Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Ankle fracture, Cough, Dysphonia, Hypoaesthesia, Inappropriate schedule of product administration
Clinical narrative: pulmonary embolism; ankle broken; cough; T10 to L1 spine compression; therapy date: Jan2021/Aug2021; cold; hoarseness; numbness in lower body/numbness on both legs; 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-163-4141736-00.  A 69 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date Aug2021 (Batch/Lot number: unknown) at the age of 69 years as dose 2, single for covid-19 immunisation; upadacitinib (RINVOQ), oral, administration date 2020 (ongoing) (Batch/Lot number: unknown) as 15 mg, 1x/day for rheumatoid arthritis. Relevant medical history included: "Hypothyroidism" (unspecified if ongoing); "High blood pressure" (unspecified if ongoing); "Neuropathy" (unspecified if ongoing); "High Cholesterol" (unspecified if ongoing); "Depression" (unspecified if ongoing); "Muscle relaxant" (unspecified if ongoing); "Pain" (unspecified if ongoing); "Supplement" (unspecified if ongoing). Concomitant medication(s) included: LOSARTAN taken for hypertension; BUMEX taken for hypertension; LEVOTHYROXINE taken for hypothyroidism; GABAPENTIN taken for neuropathy peripheral; SIMVASTATIN taken for blood cholesterol increased; WELLBUTRIN taken for depression; FLEXERIL [CEFIXIME] taken for muscle relaxant therapy; PERCOCET [OXYCODONE HYDROCHLORIDE;OXYCODONE TEREPHTHALATE;PARACETAMOL] taken for pain; VITAMIN D [COLECALCIFEROL] taken for supplementation therapy. Past drug history included: Tizanidine, reaction(s): "Tizanidine Allergy"; Demerol, reaction(s): "Demerol Allergy"; Betadine, reaction(s): "Betadine Allergy"; Humira, start date: 2019, notes: Humira 40mg/0.8ml For Unknown Indication. Vaccination history included: Bnt162b2 (Dose:01, Route of Admin: Intramuscular), administration date: Jan2021, when the patient was 68 years old, for COVID-19 Immunization, reaction(s): "Broken ankle", "Cough", "Hoarseness", "Numbness in lower body/numbess on both legs", "Cold". The following information was reported: PULMONARY EMBOLISM (hospitalization, medically significant) with onset Sep2021, outcome "recovered" (2021), described as "pulmonary embolism"; ANKLE FRACTURE (medically significant), outcome "recovering", described as "ankle broken"; SPINAL CORD COMPRESSION (medically significant) with onset Sep2021, outcome "recovering", described as "T10 to L1 spine compression"; HYPOAESTHESIA (non-serious) with onset 2021, outcome "recovering", described as "numbness in lower body/numbness on both legs"; COUGH (non-serious), outcome "not recovered", described as "cough"; NASOPHARYNGITIS (non-serious) with onset 2021, outcome "not recovered", described as "cold"; DYSPHONIA (non-serious) with onset 2021, outcome "not recovered", described as "hoarseness"; INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset Aug2021, outcome "unknown", described as "therapy date: Jan2021/Aug2021". The patient was hospitalized for pulmonary embolism (hospitalization duration: 5 day(s)). The events "pulmonary embolism" and "ankle broken" were evaluated at the emergency room visit. The patient underwent the following laboratory tests and procedures: magnetic resonance imaging: (Sep2021) t10 to l1 compression; (Sep2021) pulmonary embolism; x-ray: (10Aug2021) broken ankle. The action taken for upadacitinib was dosage not changed. Therapeutic measures were taken as a result of pulmonary embolism, ankle fracture, spinal cord compression, hypoaesthesia, cough, nasopharyngitis, dysphonia.  Additional information: On an unknown date, the patient experienced cough. On 10Aug2020, the patient experienced broken ankle. In 2021, the patient experienced numbness in lower body/numbness on both legs, cold and hoarseness. In Sep2021, the patient experienced pulmonary embolism and T10 to L1 spine compression. In 2021, the pulmonary embolism resolved. Pfizer Biontech Covid-19 Vaccine (Tozinameran) was also considered suspect. The patient had a pulmonary embolism. The patient had ankle broken in Aug2021 and had numbness in lower body. The patient was having surgery and was going to rehab. The patient mentioned that the patient was walking and suddenly her ankle popped, and the patient was rushed to the emergency room Patient had ankle surgery on 19Aug2021. The patient was transferred to a rehab facility for recovery. The patient had an emergency back surgery due to T10 to L1 compression. The patient was hospitalized for five days due to Pulmonary embolism and spent 3 days in Intensive Care Unit. The patient was prescribed with an unknown antibiotic due to bad cold and cough. The patient did not have the lot number information, because the packaging was discarded. The patient was treated with Desolet, Codeine, Eliquis and Heparin. Causality for Rinvoq (Upadacitinib): The reporters causality for the event(s) of pulmonary embolism, T10 to L1 spine compression, numb-ness in lower body/numbess on both legs, cough, cold and hoarseness with Rinvoq (Upadacitinib) was no reasonable possibility. The reporters causality for the event(s) of broken ankle was not provided. AbbVies opinion is that there is no reasonable possibility that the events of pulmonary embolism, T10 to L1 spine compression, broken ankle and numbness in lower body/numbess on both legs are relat-ed to Rinvoq (Upadacitinib). AbbVies opinion is that there is a reasonable possibility that the events of cough, cold and hoarseness are related to Rinvoq (Upadacitinib). Change History: On 16Dec2021, received updates to medical history, event information, reporter opinion of causality, company opinion of causality, company alternative etiology, suspect drug information, concomitant drug information, treatment drug information, past drug information, laboratory/diagnostic procedures and narrative description. The events of "T10 TO L1 spine compression", "cough", "cold" and "hoarseness" were added. the event of "broken ankle" is now considered serious. the event of "numb-ness in lower body" was amended to "numbness in lower body/numbness on both legs". Check All Appropriate To Adverse Reaction: Involved or prolonged inpatient hospitalization and Other medically important condition.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on the information in the case, a contributory effect of the vaccine BNT162B2 to the reported events cannot be established. 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.