Sex: F
Vaccine: COVID19
Symptoms: Anaemia, Fall, Mobility decreased, Osteoarthritis, Retching
Clinical narrative: Vertigo/not turned around or back up without falling; was not able to move because legs gave out; Osteoarthritis; Anemic; Bad reaction to booster vaccination; dry heaving; Vertigo/not turned around or back up without falling; fall in the bathroom; This is a solicited report from a contactable consumer (patient) via a Non-Interventional Study based on information received by Pfizer from Regulatory Authority, manufacturer control number: 21K-163-4115000-00.   A 72-year-old female patient received bnt162b2 (PFIZER BIONTECH COVID-19 VACCINE, solution for injection), dose 3 intramuscular on 2021 (Batch/Lot number was not reported) as dose 3 (booster), single for COVID-19 immunisation; upadacitinib (RINVOQ), oral from 14Apr2021 (Batch/Lot number was not reported) and ongoing, at unspecified dose and frequency for moderate to severe rheumatoid arthritis. Medical history included Thyroid cancer removed in 1976, COVID-19 from Dec2020 to an unknown date and tobacco use: smoker from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. It was unknown if she was enrolled in a COVID-19 Vaccine Trial. The patient took the first and second dose of BNT162B2 on unspecified dates for COVID-19 immunisation. She received first dose and second dose of COVID-19 vaccine manufactured by Pfizer/BioNTech. She received booster Vaccine manufactured by Pfizer/BioNTech. In 2021, the patient experienced two knee replacements, two hip replacements, vertigo/not turned around or back up without falling, fall in the bathroom/was not able to move because legs gave out, was dry heaving, osteoarthritis, anemic and bad reaction to booster vaccination of Pfizer with RINVOQ (upadacitinib). In Jul2021, the patient experienced vertigo/not turned around or back up without falling. In 2021, the vertigo/not turned around or back up without falling and vertigo/not turned around or back up without falling resolved. Pfizer BioNTech covid-19 vaccine (tozinameran) was also considered suspect. Clinical course details: In Jul2021, the patient developed vertigo and had been on Meclizine since then. The vertigo was under control as of 08Oct2021. She had the booster vaccination for Pfizer and had a bad reaction to it. She fell in the bathroom and was not able to move for six hours because her legs gave out on her and was dry heaving. Since being on upadacitinib (RINVOQ) had not had any flare ups. Events were reported as serious Other medically important condition. The outcome of the event Vertigo and not turned around or back up without falling - 'falling' was recovered in 2021, for the other events was unknown.  Causality for RINVOQ (UPADACITINIB): The reporters causality for the event(s) of two knee replacements, two hip replacements, fall in the  bathroom/was not able to move because legs gave out, was dry heaving onset in 2021, fall in the bathroom/was not able to move because legs gave out, was dry heaving onset in 2021, osteoarthritis, anemic, bad reaction to booster vaccination of Pfizer and fall in the bathroom/was not able to move because legs gave out, was dry  heaving onset in 2021 was not provided. the reporter's causality for the event(s) of vertigo/not turned around or back up without falling onset in 2021 and vertigo/not turned around or back up without falling onset in Jul2021 with rinvoq (upadacitinib) was no reasonable possibility.  Regulatory Authority opinion is that there is no reasonable possibility that the events of two knee replacements, two hip  replacements, vertigo/not turned around or back up without falling onset in 2021, vertigo/not turned around or  back up without falling onset in Jul2021, fall in the bathroom/was not able to move because legs gave out,was dry heaving onset in 2021, fall in the bathroom/was not able to move because legs gave out,was dry heaving  onset in 2021, osteoarthritis, anemic, bad reaction to booster vaccination of pfizer and fall in the bathroom/was not able to move because legs gave out,was dry heaving onset in 2021 are related to  rinvoq (upadacitinib).  Causuality for RINVOQ of Total knee replacement (Knee arthroplasty), Hip total replacement (Hip arthroplasty), Fall (Fall), Mobility decreased (Mobility decreased), Osteoarthritis (Osteoarthritis), Anemic (Anaemia), Vaccination adverse reaction (Vaccination complication), Dry heaves (Retching). Causality as per reporter (Drug/Vaccine): Not Reported,Causality as per Mfr.(Drug/Vaccine): No reasonable possibility. Causuality for RINVOQ of Falling (Fall), Vertigo (Vertigo). Causality as per reporter (Drug/Vaccine): No reasonable possibility. Causality as per Mfr.(Drug/Vaccine): No reasonable possibility. Causuality for BNT162B2 of Vaccination adverse reaction (Vaccination complication) Causality as per reporter (Drug/Vaccine): Possible, for the rest of the events was not reported.  No follow-up attempts are needed; information about Lot/Batch number cannot be obtained. No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association between the event fall, vertigo, Mobility decreased , Osteoarthritis, Vaccination adverse reaction, anaemia, Dry heaves,  and the suspect vaccine COMIRNATY cannot be 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.