Sex: F
Vaccine: COVID19, UNK
Symptoms: Vaccination site pain
Clinical narrative: Booster dose; Cardiac pain/ felt like was having heartache; Vaccination site pain/ COVID-19 vaccine left, shoulder arm was sore; ribs were sore; Mobility decreased/ COVID-19 vaccine left, shoulder arm and ribs were sore could hardly move it; Nauseated; MARKECTING PROGRAM NAME NOT AVAILABLE  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-163-4173036-00 (Abbvie).  A 55 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation; upadacitinib (RINVOQ), oral (Batch/Lot number: unknown) for rheumatoid arthritis. The patient's relevant medical history and concomitant medications were not reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Vaccination history included: Covid-19 vaccine  (Dose number unknown, MANUFACTURE UNKNOWN). The following information was reported: IMMUNISATION (medically significant), outcome "unknown", described as "Booster dose"; ANGINA PECTORIS (medically significant), outcome "unknown", described as "Cardiac pain/ felt like was having heartache "; VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "Vaccination site pain/ COVID-19 vaccine left, shoulder arm was sore"; MUSCULOSKELETAL CHEST PAIN (non-serious), outcome "unknown", described as "ribs were sore"; MOBILITY DECREASED (non-serious), outcome "unknown", described as "Mobility decreased/ COVID-19 vaccine left, shoulder arm and ribs were sore could hardly move it"; NAUSEA (non-serious), outcome "unknown", described as "Nauseated". The action taken for upadacitinib was unknown. The patient had soreness in his left shoulder and arm and ribs that he could hardly move after the administration of COVID-19 vaccine. She had felt nauseated and like having a heartache.  The reporter considered "cardiac pain/ felt like was having heartache ", "vaccination site pain/ covid-19 vaccine left, shoulder arm was sore", "mobility decreased/ covid-19 vaccine left, shoulder arm and ribs were sore could hardly move it" and "nauseated" related to bnt162b2.  Causality for Rinvoq (Upadacitinib): The reporter's causality for the event(s) of after had COVID-19 vaccine left, shoulder arm and ribs were sore could hardly move it unknown onset, after had COVID-19 Vaccine Left, Shoulder Arm and ribs were sore could hardly move it unknown onset, felt like was having heartache and felt nauseated was not provided.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association between the reported events with the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available. 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.