Sex: F
Vaccine: COVID19
Symptoms: Hypertension, Hyposmia, Joint swelling, Oral candidiasis, Oxygen saturation
Clinical narrative: Oral thrush; covid-19; covid-19; Pneumonia recurrent; Headache; Asthma; joint pain; weight gain; Blood pressure high; Lupus erythematosus; Oxygen saturation low; Joint swelling; Vertigo; Diminished sense of smell; Loss of taste; Wheezing; Gasping; her blood pressure was high and had fluctuated since then; This is a solicited report based on the information received by Pfizer from AbbVie Inc. (manufacturer Control Number: 20K-163-3384108-00) from a contactable consumer (patient). This is the first of two reports with events experienced under the first dose. The patient was a 54-year-old female. Solicited report by a consumer of a 54 year old female with events of lupus and non-serious headache, asthma, joint pain, weight gain, COVID-19, high blood pressure, oral thrush, low oxygen levels, recurrent pneumonia, joint swelling, vertigo, lost sense of smell, lost sense of taste, wheezing when breathing, gasping for air and after second covid vaccination experienced fever, achiness and fatigue with RINVOQ (UPADACITINIB). The patient had a relevant medical history of asthma, high blood pressure, tobacco user, pneumonia and lupus. On unknown dates (also reported as 2021), the patient experienced lupus, asthma, weight gain, high blood pressure and low oxygen levels. On 13May2020, the patient experienced headache. In 2021, the patient experienced joint pain, joint swelling, vertigo, lost sense of smell, lost sense of taste, wheezing when breathing, gasping for air and after second covid vaccination experienced fever, achiness and fatigue. In Jan2021, the patient experienced recurrent pneumonia. On 18Jan2021, the patient experienced COVID-19. In Feb2021, the patient experienced oral thrush. On 18Feb2021, the COVID-19 resolved. In Feb2021, the oral thrush and recurrent pneumonia resolved. In 2021, the joint pain, joint swelling and after second covid vaccination experienced fever, achiness and fatigue resolved. PFIZER BIONTECH COVID-19 VACCINE (TOZINAMERAN) was also considered suspect. Pneumonia was on and off symptom to the patient even before RINVOQ therapy. On 01Apr2020, she had a cough at night and difficulty catching her breath. That had been going on since 01Apr2020. On 13May2020, she had headache. She saw her lung specialist for that. She had asthma and the cold weather had caused her chest pains and also caused joint pain. She had gained weight. On 18Jan2021 she had rapid test as a precautionary measure because she works in a healthcare facility. The result was positive for COVID-19 but she was asymptomatic but advised by her physician to do self-quarantine with unspecified antibiotic treatment. She started having symptoms the following day wherein she went back to her physician and was given antibody infusion for five hours as an outpatient and also given Vitamin D3, Vitamin C and Zinc to treat COVID-19. She contracted COVID-19. She continued to have fever and low oxygen levels. Her Covid was lasted for a month. She was taken off RINVOQ for one and half months while recovering from COVID. As a result, she experienced joint pain and swelling. Then she came with pneumonia after getting COVID-19. Her lungs had been left in a state that makes her wheeze when breathing and gasping for air. She also had lupus. She had also gotten thrush. She reported her blood pressure was high and had fluctuated since then. She was not hospitalized when she had recurred Pneumonia, oral thrush, COVID-19, high fever, chest pain, and cough. The covid had left her with vertigo. She lost her sense of smell and taste, and still could not taste to the day of 11Sep2021. After her second COVID vaccination she experienced fever, achiness and fatigue. This was the only event that was associated with the covid vaccination. It was unknown if patient was enrolled in a COVID-19 vaccine trial. In 2021, patient received dose COVID-19 vaccine manufactured by Pfizer BioNTech. The patient was treated with NYSTATIN and PLAQUENIL. Patient recovered on 18Feb2021 from covid-19, recovered in Feb2021 from Pneumonia recurrent and Oral thrush, recovered in 2021 from joint pain, Joint swelling and Gasping, she had not recovered from Lupus erythematosus, asthma, weight gain, blood pressure high, oxygen saturation low, she was recovering from Headache, Vertigo, Diminished sense of smell, Loss of taste, Wheezing, outcome of the other mentioned event was unknown. Causality for RINVOQ(UPADACITINIB) The reporters causality for the event(s) of lupus, headache, asthma, weight gain, high blood pressure, low oxygen levels, vertigo, lost sense of smell, lost sense of taste, wheezing when breathing and gasping for air was not provided. The reporters causality for the event(s) of joint pain and joint swelling with RINVOQ(UPADACITINIB) was a reasonable possibility. The reporters causality for the event(s) of COVID-19, oral thrush, recurrent pneumonia, after second covid vaccination experienced fever, achiness and fatigue onset in 2021, after second covid vaccination experienced fever, achiness and fatigue onset in 2021 and after second covid vaccination experienced fever, achiness and fatigue onset in 2021 with RINVOQ(UPADACITINIB) was no reasonable possibility.  AbbVies opinion is that there is no reasonable possibility that the events of lupus, headache, asthma, joint pain, weight gain, covid-19, high blood pressure, oral thrush, low oxygen levels, recurrent pneumonia, joint swelling, vertigo, lost sense of smell, lost sense of taste, wheezing when breathing, gasping for air, after second covid vaccination experienced fever, achiness and fatigue onset in 2021, after second covid vaccination  Change History On 14May2020, received updates to event information, reporter opinion of causality and narrative description. The events of "headache" and "difficulty in breathing" were added. The event of "cough" was amended to "cough at night".  On 12Jan2021, received updates to event information, reporter opinion of causality, suspect drug information, laboratory/ diagnostic procedures and narrative description. The events of "asthma", "cold weather caused joint pain" and "weight gain" were added. The events of "difficulty in breathing" and "COUGH AT NIGHT" were removed.On 09Feb2021, received updates to event information, reporter opinion of causality, company opinion of causality, company alternative etiology, suspect drug information, laboratory/diagnostic procedures and narrative description. The events of "lupus", "COVID-19 PNEUMONIA", "high blood pressure", "thrush" and "low oxygen levels" were added.  On 01Mar2021, received updates to patient demographics, medical history, event information, reporter opinion of causality, company opinion of causality, company alternative etiology, suspect drug information, concomitant drug information, treatment drug information, laboratory/diagnostic procedures and narrative description. The event of "RECURRENT PNEUMONIA" was added. The event of "COVID-19 PNEUMONIA" was amended to "COVID-19". The event of "thrush" was amended to "oral thrush". On 09Sep2021, received updates to event information, reporter opinion of causality, company alternative etiology and narrative description. The event of "cold weather caused joint pain" was amended to "joint pain". On 11Sep2021, received updates to event information, reporter opinion of causality, company opinion of causality, company alternative etiology, concomitant drug information and narrative description. The events "joint swelling", "vertigo", "lost sense of smell" and "lost sense of taste" were added. On 08Oct2021, received updates to event information, reporter opinion of causality, company opinion of causality, company alternative etiology, suspect drug information, concomitant drug information and narrative description. The events of "wheezing when breathing", "gasping for air" and "after second covid vaccination experienced fever, achiness and fatigue" were added.  The reporter's assessment of the causal relationship of the events with the suspect product 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 lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.; Sender's Comments: Based on the limited information provided, causal relationship cannot be clearly established and cannot be excluded. There is no information when this subject received first dose of PFIZER BIONTECH COVID-19 VACCINE. Case will be reassessed upon receipt of additional information. 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.,Linked Report(s) : US-PFIZER INC-202101400082 same patient/drug, different dose/AE