Age: 67.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Allergic cough, Arthralgia, Pain, Rheumatoid arthritis, Sneezing
Clinical narrative: Rheumatoid arthritis flare up; Allergies with coughing; Sneezing; Booster of Pfizer vaccine caused  shoulder pain; Booster of Pfizer vaccine caused sore arm; Felt achy/The patient had occasional achiness; 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-163-4269841-00.  A 67 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date 28Jan2022 (Batch/Lot number: unknown) at the age of 67 years as dose 3 (booster), single for covid-19 immunisation; upadacitinib (RINVOQ), oral (ongoing) (Batch/Lot number: unknown) for rheumatoid arthritis. Relevant medical history included: "Interchange of vaccines products" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Moderna covid-19 vaccine (1st dose (1 in 1 Once)), administration date: 27Jul2021, when the patient was 66 years old, for Covid-19 immunization; Moderna covid-19 vaccine (2nd dose (1 in 1 Once)), administration date: 20Aug2021, when the patient was 66 years old, for Covid-19 immunization. The following information was reported: RHEUMATOID ARTHRITIS (medically significant), outcome "not recovered", described as "Rheumatoid arthritis flare up"; ARTHRALGIA (non-serious) with onset 2022, outcome "unknown", described as "Booster of Pfizer vaccine caused  shoulder pain"; VACCINATION SITE PAIN (non-serious) with onset 2022, outcome "unknown", described as "Booster of Pfizer vaccine caused sore arm"; PAIN (non-serious) with onset 2022, outcome "unknown", described as "Felt achy/The patient had occasional achiness"; ALLERGIC COUGH (non-serious), outcome "not recovered", described as "Allergies with coughing"; SNEEZING (non-serious), outcome "not recovered", described as "Sneezing". The action taken for upadacitinib was dosage not changed.  Change History:On 07Mar2022, received updates to event information, reporter opinion of causality, suspect drug information, concomitant drug information and narrative description. The events of "ALLERGIES WITH COUGHING" and "SNEEZING" were added. The event of "BOOSTER OF MODERNA VACCINE CAUSED SHOULDER PAIN" was amended to "BOOSTER OF PFIZER VACCINE CAUSED SHOULDER PAIN". The event of "BOOSTER OF MODERNA VACCINE CAUSED SORE ARM" was amended to "BOOSTER OF PFIZER VACCINE CAUSED SORE ARM".  The reporter's causality for the event(s) of BOOSTER OF PFIZER VACCINE CAUSED SHOULDER PAIN, BOOSTER OF PFIZER VACCINE CAUSED SORE ARM, FELT ACHY, ALLERGIES WITH COUGHING and SNEEZING with RINVOQ(UPADACITINIB) was no reasonable possibility. The reporter's causality for the event(s) of RHEUMATOID ARTHRITIS FLARE UP with RINVOQ(UPADACITINIB) was a reasonable possibility.  The reporter's causality for the event(s) Shoulder pain, Vaccination site pain with PFIZER BIONTECH COVID-19 VACCINE (TOZINAMERAN) was possible and Ache, Allergic cough, Sneezing and Rheumatoid arthritis flare up with PFIZER BIONTECH COVID-19 VACCINE (TOZINAMERAN)  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: Based on the information provided in the narrative , a possible contributory role of the suspect vaccine BNT162B2 to reported event of  Vaccination site pain,Shoulder pain,Ache, Allergic cough, Sneezing and Rheumatoid arthritis flare up  cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.