Age: 69.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Vaccination site pain
Clinical narrative: cracked vertebrae; inflammation in lungs; Nodules all over hands; twisted back; Had a sore arm; Vaccination site pain;   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-163-4161006-00.  A 69 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date 26Aug2021 (Batch/Lot number: unknown) at the age of 69 years as dose 1, single and intramuscular, administration date 16Sep2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation; upadacitinib (RINVOQ), oral (Batch/Lot number: unknown) for rheumatoid arthritis. Relevant medical history included: "Moderate to severe rheumatoid arthritis" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: SPINAL FRACTURE (medically significant) with onset 2021, outcome "unknown", described as "cracked vertebrae"; PNEUMONITIS (non-serious) with onset 2021, outcome "not recovered", described as "inflammation in lungs"; NODULE (non-serious) with onset 2021, outcome "not recovered", described as "Nodules all over hands"; LIGAMENT SPRAIN (non-serious) with onset 2021, outcome "unknown", described as "twisted back"; PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "unknown", described as "Had a sore arm"; VACCINATION SITE PAIN (non-serious) with onset 2021, outcome "unknown", described as "Vaccination site pain". The action taken for upadacitinib was dosage permanently withdrawn. Therapeutic measures were taken as a result of pneumonitis. The patient had inflammation in lungs, and was on antibiotics for lungs, not currently taking RINVOQ due to antibiotics as of 12Nov2021. She had nodules all over hands as of 01Nov2021. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Causality for Rinvoq (UPADACITINIB): The reporters causality for the event(s) of inflammation in lungs with RINVOQ(UPADACITINIB) was a reasonable possibility, nodules all over hands, after lifting bottle of water, twisted back and cracked vertebrae unknown onset, after lifting bottle of water, twisted back and cracked vertebrae unknown onset and from Pfizer vaccine had a sore arm was not provided. Causality for Pfizer BioNTech Covid-19 vaccine: was not reported for the events Nodule on extremity (Nodule), Back sprain (Ligament sprain), Fractured vertebra (Spinal fracture), Vaccination site pain (Vaccination site pain) and Lung inflammation (Pneumonitis). No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on available information, a possible contributory role of BNT162B2 vaccine can not be excluded for the reported events of Spinal fracture, Pneumonitis, Nodule, Ligament sprain, Pain in extremity, Vaccination site pain. 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.