Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Loss of consciousness, Nausea
Clinical narrative: Dizziness; Loss of consciousness; Fatigue extreme; Nausea; This is a solicited report based on the information received by Pfizer from AbbVie Inc. (Manufacture facture Control Number: 21K-163-4071129-00). This non-contactable consumer (patient) reported that a 48-year-old female patient received bnt162b2 (Batch/Lot number was not reported), intramuscularly on an unspecified date as single dose for covid-19 immunization; upadacitinib (RINVOQ), orally from an unspecified date (Batch/Lot number was not reported) to an unspecified date, at unknown dose for moderate to severe rheumatoid arthritis. The patient's medical history and concomitant medications were not reported. The patient experienced dizziness, loss of consciousness, fatigue extreme, nausea in 2021. The events were serious per hospitalization. Solicited report by a consumer of an adult female with events of dizziness, loss of consciousness, extreme fatigue and nausea with upadacitinib (RINVOQ). There was no reported medical history. On unknown dates, the patient experienced dizziness, loss of consciousness, extreme fatigue and nausea. On unknown dates, dizziness and loss of consciousness resolved. Pfizer Biontech covid-19 vaccine (TOZINAMERAN) was also considered suspect. This patient reported been found on the kitchen floor unresponsive. Prior to that episode she states she was fighting extreme fatigue and nausea as well as dizziness. She was taken to the hospital and treated with diphenhydramine hydrochloride (BENADRYL) and two other medications she did not know the name of, then discharged. Adverse event information provided by her was related to covid vaccine. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. On unknown date, patient received COVID-19 Vaccine manufactured by Pfizer/BioNTech. The patient was treated with diphenhydramine hydrochloride. The action taken in response to the events for upadacitinib was permanently withdrawn on an unspecified date. Therapeutic measures were taken as a result of events. The outcome of events for dizziness and loss of consciousness was resolved in 2021, for other events was resolving. Causality for upadacitinib: The reporter's causality for the events of dizziness, loss of consciousness, extreme fatigue and nausea was not provided. Withheld opinion is that there is no reasonable possibility that the events of dizziness, loss of consciousness, extreme fatigue and nausea are related to upadacitinib.   The reporter's causality assessment for events of dizziness, loss of consciousness, extreme fatigue and nausea with bnt162b2 was possible.  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 known safety profile of the vaccine BNT162B2, a temporal relation between the events( dizziness, loss of consciousness,  fatigue and nausea) and the administration of the vaccine 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.