Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose, Blood glucose increased, Blood pressure measurement, Fatigue, Hypertension
Clinical narrative: Vision decreased; Hypertension; Glucose increased; Optic ischemic neuropathy; Psoriasis flare-up; Generalized aching; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of HYPERTENSION (Hypertension), VISUAL IMPAIRMENT (Vision decreased) and OPTIC ISCHAEMIC NEUROPATHY (Optic ischemic neuropathy) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) for Rheumatoid arthritis.    The patient's past medical history included Aorta substitution in 2019. Concurrent medical conditions included Diabetes.   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) at an unspecified dose. In 2021, the patient experienced PAIN (Generalized aching) and FATIGUE (Fatigue). On 13-Oct-2021, the patient experienced HYPERTENSION (Hypertension) (seriousness criteria hospitalization and medically significant). On 21-Oct-2021, the patient experienced PSORIASIS (Psoriasis flare-up). On 07-Dec-2021, the patient experienced OPTIC ISCHAEMIC NEUROPATHY (Optic ischemic neuropathy) (seriousness criterion medically significant). On an unknown date, the patient experienced VISUAL IMPAIRMENT (Vision decreased) (seriousness criteria hospitalization and medically significant) and BLOOD GLUCOSE INCREASED (Glucose increased). At the time of the report, HYPERTENSION (Hypertension) had not resolved and VISUAL IMPAIRMENT (Vision decreased), OPTIC ISCHAEMIC NEUROPATHY (Optic ischemic neuropathy), BLOOD GLUCOSE INCREASED (Glucose increased), PSORIASIS (Psoriasis flare-up), PAIN (Generalized aching) and FATIGUE (Fatigue) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-Oct-2021, Blood pressure measurement: Elevated. On an unknown date, Blood glucose: Elevated.         Patient was being in the hospital with increased blood pressure and decreased vision. Patient had been hospitalized twice due to hypertension. Patient was hungry a lot during the first three months of being on SKYRIZI.   This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. No concomitant medication information was reported. No treatment medication information was reported.  Company comment: This spontaneous case concerns a 58-year-old female patient, with relevant medical history aortic replacement and diabetes mellitus, treated with co-suspect drug Risankizumab for moderate to severe rheumatoid arthritis (start date not provided and no relevant medical history was reported) who experienced the unexpected serious (medically significant and hospitalization) events of Hypertension and Vision impairment, and unexpected serious (medically significant) event of Optic ischaemic neuoropathy after receiving the 2nd dose of mRNA-1273 vaccine. The event hypertension occurred 6 months and 12 days, and optic ischaemic neuropathy 8 months and 6 days, respectively, post vaccination, and vision impairment on unknown date. The events were reported along with the non-serious events of blood glucose increased and psoriasis flare up. Patient had elevated blood pressure and decreased vision. It was reported that patient was hospitalized twice due to hypertension. Clinical course and treatment details were not reported. The medical history of aortic replacement and diabetes mellitus could be considered as risk factors, and co-suspect drug Risankizumab for  rheumatoid arthritis could be considered as a confounder. Patient received 1st dose of mRNA-1273 vaccine 28 days prior to the 2nd dose. The benefit-risk relationship of mRNA-1273 is not affected by this report. Events assessed as serious based on medical judgement.   Most recent FOLLOW-UP information incorporated above includes: On 09-Mar-2022: Significant follow up: Narrative description updated.; Sender's Comments: This spontaneous case concerns a 58-year-old female patient, with relevant medical history aortic replacement and diabetes mellitus, treated with co-suspect drug Risankizumab for moderate to severe rheumatoid arthritis (start date not provided) who experienced the unexpected serious (medically significant and hospitalization) events of Hypertension and Vision impairment, and unexpected serious (medically significant) event of Optic ischaemic neuoropathy after receiving the 2nd dose of mRNA-1273 vaccine. The event hypertension occurred 6 months and 12 days, and optic ischaemic neuropathy 8 months and 6 days, respectively, post vaccination, and vision impairment on unknown date. The events were reported along with the non-serious events of blood glucose increased and psoriasis flare up. Patient had elevated blood pressure and decreased vision. It was reported that patient was hospitalized twice due to hypertension. Clinical course and treatment details were not reported. The medical history of aortic replacement and diabetes mellitus could be considered as risk factors, and co-suspect drug Risankizumab for rheumatoid arthritis could be considered as a confounder. Patient received 1st dose of mRNA-1273 vaccine 28 days prior to the 2nd dose. The benefit-risk relationship of mRNA-1273 is not affected by this report. Events assessed as serious based on medical judgement.