Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Body temperature, Computerised tomogram, Magnetic resonance imaging, Posterior reversible encephalopathy syndrome
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of POSTERIOR REVERSIBLE ENCEPHALOPATHY SYNDROME (PRES (Medication on hold for patient to have Moderna booster, fever 101.8, vomiting, blurry vision, headache, blood pressure over 200)) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Previously administered products included for Lupus nephritis: LUPKYNIS (started treatment with 23.7 milligrams and twice daily(LOT 4244068AA)) on 01-Dec-2021. Past adverse reactions to the above products included No adverse event with LUPKYNIS. Concurrent medical conditions included Lupus nephritis. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Mar-2022, the patient experienced POSTERIOR REVERSIBLE ENCEPHALOPATHY SYNDROME (PRES (Medication on hold for patient to have Moderna booster, fever 101.8, vomiting, blurry vision, headache, blood pressure over 200)) (seriousness criteria hospitalization and medically significant). The patient was hospitalized from 02-Mar-2022 to 08-Mar-2022 due to POSTERIOR REVERSIBLE ENCEPHALOPATHY SYNDROME. At the time of the report, POSTERIOR REVERSIBLE ENCEPHALOPATHY SYNDROME (PRES (Medication on hold for patient to have Moderna booster, fever 101.8, vomiting, blurry vision, headache, blood pressure over 200)) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Mar-2022, Blood pressure measurement: more than 200 (High) more than 200. On 02-Mar-2022, Body temperature: 101.8 (High) 101.8. In March 2022, Computerised tomogram: posterior reversible encephalopathy syndrome (abnormal) Posterior reversible encephalopathy syndrome. In March 2022, Magnetic resonance imaging: posterior reversible encephalopathy syndrome (abnormal) Posterior reversible encephalopathy syndrome. On an unknown date, therapy with LUPKYNIS was temporarily interrupted one week prior to receiving Moderna COVID booster. At the time LUPKYNIS treatment was still on hold. Patient's symptoms included fever up to 101.8, vomiting, headache and blurry vision. She had bad reaction to vaccine. Patient had went to emergency department where her blood pressure was over 200, where patient was diagnosed with PRES. Patient was currently taking two new blood pressure medications. Relevant concomitant product usage were not reported by the reporter. The reporter assessed the causal relationship between LUPYKINS and the reaction to the Moderna vaccine booster as not related. The reporter did not provided the causal relationship between LUPYKINS and the PRES Posterior reversible encephalopathy syndrome as not related. Company Comment: This spontaneous case concerns a 50-year-old female patient, with relevant medical history of current lupus nephritis on Voclosporin, who experienced the unexpected serious (medically significant and hospitalization) event of Posterior reversible encephalopathy syndrome that occurred after receiving the booster dose of mRNA-1273 vaccine on an unknown date. Patient experienced fever 101.8 (unit not reported), vomiting, headache, blurry vision and blood pressure of over 200 (unit not reported) and was diagnosed with posterior reversible encephalopathy syndrome confirmed by CT/MRI. Clinical course and treatment details were not reported. Patient was discharged home after 6 days hospitalization. There was no information provided on the previous doses of vaccination. At the time of reporting, the outcome of event was unknown. The current lupus nephritis and Voclosporin (initiated 3 months and 2 days prior to the event and was put on hold 1 week prior to vaccination) remain as confounders since both can cause Encephalopathy. The benefit-risk relationship of mRNA-1273 is not affected by this report. Sender's Comments: This spontaneous case concerns a 50-year-old female patient, with relevant medical history of current lupus nephritis on Voclosporin, who experienced the unexpected serious (medically significant and hospitalization) event of Posterior reversible encephalopathy syndrome that occurred after receiving the booster dose of mRNA-1273 vaccine on an unknown date. Patient experienced fever 101.8 (unit not reported), vomiting, headache, blurry vision and blood pressure of over 200 (unit not reported) and was diagnosed with posterior reversible encephalopathy syndrome confirmed by CT/MRI. Clinical course and treatment details were not reported. Patient was discharged home after 6 days hospitalization. There was no information provided on the previous doses of vaccination. At the time of reporting, the outcome of event was unknown. The current lupus nephritis and Voclosporin (initiated 3 months and 2 days prior to the event and was put on hold 1 week prior to vaccination) remain as confounders since both can cause Encephalopathy. The benefit-risk relationship of mRNA-1273 is not affected by this report.