Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Catheter placement, Headache, Hypertension, Immunisation
Clinical narrative: Catheter; Bad headache; Blood pressure was high; sore arm; booster; 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): 21K-163-4189167-00.  A 73 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date 2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation; upadacitinib (RINVOQ), oral (Lot number: 1141056) for rheumatoid arthritis. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose:02, Daily Dose: 1 in 1 once, Route of administration: Intramuscular), administration date: 20Feb2021, when the patient was 72 years old, for COVID-19 VACCINATION, reaction(s): "Gout", "Sore arm", "Lymphedema"; Bnt162b2 (Dose:01, Daily Dose: 1 in 1 once, Route of administration: Intramuscular), administration date: Jan2021, when the patient was 72 years old, for COVID-19 VACCINATION, reaction(s): "Gout", "Lymphedema", "Sore arm".  The following information was reported: IMMUNISATION (non-serious) with onset 2021, outcome "unknown", described as "booster"; CATHETER PLACEMENT (medically significant), outcome "recovering", described as "Catheter"; PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "unknown", described as "sore arm"; HEADACHE (non-serious) with onset Dec2021, outcome "unknown", described as "Bad headache"; HYPERTENSION (non-serious) with onset Dec2021, outcome "unknown", described as "Blood pressure was high". The patient underwent the following laboratory tests and procedures: blood pressure measurement: (2021) high. The action taken for upadacitinib was unknown.  The reporters causality for the events of catheter, bad headache and blood pressure was high was not provided. the reporters causality for the events of gout, sore arm and lymphedema with rinvoq (upadacitinib) was no reasonable possibility. abbvies opinion is that there is no reasonable possibility that the events of catheter, gout, sore arm and bad headache are related to rinvoq (upadacitinib). abbvies opinion is that the events of lymphedema and blood pressure was high are not assessable.  The patient was going to a follow up heart physician for her catheter. The physician found that the swelling in her leg and feet were due to the Gout and or Lymphedema. She would know for sure until she went back to the physician for the follow up next. She had just a sore arm from her Covid-19 vaccine booster. She got a bad headache and her blood pressure was high. She thought it was due to a strong cologne a man was wearing. She only had sore arm with all Covid-19 vaccines.It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  Causality as per reporter for the events Catheter placement (Catheter placement),Gout (Gout), Lymphedema (Lymphoedema),Headache (Headache), Blood pressure high (Hypertension) is Not Related and for the event Pain in arm (Pain in extremity) is Not Reported.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on known mechanism of action of the drugs, the event of Catheter placement ,Gout , Lymphedema ,Headache , Blood pressure high is assessed as not related to BNT162B2.