Age: 76.0
Sex: U
Vaccine: COVID19
Symptoms: Illness, Interchange of vaccine products, Mobility decreased, Paralysis, SARS-CoV-2 test
Clinical narrative: delirious; I was paralysed for a good 2 or 3 minutes; I have felt worse than the one before./ each dose is worse than the one before; I felt that ill; I could not move my legs / I was paralysed for a good 2 or 3 minutes; was bed ridden for nearly a week; most awful headache; vomiting; interchange of vaccine product; Revaccination with different COVID-19 vaccine; This spontaneous case was reported by a patient and describes the occurrence of DELIRIUM (delirious) and PARALYSIS (I was paralysed for a good 2 or 3 minutes) in a 76-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     Previously administered products included for Drug use for unknown indication: AstraZeneca (1st dose) in January 2021, AstraZeneca (2nd dose) in April 2021 and PFIZER BIONTECH COVID-19 VACCINE (Booster vaccine) in October 2021. Past adverse reactions to the above products included No adverse event with AstraZeneca, AstraZeneca and PFIZER BIONTECH COVID-19 VACCINE.    In May 2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DELIRIUM (delirious) (seriousness criterion medically significant), PARALYSIS (I was paralysed for a good 2 or 3 minutes) (seriousness criterion medically significant), FEELING ABNORMAL (I have felt worse than the one before./ each dose is worse than the one before), ILLNESS (I felt that ill), MOBILITY DECREASED (I could not move my legs / I was paralysed for a good 2 or 3 minutes), BEDRIDDEN (was bed ridden for nearly a week), HEADACHE (most awful headache), VOMITING (vomiting), INTERCHANGE OF VACCINE PRODUCTS (interchange of vaccine product) and COVID-19 IMMUNISATION (Revaccination with different COVID-19 vaccine). At the time of the report, DELIRIUM (delirious), PARALYSIS (I was paralysed for a good 2 or 3 minutes), FEELING ABNORMAL (I have felt worse than the one before./ each dose is worse than the one before), ILLNESS (I felt that ill), MOBILITY DECREASED (I could not move my legs / I was paralysed for a good 2 or 3 minutes), BEDRIDDEN (was bed ridden for nearly a week), HEADACHE (most awful headache), VOMITING (vomiting), INTERCHANGE OF VACCINE PRODUCTS (interchange of vaccine product) and COVID-19 IMMUNISATION (Revaccination with different COVID-19 vaccine) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In October 2020, SARS-CoV-2 test: Positive.         Concomitant medication list was not provided. Treatment information was not provided.  Company comment: This is a spontaneous case concerning a 76 years old unspecified gender, with no relevant medical history, who experienced unexpected serious (medically significant) events of delirium, paralysis, which occurred unspecified days after fourth dose of mRNA-1273 vaccine. Additionally non serious events mobility decreased, bedridden. The patient received two doses of VAXZEVRIA APPROXIMETLY 13 months prior to mRNA-1273 vaccine and one dose of TOZINAMERAN (interchange of vaccine products) approximately 6 months prior to mRNA-1273 vaccine. Patient experienced after last dose of vaccination patient was delirious replaying to questions asked with totally irrelevant answers, not able to move legs for 2 to 3 minutes, patient taught he was paralysed, patient had headache, vomiting and was bedridden foe a week. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a 76 years old unspecified gender, with no relevant medical history, who experienced unexpected serious (medically significant) events of delirium, paralysis, which occurred unspecified days after fourth dose of mRNA-1273 vaccine. Additionally non serious events mobility decreased, bedridden. The patient received two doses of VAXZEVRIA APPROXIMETLY 13 months prior to mRNA-1273 vaccine and one dose of TOZINAMERAN (interchange of vaccine products) approximately 6 months prior to mRNA-1273 vaccine. Patient experienced after last dose of vaccination patient was delirious replaying to questions asked with totally irrelevant answers, not able to move legs for 2 to 3 minutes, patient taught he was paralysed, patient had headache, vomiting and was bedridden foe a week. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.