Age: 70.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Pyrexia, SARS-CoV-2 test
Clinical narrative: COVID-19; COVID-19; Difficulty in standing; Unable to walk; Chest congestion; Slight fever; This is a solicited report from a contactable consumer (patient)  based on the information received by Pfizer from a company (MFR Control No. 21K-163-4061421-00). Solicited report by a consumer of a 70 year old female with events of COVID and non-serious could not stand or walk with HUMIRA (ADALIMUMAB). On 05Feb2021 (at the age of 70-year-old), the patient received 1st dose COVID-19 Vaccine manufactured by Pfizer intramuscularly at single dose and on 26Feb2021 (at the age of 70-year-old), the patient received 2nd dose COVID-19 Vaccine manufactured by Pfizer intramuscularly at single dose, for COVID-19 immunization. On an unspecified date the patient received HUMIRA (ADALIMUMAB, Solution for injection in pre-filled syringe), Subcutaneous for Moderate to severe rheumatoid arthritis. Concomitant Drugs were Not Reported. The patient had no known allergies and medical history included moderate to severe rheumatoid arthritis. On an unknown date, the patient experienced could not stand or walk with. In 2021, the patient experienced COVID. PFIZER BIONTECH COVID-19 VACCINE was also considered suspect. The patient had been hospitalized with covid for three week and medical rehab for two weeks. She had chest congestion, slight fever and she could not stand or walk. She had catheter. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. In 2021, the COVID resolved. The outcome of other events was unknown.   Causality for HUMIRA (ADALIMUMAB) The reporter's causality for the event(s) of COVID with HUMIRA(ADALIMUMAB) was no reasonable possibility. The reporter's causality for the event(s) of could not stand or walk unknown onset was not provided. Company's opinion is that there is no reasonable possibility that the events of COVID, could not stand or walk unknown onset et are related to HUMIRA (ADALIMUMAB).  Change History On 12Oct2021, received updates to patient demographics, event information, reporter opinion of causality, company alternative etiology, suspect drug information, narrative description and medical history.  Causality for PFIZER BIONTECH COVID-19 VACCINE: The reporter's causality for the event(s) of COVID with PFIZER BIONTECH COVID-19 VACCINE was Probable. The reporter's causality for the event(s) of could not stand or walk unknown onset was not provided.  Pfizer Statement: The reporter's assessment of the causal relationship of the events difficulty in standing, unable to walk, chest congestion and slight fever with the suspect product PFIZER BIONTECH COVID-19 VACCINE 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.; Sender's Comments: Based on the information currently available, a possible contributory role of the suspect drug to the reported events "COVID-19, Difficulty in standing, Unable to walk, Chest congestion, Slight fever" cannot be completely excluded based on temporal association.   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 identifies as part of this review, as well as any appropriate action in response, will be promptly notifies to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.