Age: 68.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Ankle fracture, Cough, Dysphonia, Hypoaesthesia, Magnetic resonance imaging
Clinical narrative: Pulmonary Embolism; Thoracic Spinal cord compression; Cough; Broken ankle; Numbness in lower body/numbess on both legs; Cold; Hoarseness; 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-163-4141736-00 (Agency).  A 69 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date Jan2021 (Batch/Lot number: unknown) at the age of 68 years as dose 1, single for covid-19 immunisation; upadacitinib (RINVOQ), oral since 2020 (ongoing) (Batch/Lot number: unknown) at 15 mg 1x/day for rheumatoid arthritis. Relevant medical history included: "High blood pressure" (unspecified if ongoing), notes: High blood pressure; "Hypothyroidism" (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), notes: Supplement; "broken ankle", start date: 10Aug2020 (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", notes: Tizanidine Allergy; Demerol, reaction(s): "Demerol Allergy", notes: Demerol Allergy; Betadine, reaction(s): "Betadine Allergy", notes: Betadine Allergy. The following information was reported: ANKLE FRACTURE (medically significant) with onset Aug2021, outcome "recovering", described as "Broken ankle"; SPINAL CORD COMPRESSION (medically significant) with onset Sep2021, outcome "recovering", described as "Thoracic Spinal cord compression"; PULMONARY EMBOLISM (hospitalization) with onset Sep2021, outcome "recovered", described as "Pulmonary Embolism"; HYPOAESTHESIA (non-serious) with onset 2021, outcome "recovering", described as "Numbness in lower body/numbess on both legs"; COUGH (non-serious) with onset 10Aug2021, 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". The patient underwent the following laboratory tests and procedures: magnetic resonance imaging: (Sep2021) t10 to l1 compression; (Sep2021) pulmonary embolism; x-ray limb: (10Aug2021) unknown results. The action taken for upadacitinib was dosage not changed. Therapeutic measures were taken as a result of ankle fracture, spinal cord compression, pulmonary embolism, hypoaesthesia, cough, nasopharyngitis, dysphonia.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.  Additional Information:   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 proce-dures 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". Solicited report by a consumer of a 69 year old female with events of Pulmonary Embolism, T10 to L1 Spine Compression and Broken Ankle and non-serious numbness in lower body/numbess on both legs, cough, cold and hoarseness with Rinvoq (Upadacitinib). On an unknown date, the patient experienced cough. On 10Aug2020, the patient experienced broken an-kle. Therapy dates for Pfizer Biontech Covid-19 Vaccine (Tozinameran)(Injection)(Tozinameran),(Unknown,Unknown was Jan2021- Jan2021, Aug2021 - Aug2021 In 2021, the patient experienced numbness in lower body/numbess 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. She had ankle broken in Aug2021 and had numbness in lower body. She was having surgery and was going to rehab. She mentioned that she was walking and suddenly her ankle popped and she was rushed to the emergency room Patient had ankle surgery on 19Aug2021. She was transferred to a rehab facility for recovery. Patient had an emergency back surgery due to T10 to L1 compression. She was hospitalized for five days due to Pulmonary embolism and spent 3 days in Intensive Care Unit. She was prescribed with an unknown antibiotic due to bad cold and cough. Primary reporter 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 reporter's 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 reporter's causality for the event(s) of broken ankle was not provided.  Agency's 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). Agency's opinion is that there is a reasonable possibility that the events of cough, cold and hoarseness are related to Rinvoq (Upadacitinib) Relevant Laboratory & Other Diagnostic Tests : 10Aug2021 Ankle Xray: Broken Ankle, Sep2021 Magnetic Resonance Imaging: T10 to L1 compression and Sep2021 Magnetic Resonance Imaging: Pulmonary Embolism.  Drug: Pfizer Biontech Covid-19 Vaccine(Tozinameran)(Tozinameran),Unknown,Unknown Causality: Pulmonary embolism (Pulmonary embolism), Action(s) taken with drug : Dose Not Changed, Causality as per reporter (drug/vaccine) : Not Related, Dechallenge : N/A Thoracic spinal cord compression (Spinal cord compression): Action(s) taken with drug : Dose Not Changed, Causality as per reporter (drug/vaccine) : Not Related, Dechallenge : N/A Broken ankle (Ankle fracture): Action(s) taken with drug : Dose Not Changed, Causality as per reporter (drug/vaccine) : Not Related, Dechallenge : N/A Numbness of lower extremities (Hypoaesthesia): Action(s) taken with drug: Dose Not Changed, Causality as per reporter (drug/vaccine) : Not Related, Dechallenge : N/A. Cough (Cough): Action(s) taken with drug : Dose Not Changed, Causality as per reporter (drug/vaccine) : Not Related, Dechallenge : N/A. Cold (Nasopharyngitis): Action(s) taken with drug : Dose Not Changed, Causality as per reporter (drug/vaccine) : Not Related, Dechallenge : N/A Hoarseness (Dysphonia): Action(s) taken with drug: Dose Not Changed, Causality as per reporter (drug/vaccine) : Not Related, Dechallenge : N/A.  Causality: Pulmonary embolism (Pulmonary embolism), Action(s) taken with drug : Dose Not Changed, Causality as per reporter (drug/vaccine) : Not Related, Causality as per Mfr.(Drug/Vaccine): No reasonable possibility, Dechallenge : N/A Thoracic spinal cord compression (Spinal cord compression): Action(s) taken with drug : Dose Not Changed, Causality as per reporter (drug/vaccine) : Not Related, Causality as per Mfr.(Drug/Vaccine): No reasonable possibility, Dechallenge : N/A Broken ankle (Ankle fracture): Action(s) taken with drug : Dose Not Changed, Causality as per reporter (drug/vaccine) : Not assessable, Causality as per Mfr.(Drug/Vaccine): No reasonable possibility, Dechallenge : N/A Numbness of lower extremities (Hypoaesthesia): Action(s) taken with drug : Dose Not Changed, Causality as per reporter (drug/vaccine) : Not Related, Causality as per Mfr.(Drug/Vaccine): No reasonable possibility, Dechallenge : N/A Cough (Cough): Action(s) taken with drug : Dose Not Changed, Causality as per reporter (drug/vaccine) : Not Related, Causality as per Mfr.(Drug/Vaccine): No reasonable possibility, Dechallenge : N/A Cold (Nasopharyngitis): Action(s) taken with drug : Dose Not Changed, Causality as per reporter (drug/vaccine) : Not Related, Causality as per Mfr.(Drug/Vaccine): No reasonable possibility, Dechallenge : N/A. Hoarseness (Dysphonia): Action(s) taken with drug : Dose Not Changed; Sender's Comments: Based on the available information it cannot be ascertained with reasonable possibility that suspect therapy BNT162B2 has caused/contributed to the reported events Broken ankle, Thoracic spinal cord compression, Pulmonary embolism, Numbness, Cough, Cold, Hoarseness, hence considered unrelated.