Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Paralysis, Tremor, Vision blurred
Clinical narrative: paralyzed; felt she was going to pass out; could not open her right eye; blurred vision; peed and pooed at the same/did not have control of her bladder; little shaky; dizzy; was so weak; bad headache; This spontaneous case was reported by a consumer and describes the occurrence of PARALYSIS (paralyzed) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 065F21A, 031L20A and 012L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Nov-2021, the patient experienced PARALYSIS (paralyzed) (seriousness criterion medically significant), DIZZINESS (felt she was going to pass out), OCULAR DISCOMFORT (could not open her right eye), VISION BLURRED (blurred vision), BLADDER DISCOMFORT (peed and pooed at the same/did not have control of her bladder), TREMOR (little shaky), DIZZINESS (dizzy), ASTHENIA (was so weak) and HEADACHE (bad headache). At the time of the report, PARALYSIS (paralyzed), DIZZINESS (felt she was going to pass out), OCULAR DISCOMFORT (could not open her right eye), VISION BLURRED (blurred vision), BLADDER DISCOMFORT (peed and pooed at the same/did not have control of her bladder), TREMOR (little shaky), DIZZINESS (dizzy), ASTHENIA (was so weak) and HEADACHE (bad headache) outcome was unknown.            No concomitant drug details were reported. patient had gait disturbance and musculoskeletal discomfort  Husband called 911 and they checked patient's heart and BP. Patient could not even walk to the ambulance when she was being taken to the emergency room. At the ER, they did and EKG and urinalysis.   No treatment details were reported. Company Comment: This case concerns a 63-year-old, female patient, with no disclosed medical history, who experienced the serious, unexpected event of paralysis. The event  occurred  on the same day after booster dose of mRNA 1273 vaccine. The patient had a bad headache at night, she slept a while, her husband tried to wake her up, after some time, she woke up but with blurred vision, feeling faint, weak and was unable to walk. They went to the emergency room where and EKG and urinalysis were done, results were not provided. Patient was sent home from the ER but is still not recovered. The rechallenge is not applicable as no additional dose is expected. The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report.   This case was linked to MOD-2021-378365 (Patient Link).; Sender's Comments: This case concerns a 63-year-old, female patient, with no disclosed medical history, who experienced the serious, unexpected event of paralysis. The event  occurred  on the same day after booster dose of mRNA 1273 vaccine. The patient had a bad headache at night, she slept a while, her husband tried to wake her up, after some time, she woke up but with blurred vision, feeling faint, weak and was unable to walk. They went to the emergency room where and EKG and urinalysis were done, results were not provided. Patient was sent home from the ER but is still not recovered. The rechallenge is not applicable as no additional dose is expected. The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report.