Age: 66.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: COVID-19, Drug ineffective, Oxygen consumption, Oxygen consumption decreased, Pyrexia
Clinical narrative: oxygen got low; COVID-19; COVID-19; Fever; FACILITATED COLLECT  This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. 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, intramuscular, administration date 01Mar2021 (Batch/Lot number: unknown) as dose 2, single and intramuscular, administration date 01Feb2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation; upadacitinib (RINVOQ), oral (Lot number: 1150525). The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (caused and prolonged hospitalization, medically significant) with onset 01Jan2022, outcome "unknown", COVID-19 (caused and prolonged hospitalization, medically significant) with onset 01Jan2022, outcome "recovering" and all described as "COVID-19"; PYREXIA (caused and prolonged hospitalization, medically significant) with onset 2022, outcome "not recovered", described as "Fever"; OXYGEN CONSUMPTION DECREASED (hospitalization, medically significant) with onset 2022, outcome "not recovered", described as "oxygen got low". The patient was hospitalized and prolonged hospitalization for drug ineffective, covid-19, pyrexia (start date: 09Jan2022); for oxygen consumption decreased (start date: 09Jan2022). The patient underwent the following laboratory tests and procedures: oxygen consumption: (unspecified date) low, notes: oxygen got low; sars-cov-2 test: (01Jan2022) positive; weight: (unspecified date) lost, notes: Lost 30 pound. The action taken for upadacitinib was unknown.  The reporters causality for the event(s) of Covid-19, Oxygen Got Low, Fever was a reasonable possibility. Agency opinion is that there is no reasonable possibility that the events of COVID-19, Oxygen Got Low, Fever are related to RINVOQ(UPADACITINIB). . For Pfizer Biontech Covid-19 Vaccine Causality as per reporter COVID-19 is possible. Event abate after stopping Drug.  Clinical information: Solicited report from a consumer of an adult female with events of Covid-19, Oxygen Got Low, Fever With Rinvoq (Upadacitinib). There was no reported medical history. On unknown dates, the patient experienced Oxygen Got Low, Fever. In Mar2021, the patient experienced Cataract Surgery. On 01Jan2022, the patient experienced COVID-19. On an unknown date, Cataract Surgery resolved. PFIZER BIONTECH COVID-19 VACCINE (TOZINAMERAN) was also considered suspect. The patient test had cataract surgery in Mar2021. She tested positive for covid on 01Jan2022. She had a fever and her oxygen got low. She had been in the hospital since 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 lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on known drug safety profile, there is  reasonable possibility of causal association between the events DRUG INEFECTIVE, COVID-19, FEVER,  OXYGEN CONSUMPTION DECREASED and the suspect drug BNT162B2