Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Influenza like illness, Knee arthroplasty
Clinical narrative: tired; got left knees replaced; Knee joint pain; Flu like symptoms/flu like symptoms after all covid shots/covid vax reactions; fever; chills; body aches/ General body pain; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 21K-163-3734410-00.  A 53-year-old female patient received BNT162b2 (BNT162B2), on 02Feb2021 as dose 1, single (Batch/Lot number: unknown) and on 02Mar2021 as dose 2, single (Batch/Lot number: unknown) at the age of 53 years, all intramuscular for covid-19 immunisation; upadacitinib (RINVOQ), (Batch/Lot number: unknown), oral for rheumatoid arthritis; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 01Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown) intramuscular for covid-19 immunisation. The patient's relevant medical history included: "COVID-19" (unspecified if ongoing), notes: The patient had COVID in Jan2021; "Dose:1, 2 Pfizer/Dose:3 Moderna" (unspecified if ongoing), notes: Dose:1, 2 Pfizer/Dose:3 Moderna. There were no concomitant medications. The following information was reported: INFLUENZA LIKE ILLNESS (non-serious) with onset 2021, outcome "recovered", described as "Flu like symptoms/flu like symptoms after all covid shots/covid vax reactions"; ARTHRALGIA (medically significant) with onset 2021, outcome "unknown", described as "Knee joint pain"; PAIN (non-serious) with onset 2021, outcome "recovered", described as "body aches/ General body pain"; CHILLS (non-serious) with onset 2021, outcome "recovered"; PYREXIA (non-serious) with onset 2021, outcome "recovered", described as "fever"; KNEE ARTHROPLASTY (medically significant) with onset Jun2022, outcome "recovering", described as "got left knees replaced"; FATIGUE (non-serious), outcome "unknown", described as "tired". The action taken for upadacitinib was unknown.  Clinical information: On the unknown date, the patient experienced knee joint pain. In 2021, the patient experienced flu like symptoms after all Covid shots/ Covid vax reactions and fever, chills, body aches with Covid shots/ Covid vax reactions. In January 2021, the patient experienced COVID. On unknown dates, covid, flu like symptoms after all covid shots/covid vax reactions and fever, chills, body aches with covid shots/covid vax reactions resolved. Pfizer Biontech Covid-19 Vaccine (Tozinameran) and Moderna Covid-19 Vaccine (Elasomeran) were also considered suspect. The patient had COVID in Jan2021. She was very sick in bed for days with fever, body aches and was tired. She had same symptoms as having during Covid to all Covid vaccines and boosters. She was in bed with fever and body aches. She reported she cannot go up and down stairs due to knee joint pain and got left knees replaced in June 2022. She was recovering from full left knee replacement. The terms fever, body aches and tired were unified under Covid-19. It was unknown if patient was enrolled in a COVID-19 vaccine trial. Adverse event information provided by patient was related to COVID vaccine.   The reporter's assessment of the causal relationship of "got left knees replaced" and "tired" with the suspect product(s) 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.   The reporter considered "knee joint pain", "flu like symptoms/flu like symptoms after all covid shots/covid vax reactions", "fever", "chills" and "body aches/ general body pain" related to BNT162b2.  Causality for Rinvoq (Upadicitinib): The reporter's causality for the event (s) of flu like symptoms/flu like symptoms after all covid shots/covid vax reactions, knee joint pain, fever, chills, body aches was not provided.  Causality for Moderna COVID-19 Vaccine (ELASOMERAN) (ELASOMERAN): The reporter's causality for the event (s) of flu like symptoms/flu like symptoms after all covid shots/covid vax reactions, knee joint pain, like illness, fever, chills and body aches was possible.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.  Follow up (14Jul2022): This is a follow-up solicited report based on the information received by Pfizer. (Manufacturer Control No: 21K-163-3734410-00). A contactable consumer (Patient) reported that includes: New events (Influenza like illness, Pyrexia, Chills, pain, fatigue and knee arthroplasty), causality updated and clinical information added.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on temporal association, there is reasonable possibility of causal association between the Reported events fatigue, pyrexia, chills, influenza like illness, pain  and the suspect drug BNT162B2. Based on the current available limited information in the case provided, the causal association between the events knee replacement, arthralgia and the use of suspect product BNT162B2 cannot be fully 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.