Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, Hip arthroplasty, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: Moderna covid-19 vaccine (Elasomeran) and Pfizer BioNTech Covid-19 Vaccine (Tozinameran) were also considered suspect.; Hip replacement; patient caught covid and did not feel good for some days; patient caught covid and did not feel good for some days; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4509127-00.  A 78-year-old male patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) intramuscular for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown), all intramuscular for covid-19 immunisation; upadacitinib (RINVOQ), first regimen (Lot number: 1163234) and second regimen since 2022 (ongoing) (Lot number: 1163234), all oral for rheumatoid arthritis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jun2022, outcome "recovered" (2022) and all described as "patient caught covid and did not feel good for some days"; HIP ARTHROPLASTY (medically significant) with onset 03Aug2022, outcome "recovering", described as "Hip replacement"; INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "unknown", described as "Moderna covid-19 vaccine (Elasomeran) and Pfizer BioNTech Covid-19 Vaccine (Tozinameran) were also considered suspect.". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jun2022) Positive, notes: in Jun2022, the patient experienced COVID. The action taken for upadacitinib was dosage not changed. Therapeutic measures were taken as a result of hip arthroplasty.  The reporter considered "patient caught covid and did not feel good for some days", "moderna covid-19 vaccine (elasomeran) and pfizer biontech covid-19 vaccine (tozinameran) were also considered suspect." and "hip replacement" related to BNT162b2. The reporter's causality for the event(s) of hip replacement and Covid with Rinvoq (Upadacitinib) was not reported.  The reporter's causality for the event(s) of hip replacement and Covid was not provided. Agency's opinion is that there is no reasonable possibility that the events of hip replacement and Covid are related to Rinvoq (Upadacitinib).  Clinical information: In Jun2022, patient caught covid and did not feel good for some days. He recovered and was feeling better. He still had some trouble getting around. He was off of Rinvoq for a while per physician order due to surgery but in 2022 he was back on Rinvoq. He was doing physical therapy three times a week. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: As there is limited information in the case provided, the causal association between the reported events drug ineffective, covid-19 and interchange of vaccine products with the suspect drug BNT162B2 cannot be excluded. Based on the current available information, the reported event hip arthroplasty is more likely to be associated to underlying medical condition or inter-current condition and unlikely to be related to the suspect product BNT162B2. The case will be reassessed once new information is available.