Age: 66.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Cardiomegaly, Oropharyngitis fungal, Oxygen saturation decreased, Pneumonia, Weight
Clinical narrative: Bilateral pneumonia; Heart enlarged; fungal infection on her lips, mouth, and throat where she could barely swallow.; Lost weight; Oxygen saturation low; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program (FACILITATED COLLECT). The reporter is the patient. Other Case identifier(s): 22K-163-4254354-00 (Agency).  A 66 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date 21Nov2021 (Batch/Lot number: unknown) at the age of 66 years as dose 3 (booster), single for covid-19 immunisation; upadacitinib (RINVOQ), oral (Batch/Lot number: unknown). The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, Single, Route of administration: Intramuscular), administration date: 01Feb2021, when the patient was 65 years old, for Covid-19 Immunization, reaction(s): "Cataract"; Bnt162b2 (Dose 2, Single, Route of administration: Intramuscular), administration date: 01Mar2021, when the patient was 65 years old, for Covid-19 Immunization, reaction(s): "Cataract", "Vaccination failure", "Covid-19". The following information was reported: PNEUMONIA (hospitalization, medically significant) with onset Jan2022, outcome "not recovered", described as "Bilateral pneumonia"; CARDIOMEGALY (hospitalization, medically significant) with onset Jan2022, outcome "not recovered", described as "Heart enlarged"; OROPHARYNGITIS FUNGAL (hospitalization, medically significant) with onset Jan2022, outcome "unknown", described as "fungal infection on her lips, mouth, and throat where she could barely swallow."; WEIGHT DECREASED (hospitalization, medically significant) with onset Jan2022, outcome "unknown", described as "Lost weight"; OXYGEN SATURATION DECREASED (hospitalization, medically significant) with onset Jan2022, outcome "not recovered", described as "Oxygen saturation low". The patient was hospitalized for pneumonia, cardiomegaly, oropharyngitis fungal, weight decreased, oxygen saturation decreased (start date: 09Jan2022). She had bi-lateral pneumonia and enlarged heart. She got moved to a regular room on 26Jan2022. She also has a possible fungal infection on her lips, mouth, and throat where she could barely swallow. She had also lost about 30 pounds. When she first got sick, her physician told her to stop the Rinvoq. The patient underwent the following laboratory tests and procedures: weight: (Jan2022) 30 pound, notes: lost. The action taken for upadacitinib was dosage permanently withdrawn.  Causality for Rinvoq (Upadacitinib): The reporters causality for the event of enlarged heart, fungal infection on lips, mouth, and throat where could barely swallow, oxygen got low and bilateral pneumonia with Rinvoq (Upadacitinib) was a reasonable possibility. The reporter's causality for the event lost about 30 pound was not provided. Agency's opinion is that there is no reasonable possibility that the events of enlarged heart, lost about 30 pound, oxygen got low, and bilateral pneumonia are related to Rinvoq(Upadacitinib). Agency's opinion is that the event of fungal infection on lips, mouth, and throat where could barely swallow is not assessable.  The reporter's assessment of the causal relationship of the events with the Pfizer Biontech Covid-19 Vaccine 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.  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 temporal relation, the association between the events of pneumonia, cardiomegaly, oropharyngitis fungal, weight decreased and oxygen saturation decreased and the suspect product of BNT162B2 cannot be completely ruled out. 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.