Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Catheter placement, Gout, Lymphoedema, Pain in extremity
Clinical narrative: Catheter placement; Gout; Lymphedema; Pain in arm; 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 20Feb2021 (Batch/Lot number: unknown) at the age of 72 years as dose 2, single and intramuscular, administration date Jan2021 (Batch/Lot number: unknown) as dose 1, 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. The following information was reported: CATHETER PLACEMENT (medically significant), outcome "recovering", described as "Catheter placement"; GOUT (non-serious), outcome "unknown", described as "Gout"; PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "recovered" (2021), described as "Pain in arm"; LYMPHOEDEMA (non-serious), outcome "unknown", described as "Lymphedema". The patient underwent the following laboratory tests and procedures: blood pressure measurement: (2021) high. The action taken for upadacitinib was unknown. It was reported that, solicited report by a consumer of a 73-year-old female with events of catheter placement and non-serious gout, pain in arm, lymphedema with RINVOQ (UPADACITINIB). There was no reported medical history. PFIZER BIONTECH COVID-19 VACCINE (TOZINAMERAN) was also considered suspect. Stated that, 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. Stated that, she would know for sure until she went back to the physician for the follow up next. Stated that, she only had pain in arm with all Covid-19 vaccines. It was unknown whether the patient was enrolled in a COVID-19 Vaccine trial.  Causality for RINVOQ (UPADACITINIB) The reporter's causality for the event(s) of catheter placement was not reported. The reporter's causality for the event(s) of gout, pain in arm and lymphedema with RINVOQ (UPADACITINIB) was no reasonable possibility. Authority's opinion was that there was no reasonable possibility that, the events of catheter placement, gout, pain in arm are related to RINVOQ (UPADACITINIB). Authority's opinion was that the event of lymphedema was not assessable.   Causality for PFIZER BIONTECH COVID-19 VACCINE (TOZINAMERAN) The reporter's causality as per reporter for the events catheter placement, gout, lymphedema was not related and for the event pain in arm was not reported.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: The event of pain in arm is related to the suspect product BNT162B2 based on plausible temporal relationship. The events of catheter placement, gout and lymphoedema are unrelated to the suspect product BNT162B2 since these events are associated with chronic medical conditions with long latency period.