Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Morning stiffness caused to drop things; Low Hemoglobin; Anemia; Low grade temperature; Fatigue; This is a solicited report from a contactable consumer (patient) via marketing program (FACILATED COLLECT) based on information received by Pfizer from, manufacturer control number: 21K-163-4116796-00.  Solicited report from a consumer of a 71 year old female with events of Low Haemoglobin and non-serious anaemia, morning stiffness caused to drop things and low grade temperature and fatigue following the covid vaccine with RINVOQ (UPADACITINIB). There was no reported medical history. On unknown dates, the patient experienced morning stiffness caused to drop things and low grade temperature and fatigue following the covid vaccine. In 2021, the patient experienced ANEMIA. On 21Jul2021, the patient experienced Low Haemoglobin. On an unknown date, low grade temperature and fatigue following the covid vaccine resolved. PFIZER BIONTECH COVID-19 VACCINE (TOZINAMERAN) was also considered suspect. Patient was anaemic for last few months in 2021. She also had morning stiffness that caused her to drop things. She had low grade temperature and fatigue for one day following the covid vaccine. On 21Jul2021, her haemoglobin was low and she got an iron infusion. Adverse events information provided by patient was related to COVID-19 vaccine. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. In Dec2020, patient received first dose COVID-19 vaccine manufactured by Pfizer/BioNTech. In Jan2021, patient received second dose COVID-19 vaccine manufactured by Pfizer/BioNTech. Causality for RINVOQ(UPADACITINIB) The reporter's causality for the event(s) of Low Haemoglobin and non-serious anaemia, morning stiffness caused to drop things and low grade temperature and fatigue following the covid vaccine. unknown onset and low grade temperature and fatigue following the covid vaccine  unknown onset was not provided. withheld opinion is that the events of Low Haemoglobin and anaemia are not assessable. withheld opinion is that there is no reasonable possibility that the events of morning stiffness caused to drop things and low grade temperature and fatigue following the covid vaccine unknown onset and low grade temperature and fatigue following the covid vaccine unknown onset are related to RINVOQ (UPADACITINIB). Relevant Laboratory & Other Diagnostic Tests 21Jul2021 HEMOGLOBIN: Low. Check all the appropriate to adverse reaction: other medical important condition. The action taken in response to the events for upadacitinib was unknown. The outcome of low grade temperature and fatigue was recovered on unknown date with duration of 1 day, of other events was unknown. Causality as per reporter for events low grade temperature and fatigue with BNT162B2 was possible.  The reporter's assessment of the causal relationship of the events Low Haemoglobin, anaemia, morning stiffness 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.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information provided and plausible temporal association, the causality between BNT162B2 and Haemoglobin decreased, Pyrexia, Fatigue, Anemia, Musculoskeletal stiffness  cannot be completely 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 regulatory authorities, Ethics Committees, and Investigators, as appropriate.