Medical history included rheumatoid arthritis from an unknown date and unknown if ongoing.     The patient's concomitant medications were not reported.  The patient experienced throat inflammation (pharyngeal swelling) (medically significant) on May2021 with outcome of unknown , difficulty breathing (dyspnoea) (non-serious) on May2021 with outcome of unknown , headache (headache) (non-serious) on May2021 with outcome of unknown , stomach pain (abdominal pain upper) (non-serious) on May2021 with outcome of unknown , left arm pain (pain in extremity) (non-serious) on May2021 with outcome of unknown , inflammatory marker increased (inflammatory marker increased) (non-serious) on Jun2021 with outcome of unknown , vaccination adverse reaction (vaccination complication) (non-serious) on May2021 with outcome of unknown.  The patient underwent lab tests and procedures which included investigation: inflammatory marker increased  on Jun2021  .  The action taken in response to the event(s) for for adalimumab was dose not changed.  Therapeutic measures were taken as a result of the events. The clinical course was reported as follows: a 62 year old female with  events of non-serious High Inflammation Levels, Reaction To Covid Vaccine, Throat Inflammation, Difficulty Breathing, Headache, Stomach Pain and Left Arm Pain with Humira 40MG/0.4ML (Adalimumab) and  COVID-19 Vaccine manufactured by Pfizer Biontech. The patient had a relevant medical history of Rheumatoid Arthritis.In May2021, the patient experienced Reaction to Covid Vaccine, Throat Inflammation, Difficulty Breathing, Headache, Stomach Pain And Left Arm Pain. In Jun2021, the patient experienced High Inflammation Levels. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Primary reporter did not have the lot number information, because the packaging was discarded.The patient was treated with Methotrexate. The reporter's causality for the event Inflammatory marker increased vs Humira was not provided. The reporter's  causality for the other events vs Humira was :no reasonable possibility. The reporter's causality for the event  Inflammatory marker increased vs bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) was not reported .The reporter's  causality for the other event(s) vs bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE)  was : probable.  The reporter's assessment of the causal relationship of the events Inflammatory marker increased 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.  Information on the lot/batch number has been requested.; Sender's Comments: Based on the current available information and a possible contributory role of the suspect product BNT162B2 to the development of events pharyngeal swelling, dyspnoea, headache, abdominal pain upper, pain in extremity, inflammatory marker increased and vaccination site complication 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 RAs, Ethics Committees, and Investigators, as appropriate.