Age: 53.0
Sex: F
Vaccine: COVID19, UNK, UNK
Symptoms: General physical health deterioration, Hypertension, Investigation, Mental disorder, Paranasal sinus hypersecretion
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 21K-163-4035165-00 (AbbVie). A 54-year-old female patient received BNT162b2 (BNT162B2), on 25Aug2021 as dose 2, single (Batch/Lot number: unknown) at the age of 53 years intramuscular for covid-19 immunization; upadacitinib (RINVOQ), first regimen since Apr2021 (Lot number: 1139408) at 15 mg 1x/day, second regimen (Lot number: 1141059) at 15 mg 1x/day and third regimen (ongoing) (Batch/Lot number: unknown) at 15 mg 1x/day, all oral for rheumatoid arthritis; losartan (LOSARTAN), (Batch/Lot number: unknown) for hypertension. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose: 1, Route of administration: Intramuscular), administration date: 04Aug2021, when the patient was 53-year-old, for COVID-19 Vaccination. The following information was reported: BLISTER (non-serious) with onset 2021, outcome "unknown", described as "Blisters on face"; PARANASAL SINUS HYPERSECRETION (non-serious) with onset 2021, outcome "not recovered", described as "Drainage from sinuses"; HYPERTENSION (non-serious) with onset 2021, outcome "unknown", described as "High blood pressure"; MENTAL DISORDER (non-serious), GENERAL PHYSICAL HEALTH DETERIORATION (non-serious) all with onset 2021, outcome "unknown" and all described as "Mental and physical changes"; ROSACEA (non-serious) with onset 2021, outcome "not recovered"; AGEUSIA (non-serious), ANOSMIA (non-serious) all with onset 16Sep2021, outcome "unknown" and all described as "she lost her taste, she could not smell or taste anything"; EPISTAXIS (non-serious) with onset 01Dec2021, outcome "recovered" (31Jan2022), described as "Nose bleed". The event "nose bleed" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. The action taken for upadacitinib was dosage not changed; for losartan was unknown. Therapeutic measures were taken as a result of rosacea, hypertension. Additional information: On an unknown date, the patient experienced COVID and resolved. Since the last fill the was having mental or physical changes that could be considered side effects of the medication. She had nose bleed which was lasting over an hour, and blisters on the face. Her md and her local pharmacist was not concerned this was from Rinvoq or rather due to the Losartan she was taking. She underwent testing and noted high blood pressure and was prescribed Losartan. She then started experiencing blisters on face, dermatologist diagnosed as rosacea. She would be taking daily antibiotic and topical for rosacea, otherwise she reported positive result from Rinvoq. Patient lost her taste, could not smell anything. Physician required to stop Rinvoq. She had COVID four days before her appointment and she had blood work that was also done and everything was good. No concomitant drugs taken. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. On 20Sep2021, 10Jan2022, 16Mar2022, 18Jul2022, received updates to event information, reporter opinion of causality, suspect drug information, concomitant drug information, laboratory/diagnostic procedures, narrative description and medical history and the event of "COVID" was added. The event abate after stopping drug was not applicable. No known allergies were reported. The reporter's causality for the events with Comirnaty was not reported and for Covid-19 was probable. The reporter's causality for the event(s) of nose bleed and COVID with Rinvoq (Upadacitinib) was no reasonable possibility. The reporter's causality for the event(s) of mental and physical changes, blisters on face onset in 2021 and high blood pressure was not provided. The reporter's For COVID onset in November 2021 with Rinvoq (upadacitinib) was a reasonable possibility. The reporter's causality for the events with Losartan was not reported. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.