Age: 45.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Pruritus, Pyrexia, Tinnitus
Clinical narrative: Cramping of fingers; Burning hands; Itching on hand palms/itching on feet; Painful L arm; Blood pressure high; Weakness in left side; Chills; Ears ringing; Flu like symptoms; Fever; This is a solicited report from a non-contactable consumer (patient). A 45-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; solution for injection; Lot Number: EP7533) via an unspecified route of administration on 07Apr2021 (at the age of 45-years-old) as a single dose for COVID-19 immunization and adalimumab (HUMIRA; solution for injection in pre-filled pen; strength: 40mg/0.4mL) subcutaneously from 2016 and ongoing at 40mg, weekly (CF, 40mg, 1 in 1 week) for moderate to severe rheumatoid arthritis and ulcerative colitis. Medical history included megaloblastic anemia, allergic to aspirin, allergic to penicillin, allergic to shellfish, allergic to tramadol, rheumatoid arthritis, ulcerative colitis, abstains alcohol, acid reflux and allergy all from unspecified dates and unspecified if ongoing. The patient had no tobacco use. Concomitant medications included methotrexate taken for an unspecified indication on unspecified dates, folic acid taken for an unspecified indication on unspecified dates, dexlansoprazole (DEXILANT) taken for an unspecified indication on unspecified dates, dexlansoprazole (DEXILANT) taken for acid reflux on unspecified dates, montelukast sodium (SINGULAIR) taken for an unspecified indication on unspecified dates, cetirizine hydrochloride (CETIRIZINE) taken for allergy on unspecified dates, fluticasone propionate (FLONASE) taken for an unspecified indication on unspecified dates and salbutamol (ALBUTEROL) taken for an unspecified indication on unspecified dates. On 07Apr2021 the patient experienced chills, ears ringing, flu like symptoms and fever; on 22Apr2021 the patient experienced weakness in left side, painful L (left) arm and blood pressure high; on 25Apr2021 the patient experienced burning hands and Itching on hand palms/itching on feet and on an unspecified date the patient experienced cramping of fingers. The events were all assessed as non-serious. The action taken in response to the events for adalimumab was dose not changed. The clinical outcomes of the events chills, ears ringing, flu like symptoms and fever were recovered/resolved on 07Apr2021; weakness in left side, painful L arm, blood pressure high, burning hands and Itching on hand palms/itching on feet were recovered/resolved on an unspecified date and cramping of fingers was not recovered/not resolved.   The reporter's causality for the events chills, weakness in left side, Itching on hand palms/itching on feet, burning hands, ears ringing, flu like symptoms, fever, painful L arm, blood pressure high and cramping of fingers with adalimumab was no reasonable possibility.   The reporter's assessment of the causal relationship of the events 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 on the company causality assessment.  Information on Lot/Batch number was available. Additional information has been requested.; Sender's Comments: Based on the information provided, a causal association between suspect drug and the reported events cannot be completely excluded considering a temporal relationship. Case will be reassess once additional information becomes 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 RAs, Ethics Committees, and Investigators, as appropriate.