Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram, Horner's syndrome, Hypertension, Pulmonary embolism
Clinical narrative: Had CT done results showed multiple pulmonary emboli at least 15 in both lungs; Cervical fusion done 15Mar2021 developed Horner's syndrome which lead to high blood pressure; developed Horner's syndrome which lead to high blood pressure; This spontaneous case was reported by a nurse and describes the occurrence of PULMONARY EMBOLISM (Had CT done results showed multiple pulmonary emboli at least 15 in both lungs), HORNER'S SYNDROME (Cervical fusion done 15Mar2021 developed Horner's syndrome which lead to high blood pressure) and HYPERTENSION (developed Horner's syndrome which lead to high blood pressure) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029L20A and 026L20A) for COVID-19 vaccination.     The patient's past medical history included Fusion cervical spine on 15-Mar-2021. Previously administered products included for Product used for unknown indication: flu vaccine (She had a flu vaccine about 6 months ago). Past adverse reactions to the above products included No adverse event with flu vaccine. Concurrent medical conditions included Drug allergy (morphine drops blood pressure) and Drug allergy (Sulfa). Concomitant products included LISINOPRIL, OMEPRAZOLE (PROTONIX [OMEPRAZOLE]), DIAZEPAM, METOPROLOL, SIMVASTATIN, LOPERAMIDE and TRAMADOL HYDROCHLORIDE (TRAMADOL [TRAMADOL HYDROCHLORIDE]) for an unknown indication.   On 28-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Dec-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PULMONARY EMBOLISM (Had CT done results showed multiple pulmonary emboli at least 15 in both lungs) (seriousness criteria hospitalization and medically significant). On an unknown date, the patient experienced HORNER'S SYNDROME (Cervical fusion done 15Mar2021 developed Horner's syndrome which lead to high blood pressure) (seriousness criterion medically significant) and HYPERTENSION (developed Horner's syndrome which lead to high blood pressure) (seriousness criterion medically significant). The patient was treated with APIXABAN (ELIQUIS) at a dose of 5 milligram twice a day and Surgery (emergency surgery at midnight most of emboli out but not all of them) for Pulmonary embolism. At the time of the report, PULMONARY EMBOLISM (Had CT done results showed multiple pulmonary emboli at least 15 in both lungs), HORNER'S SYNDROME (Cervical fusion done 15Mar2021 developed Horner's syndrome which lead to high blood pressure) and HYPERTENSION (developed Horner's syndrome which lead to high blood pressure) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-Dec-2021, Computerised tomogram: ct done results showed multiple pulmonary emboli a CT done results showed multiple pulmonary emboli at least 15 in both lungs.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient received 2 doses of mRNA-1273 vaccine on 28 Dec 2020 & 22 Jan 2021. On 15 Mar 2021, cervical fusion was done for an unknown indication. On an unknown date, she developed horner syndrome which led to high blood pressure per the reporter. On 29 Dec 2021, patient could not breathe necessitating ER consultation. CT scan showed multiple pulmonary emboli reportedly at least 15 in both lungs which prompted emergency surgery. Eliquis 5 mg 2x a day was also given. Patient's medical history included flu vaccine 6 months prior to her COVID-19 vaccination, confirmed allergies to morphine drops blood pressure and sulfa, & denied hypertension. Concomitant medications for unknown indications were reported.  Company Comment: This spontaneous case concerns a 65-year-old, female patient, with no relevant medical history reported, who experienced the unexpected, medically significant serious events of an AESI Pulmonary embolism, Horner syndrome, & Hypertension in association with mRNA-1273 vaccine. Interval between doses 1 and 2 of mRNA-1273 vaccine was 24 days. Exact onset latency of the events Horner syndrome & Hypertension cannot be established with unknown start dates of said events. Reportedly, she developed Horner syndrome which allegedly led to her unusual high blood pressure. Patient reported breathing difficulties resulting to ER consultation 11 months after receiving her 2nd dose of mRNA-1273 vaccine. CT scan result showed multiple pulmonary emboli at least 15 in both lungs which prompted emergency surgery. Eliquis 5mg was also given as a treatment. The benefit-risk relationship of mRNA-1273 is not affected by this report. Events' seriousness assessed based on medical judgement and the available information.; Sender's Comments: This spontaneous case concerns a 65-year-old, female patient, with no relevant medical history reported, who experienced the unexpected, medically significant serious events of an AESI Pulmonary embolism, Horner syndrome, & Hypertension in association with mRNA-1273 vaccine. Interval between doses 1 and 2 of mRNA-1273 vaccine was 24 days. Exact onset latency of the events Horner syndrome & Hypertension cannot be established with unknown start dates of said events. Reportedly, she developed Horner syndrome which allegedly led to her unusual high blood pressure. Patient reported breathing difficulties resulting to ER consultation 11 months after receiving her 2nd dose of mRNA-1273 vaccine. CT scan result showed multiple pulmonary emboli at least 15 in both lungs which prompted emergency surgery. Eliquis 5mg was also given as a treatment. The benefit-risk relationship of mRNA-1273 is not affected by this report. Events' seriousness assessed based on medical judgement and the available information.