Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Hypertension, SARS-CoV-2 test
Clinical narrative: COVID; high blood pressure; mental and physical changes; blisters on face; This is a solicited report received from contactable reporter(s) (Consumer or other non-HCP, Physician). The reporter is the patient. Other Case identifier(s): 21K-163-4035165-00.  A 53-year-old female patient received BNT162b2 (BNT162B2), on 04Aug2021 as dose 1, single (Batch/Lot number: unknown) at the age of 53 years intramuscular for covid-19 immunisation; upadacitinib (RINVOQ), first regimen since Apr2021 (Lot number: 1139408) at 15 mg 1x/day (15 mg, 1x/day (1 in 1 d)), second regimen (Lot number: 1141059) at 15 mg 1x/day (15 mg, 1x/day (1 in 1 d)) and third regimen (ongoing) (Batch/Lot number: unknown) at 15 mg 1x/day (15 mg, 1x/day (1 in 1 d)), all oral for rheumatoid arthritis; losartan (LOSARTAN), (Batch/Lot number: unknown) for hypertension. The patient's relevant medical history was not reported. The patient had No known allergies. There were no concomitant medications.  The following information was reported: COVID-19 (medically significant) with onset 2021, outcome "recovered", described as "COVID"; Blister (non-serious) with onset 2021, outcome "unknown", described as "blisters on face"; Hypertension (non-serious) with onset 2021, outcome "unknown", described as "high blood pressure"; General Physical Health Deterioration (non-serious) with onset 2021, outcome "unknown", described as "mental and physical changes". The patient underwent the following laboratory tests and procedures: Blood pressure measurement: (unspecified date) High; Blood test: (unspecified date) All Good; SARS-CoV-2 test: (16Sep2021) positive; (Nov2021) Positive. The action taken for upadacitinib was dosage not changed; for losartan was unknown. Therapeutic measures were taken as a result of hypertension.  Additional information: Solicited report from a consumer of a 52-year-old female with events of non-serious General Physical Health Deterioration, blisters on face, high blood pressure and COVID with Rinvoq (upadacitinib). On an unknown date, the patient experienced COVID. In 2021, the patient experienced mental and physical changes, blisters on face, high blood pressure. COVID resolved. Losartan and Pfizer Biontech COVID-19 Vaccine (Tozinameran) were also considered suspect. Since the last fill the was having mental or physical changes that could be considered side effects of the medication. 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. She would be taking daily antibiotic and topical for rosacea, otherwise she reported positive result from Rinvoq. 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. The reporter's assessment of the causal relationship of "covid", "high blood pressure", "mental and physical changes" and "blisters on face" with the suspect product(s) BNT162b2 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. Causality for Rinvoq (Upadacitinib): The reporter's causality for the event(s) of COVID with Rinvoq (Upadacitinib) was no reasonable possibility. The reporter's causality for the event(s) of mental and physical changes onset in 2021, mental and physical changes onset in 2021, blisters on face and high blood pressure was not provided. The reporter's For COVID onset in Nov2021 with Rinvoq (upadacitinib) was a reasonable possibility. For RINVOQ: Causality for event General physical health deterioration, Blister, Blood pressure high (Hypertension) was not reported. Causality for COVID was not related. For LOSARTAN: Causality for event General physical health deterioration, Blister, Blood pressure high (Hypertension) was not reported. Causality for COVID was not related. For PFIZER BIONTECH COVID-19 VACCINE(TOZINAMERAN): Causality for event General physical health deterioration, Blister, Blood pressure high (Hypertension) was not reported. Causality for COVID was Probable.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the information available and close temporal association, a possible contributory role of the suspect Product cannot be excluded for the reported events . The case will be reassessed once new information is available.