Sex: F
Vaccine: COVID19, FLUX
Symptoms: Immunisation, Nausea, Pyrexia, Respiratory disorder, Suspected COVID-19
Clinical narrative: felt like had covid; felt like had covid; Anemia; Respiratory disorder/respiratory seemed to be getting worse; Fatigue; Appetite lost; Nausea; Fever; booster; Drug effect incomplete/methotrexate had not kicked in full; This is a solicited report from a Non-Interventional Study (FACILITATED COLLECT) based on information received by Pfizer from Company, manufacturer control number: 21K-163-4128894-00 from a contactable consumer (patient). A 77-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: unspecified), via intramuscular route of administration on an unspecified date in 2021 as DOSE 3 (BOOSTER), SINGLE for COVID-19 immunization; methotrexate sodium, route of administration, start and stop date, batch/lot number and dose were not reported for an unspecified indication and upadacitinib (RINVOQ), route of administration, start and stop date, batch/lot number and dose were not reported for rheumatoid arthritis. Medical history included Rheumatoid arthritis. It was unknown if she was enrolled in a covid-19 vaccine trial. Concomitant medication(s) included influenza vaccine (INFLUENZA VACCINE) taken for an unspecified indication, start and stop date were not reported. Historical vaccine included first and second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: unspecified), via unspecified route of administration on an unspecified date in 2021 as dose 1, single and dose 2, single respectively for COVID-19 immunization. On unknown dates in 2021, the patient experienced anemia, methotrexate had not kicked in full, respiratory getting worse, had Pfizer booster and had a light fever, nausea and fatigue/felt like had covid and loss of appetite. The patient reported that her blood work showed anemia. She had been on methotrexate for about three months and it had not kicked in fully (drug effect incomplete). Physician told it was about fifty percent. Her hands were doing better that she had been in hands therapy. Her respiratory seemed to be getting worse. Day two she felt like she had covid and the fourth day she felt better but still had Loss of appetite and fatigue. She also got the flu shot. The patient underwent lab tests and procedures which included blood test: anemia on an unspecified date in 2021. The action taken in response to the event(s) for methotrexate sodium and upadacitinib was unknown. The clinical outcome for the events was recovered for anemia, nausea and fever on an unspecified date in 2021, not recovered for Respiratory disorder/respiratory seemed to be getting worse, fatigue and appetite lost, recovering for felt like had covid and unknown for drug effect incomplete/methotrexate had not kicked in full.  The reporter's causality for all the event(s) with rinvoq (upadacitinib) was no reasonable possibility except for the event(s) of drug effect incomplete/methotrexate had not kicked in full with Rinvoq (upadacitinib) was a reasonable possibility and for event, felt like had covid, the reporter causality assessment was not provided at the time of report, since no determination has been received, the case is managed based on the company causality assessment. The reporter's causality for all the event(s) with methotrexate sodium was not reported and for event, felt like had covid, the reporter causality assessment was not provided at the time of report, since no determination has been received, the case is managed based on the company causality assessment. The reporter's causality for all the event(s) with BNT162B2 was not reported for events, except possible for fatigue, appetite lost, fever, nausea and for event, felt like had covid, the reporter causality assessment was not provided at the time of report, since no determination has been received, the case is managed based on the company causality assessment.  No follow-up attempts are needed. No further information is expected.; Sender's Comments: Based on the available information in the case and considering drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of reported events of Suspected Covid-19, Drug ineffective, Fatigue, Decreased appetite, Nausea and Fever cannot be completely excluded. However, there is no reasonable possibility to consider a causal association between the suspect product BNT162B2, and the reported events of Anaemia, Respiratory disorder and Therapeutic product effect incomplete assessed as unrelated. 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.